THESIS PROTOCOL

TITLE

Microalbuminuria as a Prognostic Marker in Patients with Acute Ischemic

Stroke admitted to a Tertiary Hospital in Bangladesh

INVESTIGATOR:

DR. SHARMIN AKTER,

Residency: (Phase B student),

MD (Internal Medicine)

Session: September 2019

GUIDE:
DR. SHOMAN SARKER,
Associate Professor,
MBBS, MD (Medicine),
Department of Medicine,
Chittagong Medical College
To

The Principal
Chittagong Medical College
Chattogram.

Subject: Application for the approval of Thesis Protocol with the title, “Microalbuminuria
as a Prognostic Marker in Patients with Acute Ischemic Stroke admitted to a Tertiary
Hospital in Bangladesh”

Sir,

With due respect and humble submission, I would like to state that I am a student of MD
residency (Internal Medicine), Phase-B at BSMMU, Dhaka. As per requirement of the
course, I would like to perform my research work on the thesis with the above-mentioned title
under the direct supervision of Dr. Shoman Sarker, Associate Professor, Department of
Medicine, Chittagong Medical College and Hospital, Chattogram, Bangladesh.

I therefore, like to request you to approve my protocol so that I can commence my work in
your esteemed institute to complete my thesis in due time.

Obediently Yours

DR. Sharmin Akter

MD (Internal Medicine-Phase B)
Department of Medicine
Chittagong Medical College and Hospital
Chattogram, Bangladesh
 CMC Ethical Review Committee
Chittagong Medical College
Chattogram-4000, Bangladesh
Tel-031619400, Fax-630180

Application for Ethical Clearance of Studies for post-Graduate Thesis

1. Name of the applicant : DR. Sharmin Akter

2. Course : MD (Internal Medicine Phase B)

3. Category : Government

4. Title of the study : Microalbuminuria as a Prognostic Marker in

Patients with Acute Ischemic Stroke admitted

to a Tertiary Hospital in Bangladesh

5. Type of the study : Prospective observational study

6. Duration of the study : One year

7. Any collaboration : No

8. Conflict of interest : None

9. Name of the Guide : Dr. Shoman Sarker, Associate Professor,

Professor & Head, Department of Medicine,

Chittagong Medical College and Hospital,

Chattogram, Bangladesh

10. Name of the Co-Guide : Dr. Rabiul Alom, Assistant Professor,

Department of Medicine, Chittagong Medical

College and Hospital, Chattogram, Bangladesh

Check Documents being submitted herewith to committee:

1. Summary : Attached

2. Umbrella proposal initially : NA

3. Protocol and CRF : Attached

4. Informed consent form for subject : Attached

5. Verbal consent form for subjects : NA

6. Procedure for Maintaining Confidentiality : Attached

7. Schedule of the study : Attached

 Declaration

I agree to obtain approval of the Ethical Review Committee for any changes involving the

rights and welfare of subjects or any changes of the methodology before making any such

changes.

…………………………………
Principal investigator/Student

DR. Sharmin Akter

MD (Internal Medicine-Phase B)
Department of Medicine
Chittagong Medical College and Hospital
Chattogram, Bangladesh

Forwarded by

………………………………
Guide

Dr. Shoman Sarker, Associate Professor,

Department of Medicine,
Chittagong Medical College and Hospital,
Chattogram, Bangladesh
 CHITTAGONG MEDICAL COLLEGE
Application for the Ethical review of thesis protocol

1. Name of the applicant : DR. Sharmin Akter

2. Course : MD (Internal Medicine Phase B)
3. Category : Government
4. Title of the study : Microalbuminuria as a Prognostic Marker in
Patients with Acute Ischemic Stroke admitted
to a Tertiary Hospital in Bangladesh
5. Type of the study : Hospital based prospective observational study
6. Duration of the study : One year
7. Any collaboration : No
8. Conflict of interest : None
9. Name of the Guide : Dr. Shoman Sarker, Associate Professor,
Department of Medicine,
Chittagong Medical College and Hospital,
Chattogram, Bangladesh
10. Name of the Co-Guide : Dr. Rabiul Alom, Assistant Professor
11. Signature of the Guide :
12. Signature of the Co-Guide :
13. Submission date :
14. Signature of the Student :

For Official use:

Serial No: Received on: Reviewed on:
Comment:

Member-Secretary ERB Chairperson ERB

 Circle the appropriate answer to each of the following.
(If not Applicable write NA)
1. Source Population: 4. Are subjects clearly informed about:
(a) Ill Subjects Yes No (a) Nature and purpose Yes No
of the study
(b) Non* ill subjects Yes No (b) Procedures to be Yes No
followed including
alternatives used
(c) Minors or persons under Yes No (c) Physical risks Yes No
guardianship
(d) Private questions Yes No
2. Does the study involve: (e) Invasion of the Body Yes No
(a) Physical risks to subjects Yes No (f) Benefits to be Yes No
Derived
(b) Social risks Yes No (g) Right to refuse to Yes No
participate or
withdraw from the study
(c) Psychological risks to Yes No (h) Confidential handling Yes No
subjects of data
(d) Discomfort to Yes No (i) Compensation where Yes No
Subjects there are risks or loss of
(e) Invasion of the body Yes No working time or privacy
(f) Invasion of privacy Yes No is involved in any
particular procedure
(g) Disclosure of information Yes No
damaging to subject or others
(a) From subject Yes No
(b) From parent or Yes No
Guardians
3. Does the study involve:
(a) Use of records (hospital, Yes No 6. Will precautions will Yes No
medical, death, birth or be taken to protect
other) anonymity of subjects
(b) Use of fetal tissue or Yes No
abortus
(c) Use of organs or body Yes No
fluids
 Chittagong Medical College
Chattogram-4000, Bangladesh
Tel-031619400, Fax-630180
Research Proposal
For Post Graduate Thesis/Dissertation
Part - A

