Does having pre-existing Cardiovascular disease affect the development of Dementia?

Yusneisy Cuellar

HSC 4730: Public Health Research

Professor Lukens Bull

 Abstract
One of the most prominent leading causes of death in the United States is heart disease.

According to the Centers for Disease Control and Prevention (CDC), one person dies every 37

seconds in the United States from cardiovascular disease. As adults become older, there seems to

be a trend of developing cardiovascular disease around the ages of 65-70. A heart attack is

known as a blood clot blocking blood flow to the heart. Not only does having a heart attack

affect the heart, but it can affect the brain as well. Having a heart attack can cause a loss of gray

matter in the brain which then develops a decline in mental processes. A well-known disease that

causes abnormal brain changes is known as Dementia. Dementia is caused by damages to brain

cells. This damage can interfere with the ability of brain cells to communicate with one another.

When a region of the brain is damaged, that the region cannot carry out its function. The

discussion aims to review the research that has been evaluated to analyze how having pre-

determined cardiovascular disease affect a person’s chances of developing Dementia. The

purpose of this study is to seek an understanding of how these two diseases, and their pathologies

can mirror one another to form a correlation.

 Background
Cardiovascular disease and dementia have been commonly seen in the elderly. Research

has shown that nearly half of all adults in the United States have some type of CVD. According

to the American Heart Association, 116.4 million (46%) of adults are estimated on having

hypertension. If the U.S. continues with these rates, by the year 2035, more than 130 million

people are projected on developing some form of Cardiovascular disease. Cardiovascular disease

is a broad term for several types of heart diseases. In this study, researchers have focused on

Myocardial Infarction (or heart attacks; MI ), Coronary Artery Disease (CAD), and Hypertension

(HTN) as forms of CVD.

Myocardial Infarction and Dementia

In 2019, nearly 1.5 million heart attacks have occurred every year in the U.S. A

Myocardial Infarction can create a blockage of blood flow to the heart which prevents the cells

from getting oxygen.. Dr. Bernhard Haring used date involving 6,000 women of the ages of 65 to

79 showed that females who had an MI in the past are twice as likely to have some sort of

decline in their memory and cognitive ability (Go Red for women). In Newman., et al. study

entitled “Dementia and Alzheimer’s Disease incidence in Relationship to Cardiovascular Disease

in the Cardiovascular Health Study Cohort” there seems to be an elevated rate of dementia after

having a Myocardial Infarction during the follow up stage.

Coronary Artery Disease and Dementia

As the aging population is increasing, there seems to be a great deal of cognitive

impairment as well as a high prevalence of CVD. Studies have indicated that CVD and dementia

share a similar genetic makeup and biochemical profile causing there to be some sort of

correlation between the two diseases. (Giacomo., et al. 2020). Both Alzheimers, a form of

Dementia, and Coronary Artery Disease share gene clusters with lipid fractions. One study
showed that out of 17,581 genes, about 39 genes were significant towards both Alzheimer’ s and

CAD (Karlsson., et al. 2017). There has been an increase in CAD incidents. In extreme cases,

CAD has to be fixed with a cardiac procedure called Coronary Artery By-pass Grafting

(CABAG). While this surgery improves the blood flow throughout the arteries, there is 2-13%

percent chance of having a stroke causing some cognitive impairment. One study took

researched six individual studies that related to CAD and dementia. Four out of the six studies

showed the patients having chronic CAD and the outcome shows some cognitive impairment

(Abete., et al. 2014). Other data has shown that CAD interferes with the white matter and gray

matter of the brain causing changes and atrophy.

Hypertension and Dementia

Hypertension can be described as having a systolic blood pressure higher or equal to 160

mmHG. Hypertension in many ways is considered a “silent killer”. Nothing can appear to be

wrong, but over time if left untreated having high blood pressure can cause some significant

damage. As high blood pressure worsens, the formation of LDL (bad cholesterol) forms a plaque

around the artery walls causing atherosclerosis. When the damage increases, it can lead to other

heath conditions, like a stroke. In the Honolulu-Asia Aging Study, having untreated HTN was

associated with developing dementia. The study showed for every 10 mmHg increase in systolic

blood pressure there seemed