1. Title of the study : Microalbuminuria as a Prognostic Marker in

Patients with Acute Ischemic Stroke admitted to
a Tertiary Hospital in Bangladesh
2. Name of the applicant : DR. Sharmin Akter
3. Course : MD (Internal Medicine Phase B)
4. Place of Study : Department of Medicine, Chittagong Medical
College Hospital, Chattogram.
5. Sponsoring : Not Applicable
6. Duration of the study : One year
7. Date of Commencement :
8. Date of completion
9. Total cost :
10. Other support of proposed research
i. : In this research project being supported by any other source? No
ii. Has an application for funding of this project has been submitted to any other No
organization (s)?
11. Date of submission :
12. Signature of student :
13. Signature of Guide :
14. Endorsement of the course coordinator
Name and Signature
Designation
Official Seal
 Part – B
Student’s Information Sheet
1. Name : DR. Sharmin Akter
Designation : Student, MD (Internal Medicine Phase B)
Official address with telephone & mail : Department of Medicine, Chittagong
Medical College Hospital, Chattogram
Phone: 01552674054
Email: @gmail.com
Present residential address :
2. Academic Background :
Degree Institute University/Board Field Year
M.B.B.S Passed

3. Field of study : Internal Medicine

4. Research experience : None
5. Percentage of time to be devoted to this : 100%
project
6. Number of Scientific Publication : None

…………………………..
Signature of the Student
 PART-C

Title: Microalbuminuria as a Prognostic Marker in Patients with Acute Ischemic

Stroke admitted to a Tertiary Hospital in Bangladesh
Summary

Background: Microalbuminuria is associated with clinical risk factors for stroke,

including diabetes, hypertension, aging, history of myocardial infarction, and left
ventricular hypertrophy, there is little information regarding it as a predictor of stroke
outcome. Aims: This study aims to find out the value of microalbuminuria as a
prognostic marker in adult patients presented with acute ischemic stroke in a tertiary
hospital, Chattogram, Bangladesh. Materials and Methods: The proposed hospital-
based prospective observational study will be conducted in the Department of
Medicine of Chittagong Medical College Hospital from March 2023 to February
2023. Patients older than 18 who presented with acute ischemic stroke within 24
hours of their symptom onset will be screened from the medicine and neurology ward.
Blood and urine samples will be collected to estimate albumin creatinine level. The
severity of the stroke will be assessed by NIHS Scale. The patient will be followed up
clinically to record the severity of the stroke and the deterioration of clinical
parameters during hospital stay. On the 90th day, a visit by the patient to the follow-
up clinic or research physician will visit the patient to document the patient’s outcome
with a modified Rankin score. Patient outcomes will be dichotomized into good (mRS
score, 0–3) and poor (mRS score, 4–6) categories based on functional status. Different
variables including microalbuminuria will be between patients having good and poor
outcome. Data will be analyzed using SPSS version-
23. Discussion: Microalbuminuria and stroke have closely similar underlying
pathophysiologic processes (e.g., generalized endothelial dysfunction). So,
microalbuminuria could serve as a useful, easily measured, and inexpensive marker of
outcome in stroke patients.
 PART-D
1. Introduction:

Globally, stroke remains the second-leading cause of death and the third-leading
cause of death and disability combined. From 1990 to 2019, the burden increased
substantially (70.0% increase in incident strokes, 43.0% deaths from stroke, 102.0%
prevalent strokes, and 143.0% DALYs), with the bulk of the global stroke burden
(86.0% of deaths and 89.0% of DALYs) residing in lower-income and lower-middle-
income countries (LMIC) (Feigin et al., 2022). According to the latest WHO data
published in 2020 Stroke Deaths in Bangladesh reached 134,166 or 18.74% of total
deaths (World Health Ranking 2020) keeping it at the top of the list of ‘leading causes
of death in Bangladesh’. A recent prevalence survey on stroke conducted throughout
the Bangladesh from a representative sample of the population revealed a high burden
of stroke with an overall prevalence of 11.39 per 1000 adult population, which is
higher than other LIMCs (5.36 to 10.40 per thousand) (Mondal et al., 2022). Stroke is
the most common condition among neurology in-patients (48%) and out-patients
(24%) of Bangladesh (Chowdhury et al., 2014; Uddin et al., 2018).  It places a
tremendous burden on health resources in Bangladesh. Timely intervention can
dramatically improve outcome and reduce disability.

One third of ischemic stroke patients will die within some months after the stroke or
its complications. Approximately half of ischemic stroke survivors remain disabled,
and 20% require institutionalization (Benjamin et al. 2018; Kim et al. 2020).
Exploring the key prognostic factors is crucial for clinicians to design the treatments
accordingly and improve the clinical outcomes of stroke patients. The baseline
ischemic stroke severity as measured using the National Institutes of Health Stroke
Scale (NIHSS) (Brott et al. 1989) and disability as measured using the modified
Rankin score (mRS) (Van Swieten et al., 1988) have been used as clinical predictors
of ischemic stroke outcome. NIHSS scores were more useful in predicting functional
short-term outcome after ischemic stroke onset than laboratory biomarkers reflecting
different pathophysiological mechanisms involved in ischemic stroke (Ozkan et al.
2013).
Over the last 4 decades, several prospective clinical studies have identified a series of
independent risk factors for stroke. One such emerging vascular risk factor is
microalbuminuria (Lee et al., 2010). The term “microalbuminuria” denotes an
increase in albumin excretion that remains below the lower limits of sensitivity for
routine diagnostic methods and defined as a urine albumin:creatinine ratio (ACR)
within the specific range of 30–300 mg/g (Viberti et al., 1982). Microalbuminuria was
originally introduced to clinical practice as a marker for incipient diabetic
nephropathy. In the past decade the role of microalbuminuria has become apparent in
acute diseases such as myocardial infarction and stroke (Rocco et al., 2010).

In acute stroke patients, microalbuminuria was associated with severe neurological

deficit upon admission and severe functional impairment upon discharge, and
microalbuminuria was shown to be an independent predictor of poor outcome
(Gumbinger et a., 2012). Cho et al. (2012) observed that, in the early phase of
ischaemic stroke, patients with microalbuminuria were associated with worse clinical
and radiological outcomes than those without. Recent studies showed that
microalbuminuria was significantly associated with early neurological deterioration in
patients with acute small subcortical infarcts in the lenticulostriate artery territory
(Umemura et al., 2014). A highly significant association between microalbuminuria
and ischemic stroke has been reported by Elyas et al. (2016), who reported that
microalbuminuria was higher in patients at high risk for recurrence, independent of
other important risk factors, such as age, sex, blood pressure, diabetes, and previous
stroke (Elyas et al., 2016). In a large Chinese population, persistent albuminuria was
independently associated with 1-year all-cause death, stroke recurrence, and poor
functional outcome (Wang et al., 2022).

However, the association between microalbuminuria and the severity of ischemic

stroke or a prognostic marker for stroke outcome has not been systematically
investigated in Bangladeshi population. Chowdhury et al. (2012) reported a higher 14-
days mortality rate in ischemic stroke patients with microalbuminuria (26.7% vs.
11.7%) than in patients without microalbuminuria. However, the study did not
consider the effect of other important covariate on the mortality and the functional
outcome after acute stroke. In this study, therefore, I plan to systematically explore
the prevalence of microalbuminuria in ischemic stroke patients, and the association of
microalbuminuria with the severity of ischemic stroke, and the prognostic value of
microalbuminuria in acute ischemic stroke patients admitted to a tertiary hospital in
Bangladesh.
2. Rationale:

Microalbuminuria in patients with diabetes is related to the disturbance of coagulation

and fibrinolysis, with increases in plasminogen activator inhibitor-1 and thrombin-
activatable fibrinolysis inhibitor (Chudý et al., 2011). Thrombin-activatable
fibrinolysis inhibitor attenuates fibrinolysis and therefore contributes to the
pathophysiology of arterial thrombosis (De Bruijne et al., 2009). Endothelial
dysfunction is present in patients with microalbuminuria, and this process is
associated with the loss of heparan sulphate from the extracellular matrix and plasma
membrane, which leads to increased permeability of the vascular membrane (Blanco
et al., 2005). Thus, lesion growth and hemorrhagic transformation may be closely
related to endothelial dysfunction and the disturbance of fibrinolysis due to
microalbuminuria in ischemic stroke patients.

Ischemic stroke results in increased medical resource use, causing a considerable

economic impact. Therefore, timely clinical outcome evaluation is essential for
appropriate medical resource allocation. Estimation of urinary ACR on a spot urine
sample considered to be a simple and easy method to detect microalbuminuria. It is a
noninvasive, cost effective and less time-consuming test. If the present study could
confirm the prognostic utility of microalbuminuria in predicting outcome of the
patients with acute ischemic stroke, then measurement of microalbuminuria may thus
help to assess those who are at increased risk and to triage those who may need a
more aggressive management protocol.
3. Research question/Hypothesis:

3.1 Research question: Does microalbuminuria has any prognostic utility for the
prediction of outcome among patients with ischemic stroke admitted to a tertiary-
level hospital in Bangladesh?

3.2 Research hypothesis: Microalbuminuria is associated with worse clinical

outcomes among patients with ischemic stroke admitted to a tertiary-level hospital
in Bangladesh?.

4. Objectives:

4.1. General objective:

 To investigate the prognostic value of microalbuminuria in patients
presented with acute ischemic stroke to a tertiary hospital in Bangladesh.
4.2 Specific objectives:
1. To find out the percentage of patients with acute ischemic stroke having
albuminuria,
2. To detect the association of Microalbuminuria with severity of ischemic
stroke,
3. To follow the patients at 90th day to asses outcome measures in terms of
disability and mortality
4. To compare the early clinical outcome (during discharge and after 90
days) in patients having acute ischemic stroke with and without
Microalbuminuria,
5. To determine whether Microalbuminuria is an independent predictor of
early poor outcome,
1)
5. Materials and method:

5.1. Type of study: A hospital based prospective observational study.

5.2 Place of Study: Department of Medicine and Department of Neurology,

Chattogram Medical College Hospital, Chattogram, Bangladesh.

5.3. Study period: One year from acceptance of protocol.

5.4. Study population: Adult patients admitted to this hospital with a diagnosis of
ischemic stroke during the study period.

5.5. Sample Technique: Consecutive sampling.

5.6. Sample size: Sample size is calculated by using the following formula:
5.7. Selection criteria:

5.7.1 Inclusion criteria:

1. Patients admitted with first ever ischemic stroke within 24 hours after
onset of symptoms.
2. Age ≥ 18 years
5.7.2 Exclusion criteria:
1. Patients having pyouria on Urine R/E.
2. Patients having diseases influencing urinary protein excretion such
as CCF, GN, NS, SLE.
3. Diagnosed cases of CKD.
5.8. List of variables:

 Demographic variables: Age, Gender.

 Risk factors of stroke: Smoking, hypertension, diabetes, dyslipidemia,
ischemic heart disease, atrial fibrillation, obesity.
 Clinical presentation: Body mass index, waist circumference, NIHSS score
 Biochemical variables: CBC, RBS, Urine R/E, Lipid Profile, ECG, ACR
 Radiological findings: CT scan of Brain
 Outcome variables: mRS score.

5.9. Operational definitions:

Ischemic stroke: In the study ischemic stroke will be defined as the cases having
radiological findings of ischemia on CT scan of brain.

Hypertension: Patients will be labeled as hypertensive if systolic blood pressure was

greater than 140 mmHg or/and diastolic blood pressure will be greater than 90 mmHg
during repeated measurements during the patient management in the hospital or if the
patient will be on antihypertensive drugs at the time of admission.

Diabetes: Patient will be labeled as diabetic if self-reported fasting glucose level of

the patient will be 120 mg/dL or more or if the patient will be on hypoglycemic agents
or insulin.
Dyslipidemia: Patients having serum high density lipid of 40 mg/dL or less and/or
serum low density lipid of 100 mg/dL or more and/or fasting serum cholesterol of 200
mg/dL or more will be labeled as having dyslipidemia.

Smoking: Smoking history is defined by the World Health Organization (WHO) in

1997 as those who had smoked for at least 6 months or had smoked at least 100
cigarettes in their lifetime (Bondy et al., 2009).

Albuminuria: UACR values < 30 mg/gm will be defined as normoalbuminuric,

values between 30 and 299 mg/gm will be defined as microalbuminuria, and values
≥300 mg/gm will be considered as macroalbuminuria (Levey et al., 2002).

Functional outcome at discharge and at 90 days: Based on mRS score, good

Functional outcome (mRS score 0–3 points) and poor Functional outcome (mRS
score 4–6 points) (Gupta et al., 2017; Li et al., 2019).

5.10 Data collection instrument: A structured questionnaire will be used to collect

information on demographic variables, stroke severity (with the help of mRS and
NIHSS), stroke subtype using TOAST criteria, vascular risk factors, and biochemical
parameters.

5.11 Data collection procedure:

Consecutive patients of stroke admitted in Neurology ward of CMCH will be

screened to identify an eligible patient. Written consent will be obtained from the
patients or their next of kin in case of incapacitation of the patients. On admission a
detailed history with a special emphasis on hypertension will be recorded. Presence of
other risk factors like smoking, diabetes mellitus, coronary artery disease, atrial
fibrillation and dyslipidemia will be also evaluated. General physical and neurological
examination will be carried out in all patients to diagnose and find possible
underlying risk factors of stroke. Medical and laboratory reports will be reviewed
during hospital stay. Patients will be observed till their discharge to record outcome
and complications.
Blood and urine samples will be collected to evaluate albumin creatinine level, which
indicates albuminuria. Albuminuria assessment based on random morning spot urine
collection in the fasting state on the first morning after admission. Urinary albumin
will be measured immediately after collection using the turbidimetric immunoassay
method (Olympus AU 5431, Tokyo, Japan; Toshiba TBA-200FR autoanalyzer,
Tokyo, Japan); serum and urinary creatinine will be measured using the Jaffe method.
Urinary albumin excretion will be estimated as the UACR in mg albumin/per g
creatinine. This method, based on spot urine, yields results comparable to those from
a 24 h urine collection.

The severity of the stroke will be assessed by NIHS Scale. The patient will be
followed up clinically during hospital stay days. Clinical follow-up will be given to
record the severity of the stroke and the deterioration of clinical parameters.
Immediate hospital outcomes will be recorded on the day of discharge. On the 90th
day, a visit by the patient to the follow-up clinic or research physician will visit the
patient to document the patient’s outcome with a mRS.

5.12. Data analysis:

Data will be recorded in the form of Excel worksheet. After completion of data

collection, they will be fed into SPSS for processing analysis. Continuous data will be
expressed as mean ± standard deviation (SD) for normally distributed data or median
and 25%–75% interquartile range for non-normally distributed data. Categorical
variables will be presented as frequency (percentages) or proportions. Study
population will be divided into good and poor outcome groups. Between these groups,
continuous and categorical variables will be analyzed. Student's t-test will be used to
analyze normally distributed continuous variables, while Mann–Whitney U-test will
be used for non-normally distributed continuous variables. Categorical variables will
be compared by means of Chi-square test. Correlations will be determined using
Pearson or Spearman correlation. Multivariate analysis will be performed by binary
logistic regression analysis, which allows adjustment for confounding factors (age, the
NIHSS score, infarct volume, stroke syndrome, vascular risk factors, and other
laboratory biomarkers). Results will be expressed as adjusted odds ratios (OR) with
the corresponding 95% confidence intervals (CIs). Receiver operating characteristic
(ROC) curves will be utilized to evaluate the accuracy of microalbuminuria to predict
outcomes. All statistical analysis will be performed with SPSS for Windows, version
26.0 (SPSS IBM, USA). Statistical significance will be defined as p<0.05.

6. Utilization of result: The results of the study would be utilized for the clinical
decision making for the hospitalized patients with acute ischemic stroke. Based on the
study findings, future interventional study could be conducted at the study site.
Overall, the study results would increase the awareness of the clinicians of
Bangladesh for If predictors of early outcomes can be recognized and appropriately
managed, initial worsening can be prevented, and long-term outcome improved. That
will surely reduce the huge burden of disability due to ischemic stroke.

7. Dissemination:

 The study will be submitted to respective University as part of the

requirement for the MD (Internal Medicine) examination purpose.
 The results of the study will be presented to the Department of Medicine,
CMCH.
 Effort will also be made to present these results at conferences and publish
them in peer review journals.

8. Ethical Implication: Ethical approval will be obtained from the Ethical Review
Committee of CMC, and permission will be obtained from the hospital administrator
before dat6a collection. As pe the ethical guideline voluntary written consent will be
taken from patient or from the caregivers. All measures will be taken to protect the
anonymity. No compensation will be given to the subject as data will be collected in
the hospital where they have admitted for their own interest. The study does not
involve the testing of new drugs, placebo or use of organs, the fetus. Patient can
withdraw himself from the study at any time. Refusal to participate or withdrawal will
not have any impact on their management in the hospital.
10. Flow Chart showing sequence of task:

Patient admitted with ischemic stroke will be assessed for eligibility

↓
Having exclusion criteria yeswill exclude from study
↓ No
Imaging findings support strokeNowill exclude from study
↓ (Yes)
Consent given No exclude
↓yes
History, Physical examinations will be recorded in CRF
↓
Follow-up till 90 days from enrollment to observe outcome.
↓
Data Analysis
↓
Result and discussion writing
↓
Presentation of thesis in the department
↓
Will be submitted to the university
Timetable (Gannt chart) chart:
Task Months
1 2 3 4 5 6 7 8 9 10 11 12
1 Protocol
preparation
2 Organizing
the
materials
3 Data
collection
4 Interim
analysis
5 Final
analysis
2 Thesis
writing &
submission
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stratification. American Journal of Kidney Diseases, 39(2 SUPPL. 1), pp.S1-266.

Rocco, A., Heerlein, K., Diedler, J., Sykora, M., Barrows, R., Hacke, W. and Steiner,
T., 2010. Microalbuminuria in cerebrovascular disease: a modifiable risk
factor?. International Journal of Stroke, 5(1), pp.30-34.

Thampy, A. and Pais, C.C., 2016. Early clinical implications of microalbuminuria in

patients with acute ischaemic stroke. Journal of clinical and diagnostic research:
JCDR, 10(9), p.OC29.

Uddin, M.S., Al Mamun, A., Asaduzzaman, M.D., Hosn, F., Sufian, M.A., Takeda,
S., Herrera-Calderon, O., Abdel-Daim, M.M., Uddin, G.S., Noor, M.A.A. and Begum,
M.M., 2018. Spectrum of disease and prescription pattern for outpatients with
neurological disorders: an empirical pilot study in Bangladesh. Annals of
Neurosciences, 25(1), pp.25-37.

Umemura, T., Senda, J., Fukami, Y., Mashita, S., Kawamura, T., Sakakibara, T. and
Sobue, G., 2014. Impact of albuminuria on early neurological deterioration and lesion
volume expansion in lenticulostriate small infarcts. Stroke, 45(2), pp.587-590.

Van Swieten, J.C., Koudstaal, P.J., Visser, M.C., Schouten, H.J. and Van Gijn, J.,
1988. Interobserver agreement for the assessment of handicap in stroke
patients. stroke, 19(5), pp.604-607.

Viberti, G.C., Jarrett, R.J. and Keen, H., 1982. Microalbuminuria as prediction of
nephropathy in diabetics. Lancet (London, England), 2(8298), pp.611-611.

Wang, D., Pan, Y., Li, H., Yan, H., Meng, X., Lin, J., Wang, H., Matsushita, K.,
Shlipak, M.G., Zhou, Y. and Wang, Y., 2022. The Association between Baseline and
3-Month Albuminuria and 1-Year Prognosis of Ischemic Stroke. Cerebrovascular
Diseases, 51(1), pp.67-74.

World Health Rankings. 2018, (Online) Retrieved on June 01, 2020, from:
https://www.worldlife expectancy.com/ bangladesh-stroke.
 Part E
Budget:
Sl. No. Head of expense
1st instalment
1 Research tools development 10,000/-
2 Office assistance for organizing the 5,000/-
materials
Data collection ----
3 Data analysis ----
4 Report composing 30,000/-
5 Printing 5,000/-
6 Stationaries 5,000/-
7 Transport/conveyance -----
8 Miscellaneous -----
Total amount
Appendix-A

Case record form

Protocol Title: “Microalbuminuria as a Prognostic Marker in Patients with

Acute Ischemic Stroke admitted to a Tertiary Hospital in Bangladesh”

A Identification
1 ID no.
5 Contact number

B Demographic information
1 Age …yrs
2 Sex Male=1 Female=2

C Risk factors
1 Smoking
2 Alcohol consumption
3 Hypertension
4 Diabetes
5 Ischemic heart diseases
6 Dyslipidemia
7 Atrial fibrillation
8 Generalized Obesity
9 Abdominal obesity
10 Waist circumference
Never=0 Ex=1 Current=3
Never=0 Ex=1 Current=3
Absent=0 Newly diagnosed=1 Previously
diagnosed=2
Absent=0 Newly diagnosed=1 Previously
diagnosed=2
Absent=0 Newly diagnosed=1 Previously
diagnosed=2
Absent=0 Newly diagnosed=1 Previously
diagnosed=2
Absent=0 Newly diagnosed=1 Previously
diagnosed=2
Absent=0 Present=1 (BMI >25.0kgm2
Absent=0 Present=1 (WtHtR=>0.5)
cm

D Clinical presentation at admission

1 Blood pressure
2 NIHSS score
3 TOAST category Large vessel=1 Small vessel=2
Cardioembolic=3 Unknown etiology=4
4

E Investigations findings
1 Hemoglobin ….mg/dl
2 RBS …..mg/dl
3 Serum creatinine ……mg/dl
4 Lipid profile TC= TG= LDL= HDL=
5 ECG
6 Echocardiography
7 Urinary ACR
8
 G Stroke outcome
1 Length of stay in hospital …day
2 In hospital mortality No=0 Yes=1
3 MRS at discharge
4 90-day mortality No=0 Yes=1
5 MRS at 90-day

NIHSS score at the time of presentation:

Instruction Scale definition Score
1a. Level of consciousness (LOC)
0= Alert, keenly responsive
The investigator must choose a response if a
full evaluation is prevented by such obstacles 1= Not alert; but arousable by minor
as an endotracheal tube, language barrier, stimulation
orotracheal trauma/bandages. A 3 is scored 2= Not alert; require repeated stimulation to
only if the patient makes no movement (other attend
than reflexive posturing) in response to 3= Totally unresponsive or response only
noxious stimulation. with reflex motor or autonomic effects
1b. LOC Questions
0= Answer both questions correctly
The patient is asked the month and his/her
age. The answer must be correct - there is no 1= Answer one question correctly
partial credit for being close. Aphasic and 2= Answer neither question correctly
stuporous patients who do not comprehend
the questions will score 2.
1c. LOC Commands
0= Perform both tasks correctly
The patient is asked to open and close the
eyes and then to grip and release the non- 1= Perform one task correctly
paretic hand. 2= Perform neither task correctly
2. Best Gaze
0= Normal
Only horizontal eye movements will be
tested. Voluntary or reflexive (oculocephalic) 1= Partial Gaze palsy
eye movements will be scored, but caloric 2= Forced deviation
testing is not done.
3. Visual
Visual fields (upper and lower quadrants) are 0= No visual
tested by confrontation, using finger counting or 1= Partial Hemianopia
visual threat, as appropriate. Patients may be 2= Complete Hemianopia
encouraged, but if they look at the side of the 3= Bilateral hemianopia
moving fingers appropriately, this can be scored
as normal.

4. Facial palsy
0= Normal
Ask – or use pantomime to encourage – the
patient to show teeth or raise eyebrows and close 1= Minor paralysis
eyes. Score symmetry of grimace in response to 2= Partial paralysis
noxious stimuli in the poorly responsive or non- 3= Complete paralysis
comprehending patient.

5. Motor Arm
0= No drift
The limb is placed in the appropriate position:
extend the arms (palms down) 90 degrees (if 1= Drift
sitting) or 45 degrees (if supine). Drift is scored 2= Some effort against gravity
if the arm falls before 10 seconds. The aphasic 3= No effort against gravity
patient is encouraged using urgency in the voice 4= No movement
and pantomime, but not noxious stimulation. UN Amputation
Each limb is tested in turn, beginning with the 5a. Left arm
non-paretic arm. 5b. Right arm
6. Motor Leg
0= No drift
The limb is placed in the appropriate position:
hold the leg at 30 degrees (always tested supine). 1= Drift
Drift is scored if the leg falls before 5 seconds. 2= Some effort against gravity
The aphasic patient is encouraged using urgency 3= No effort against gravity
in the voice and pantomime, but not noxious 4= No movement
stimulation. Each limb is tested in turn, UN Amputation
beginning with the non-paretic leg. 5a. Left leg
5b. Right leg
7. Limb atxia
0= Absent
Test with eyes open. The finger-nose-finger and
heel-shin tests are performed on both sides, and 1= Present in one limb
ataxia is scored only if present out of proportion 2= Present in two limbs
to weakness. Ataxia is absent in the patient who UN Amputation
cannot understand or is paralyzed.
8. Sensory
0= Normal, no sensory loss
Sensation or grimace to pinprick when tested, or
withdrawal from noxious stimulus in the 1= Mild to moderate sensory loss
obtunded or aphasic patient. 2= Moderate ot severe sensory loss

9. Best language
0= No aphasia, normal
The patient is asked to describe what is
happening in the attached picture, to name the 1= Mild to moderate aphasia
items on the attached naming sheet and to read 2= Severe aphasia
from the attached list of sentences. 3= Mute or global aphasia

10. Dysarthria
0= Normal, no dysarthria
If patient is thought to be normal, an adequate
sample of speech must be obtained by asking 1= Mild to moderate dysarthria
patient to read or repeat words from the attached 2= Severe dysarthria
list.
11. Extinction and inattention
0= No abnormality
Sufficient information to identify neglect may be
obtained during the prior testing. 1= Visual, tactile, auditory or spatial
2= Profound hemi-inattention
Total:
Appendix B (i)

তথ্য বিবরণী

গবেষণার শিরোনাম: “বাংলাদেশের একটি টারশিয়ারি হাসপাতালে ভর্তি একিউট ইস্কেমিক স্ট্রোকের রোগীদের মধ্যে একটি
প্রগনোস্টিক মার্কার হিসাবে মাইক্রোঅ্যালবুমিনুরিয়ার ভূ মিকা মূল্যায়ন।”

আমি, ডাঃ শারমিন আক্তার, এমডি (ফেজ বি)রেসিডেন্ট, মেডিসিন বিভাগ, চট্টগ্রাম মেডিকেল কলেজ হাসপাতাল,
আপনাকে বা আপনার রোগীকে একটি গবেষণায় অংশগ্রহণের জন্য আমন্ত্রণ জানাচ্ছি । এই গবেষণাটি চট্টগ্রাম মেডিকেল
কলেজ হাসপাতালে ভর্তি হওয়া স্ট্রোক এ আক্রান্ত রোগীদের খারাপ ফলাফলের ভবিষ্যদ্বাণীর মূল্যায়ন করার জন্য তাদের
প্রস্রাবে নির্গত এলবুমিনের কোন ভূ মিকা আছে কিন-না তা খুঁজে বের করার চেষ্টা করবে। এখন, আমি আপনাকে
বিস্তারিতভাবে গবেষণার উদ্দেশ্য এবং পদ্ধতি বর্ণনা করতে যাচ্ছি । গবেষণা সম্পর্কে আপনার যদি কোন প্রশ্ন থাকে তা
নির্দ্বিধায় আমার সাথে আলোচনা করুন।

কেন আমরা এই গবেষণা করছি? স্ট্রোক একটি অত্যন্ত মারাত্মক রোগ. এ রোগে তাৎক্ষণিক মৃত্যু ছাড়াও, বেঁচে থাকা
রুগীদের নানা রকম অসমর্থতা নিয়ে বেঁচে থাকতে হয়. অনে ক রোগী আক্রান্ত হওয়ার কিছু সময় পর বেশি খারাপ হয়ে যায়.
এ রোক অবস্থাগুলি সম্পর্কে যদি পূর্বে ধারণা পাওয়া যায়, তবে যথোপুযুক্ত ব্যবস্থা গ্রহণের মাধ্যমে রুগীর অবস্থার উন্নতি
ঘটানো সম্ভব। এ গবেষণায় আমরা এ ক্ষেত্রে প্রস্রাবে নির্গত এলবুমিনের কোন উপযোগিতা আছে কিন-না তা খুঁজে বের
করার চেষ্টা করবে।

কেন আমাকে অংশ নিতে বলা হচ্ছে? আপনি বা আপনার রোগী স্ট্রোক রোগে আক্রান্ত। আমরা এ রকম প্রায় ১০০ জন
রোগীর উপর এই গবেষণা করছি।

অংশগ্রহণ স্বেচ্ছায়: আমাকে কি অংশ নিতে হবে?

আপনি যদি না চান তবে আপনাকে অংশ নিতে হবে না। গবেষণা শুরু হওয়ার পরে আপনি অংশগ্রহণ না করার বা
প্রত্যাহার না করার সিদ্ধান্ত নিতে পারেন। আপনি কোন কারণ ছাড়া যে কোন সময় প্রত্যাহার করতে পারেন. এটি আপনার
বা আপনার রুগীর চিকিৎসাকে প্রভাবিত করবে না।

গবেষণায় অংশ নিতে আমার কি কিছু খরচ হবে? এই গবেষণায় অংশগ্রহণের জন্য আপনাকে কোনো অর্থ ব্যয় করতে হবে
না। এই গবেষণায় অংশ নেওয়ার জন্য আপনাকে কোনো অর্থপ্রদান করা হবে না।

তথ্যের অধিকার: আমার কোন প্রশ্ন থাকলে আমি কি করতে পারি? এই তথ্য পত্রটি পড়ার পরে যদি আপনার কোন প্রশ্ন
থাকে, তাহলে অংশগ্রহণ করবেন কি না তা সিদ্ধান্ত নেওয়ার আগে আপনি আমার গাইড বা আমার সাথে আলোচনা করার
সুযোগ পাবেন। গবেষণা চলাকালীন সময়ে, আমরা যেকোনো প্রশ্নের উত্তর দিতেও বাধ্য থাকব।

আমি অংশ নিলে কি হবে? আপনি যদি সিদ্ধান্ত নেন যে আপনি অংশগ্রহণ করবেন, তাহলে গবেষণা সম্পর্কে আপনার
যেকোন অতিরিক্ত প্রশ্ন থাকতে পারে তা আমি ব্যাখ্যা করব এবং আপনাকে সম্মতি ফর্মটি পূরণ করতে বলা হবে। আপনি
যদি অংশ নিতে সম্মত হন, আমি আপনাকে কিছু প্রশ্ন জিজ্ঞাসা করব, কিছু শারীরিক পরীক্ষা করব, এবং পরীক্ষা করার
জন্য আপনার রক্ত ও প্রস্রাব সংগ্রহ করব. আমি আপনার রোগ এবং চিকিত্সা সংক্রান্ত সমস্ত তথ্য সংগ্রহ করব এবং
হাসপাতালে থাকাকালীন সময়ে আপনার অবস্থার পরিবির্ত ন লিপিবদ্ধ করব. আপনার রোগের ৯০ দিন অতিক্রান্ত হলে
আমি আপনার শারীরিক অবস্থা পুনরায় পরীক্ষা করে দেখব। হাসপাতালের প্রটোকল এবং সংশ্লিষ্ট চিকিৎসকদের সিদ্ধান্ত
অনুযায়ী আপনার চিকিৎসা চলবে। আমি শুধুমাত্র আপনাকে পর্যবেক্ষণ করব।

নিরাপত্তা: অংশ নেওয়া কি আমার জন্য ক্ষতিকর বা বিপজ্জনক? গবেষণা কাজে অংশ নেওয়ার কোন বিপদ নেই। আপনি
অংশ নিলে, আপনার চিকিত্সার পদ্ধতি পরিবর্ত ন করা হবে না।

সুবিধা: এই গবেষণায় অংশ নেওয়ার সুবিধা কী? আপনি যদি সিদ্ধান্ত নেন যে আপনি অংশ নেবেন, তাহলে আপনি সরাসরি
উপকৃ ত নাও হতে পারেন, কিন্তু এই গবেষণাটি ভবিষ্যতের রোগীদের সাহায্য করবে।

গোপনীয়তা: আমার তথ্যের কি হবে? এই গবেষণায় সংগৃহীত তথ্য গবেষক কর্তৃ ক গোপনীয় থাকবে । শুধুমাত্র গবেষণার
ফলাফল উপস্থাপন করা যেতে পারে বা একটি বৈজ্ঞানিক জার্নালে প্রকাশিত হবে।
কোন সমস্যা বা প্রশ্নের ক্ষেত্রে আমি কার সাথে যোগাযোগ করতে পারি?

ডা. সোমেন দাস, সহযোগী অধ্যাপক, মেডিসিন বিভাগ, চট্টগ্রাম মেডিকেল কলেজ হাসপাতাল, চট্টগ্রাম, বাংলাদেশ।
ডাঃ. শারমিন আক্তার, এমডি (ইন্টারনাল মেডিসিন), ফেজ বি, রেসিডেন্সি, চট্টগ্রাম মেডিকেল কলেজ। সেল:
01552674054।
Appendix B (ii)

Information sheet (English version)

Title of the research: “Microalbuminuria as a Prognostic Marker in Patients with
Acute Ischemic Stroke admitted to a Tertiary Hospital in Bangladesh.”

I, Dr. Sharmin Akhtar, MD (Phase B) Resident, Department of Medicine, Chittagong

Medical College Hospital, invite you or your patient to participate in a study. This
study will try to determine whether urinary albumin has any role in predicting the
poor outcomes of stroke patients admitted to Chittagong Medical College Hospital.
Now, I am going to describe to you the objective and methodology of the research in
detail. Feel free to discuss this with me if you have any questions about the research.

Why are we doing this research? Stroke is a highly deadly disease. In addition to
immediate death from this disease, surviving patients have to live with various
disabilities. Many patients become worse after some time of infection. If these
predisposing conditions are known earlier, it is possible to improve the patient's
condition by taking appropriate measures. In this study, we will try to determine
whether albumin excreted in urine is helpful in this case.

You or your patient has had a stroke. We are doing this study on about 100 such
patients. Why am I being asked to participate?

Participation is voluntary: Do I have to participate?

You don't have to participate if you don't want to. You may decide not to participate
or withdraw after the study has begun. You can withdraw at any time without reason.
It will not affect your or your patient's treatment.

There is no cost to you to participate in this study. You will not be paid for
participating in this study. Will it cost me anything to participate in the study?

Right to information: What can I do if I have questions? If you have any questions
after reading this information sheet, you will have the opportunity to discuss them
with my guide or me before deciding whether or not to participate. During the
research, we will also be obliged to answer any questions.

What happens if I participate? If you decide to participate, I will explain any

additional questions you may have about the research, and you will be asked to
complete the consent form. If you agree to participate, I will ask you questions, do
some physical exams, and collect your blood and urine for testing. I will collect all the
information regarding your disease and treatment and record the changes in your
condition during your hospital stay. After 90 days of your illness, I will re-examine
your physical condition. Your treatment will continue per the hospital protocol and
the decision of the concerned doctors. I will only observe you.
Safety: Is it harmful or dangerous for me to participate? There are no risks involved in
participating in research. If you participate, your treatment regimen will not be
changed.

Benefits: What are the benefits of participating in this study? If you decide to
participate, you may not benefit directly, but this research will help future patients.

Privacy: What happens to my information? The information collected in this study

will be kept confidential by the researcher. Only research results can be presented or
published in a scientific journal.

Who can I contact in case of problems or questions?

Dr. Somen Das, Associate Professor, Department of Medicine, Chittagong Medical

College Hospital, Chittagong, Bangladesh. Dr. Sharmin Akhter, MD (Internal
Medicine), Phase B, Residency, Chittagong Medical College. Cell: 01552674054.
Appendix –C(i)
Consent Form

Protocol ID: - -

Title of the research: “বাংলাদেশের একটি টারশিয়ারি হাসপাতালে ভর্তি একিউট ইস্কেমিক স্ট্রোকের রোগীদের মধ্যে একটি
প্রগনোস্টিক মার্কার হিসাবে মাইক্রোঅ্যালবুমিনুরিয়ার ভূ মিকা মূল্যায়ন।.”

Name of the researcher: Dr. Sharmin Akter

Institution: Department of Medicine, Chittagong Medical College Hospital

1. I have explained the research’s purpose, procedures, risks, benefits, and details.
2. I have understood my or my patient’s role in the research.
3. I am informed that we may stop participating in this research at any time we wish without
showing any reason and without losing any of my rights as a patient here.
4. I understand that my personal information and medical records will be kept strictly
confidential and used for research purposes only.
5. I agree that my patient or I will voluntarily participate in the research without any
prejudice.
Date: ID No:

Patient’s name: ………………………………. Relative’s name: …………………

Signature/left thumb impression of the participant Signature/LTI of the guardian

Witness’s name: ………………………………… Researcher’s name: ……………

Signature/left thumb impression of the witness Signature of the investigator

Name and address of the Investigator for any further information on the research-
DR. Sharmin Akter,
MD (Internal Medicine) Student, Phase B, Residency,
Department of Medicine, Chittagong Medical College and Hospital.
Cell: 01552674054
 সম্মতি পত্র

প্রটোকল আইডিঃ - -

গবেষণার বিষয়ঃ “”

গবেষকের নামঃ শারমিন আক্তার , প্রতিষ্ঠান: মেডিসিন বিভাগ, চট্টগ্রাম মেডিকেল কলেজ হাসপাতাল
1. আমাকে গবেষণার উদ্দেশ্য, পদ্ধতি, ঝুঁ কি, সু বিধা এবং বিস্তারিত ব্যাখ্যা করা হয়েছে।
2. আমি গবেষণায় আমার বা আমার রোগীর ভূমিকা বু ঝতে পেরেছি।
3. আমেক জানানো হয়েছে যে, এ গবেষণায় অংশগ্রহণ সম্পূ র্ণ রূপে আমার ইচ্ছার উপর নির্ভ র করবে, এবং একজন রোগী হিসেবে আমার
কোনো অধিকার হারানো ছাড়াই যে কোন সময় গবেষণা থেকে আমাকে বা আমার রুগীকে প্রত্যাহার করে নিতে পারি।
4. আমাকে নিশ্চয়তা দেয়া হয়েছে যে আমার ব্যক্তিগত তথ্য এবং মেডিকেল রেকর্ড গুলি কঠোরভাবে গোপন রাখা হবে এবং শুধু মাত্র গবেষণার
উদ্দেশ্যে ব্যবহার করা হবে৷
5. আমি স্বেচ্ছায় গবেষণায় অংশগ্রহণ করতে বা আমার রুগীকে এ গবেষণায় অন্তর্ভু ক্ত করতে সম্মত আছি।

তারিখঃ আইডি নং

রোগীর নামঃ অংশগ্রহণকারীর অভিভাবকের নামঃ

রোগীর স্বাক্ষর/ বাম বৃদ্ধাঙ্গুলির টিপসই অংশগ্রহণকারীর অভিভাবকের স্বাক্ষর/ বাম

বৃদ্ধাঙ্গুলির টিপসই
সাক্ষীর নামঃ গবেষকের নামঃ

সাক্ষীর স্বাক্ষর/ বাম বৃদ্ধাঙ্গুলির টিপসই গবেষকের স্বাক্ষর

প্রক্রিয়া চলাকালীন সময়ে আপনার যদি কোন প্রশ্ন থাকে, আপনি যেকোন সময় তা জানতে পারেন। আপনার আরও
কিছু জানার থাকলে আপনি নিম্ন লিখিত ডাক্তারের সাথে যোগাযোগ করতে পারেন।

ডাঃ শারমিন আক্তার, ফেজ-বি রেসিডেন্ট, (এমডি -ইন্টারনাল মেডিসিন), মেডিসিন বিভাগ, চট্টগ্রাম মেডিকেল কলেজ
হাসপাতাল. যোগাযোগের নম্বর: ০১৫৫২৬৭৪০৫৪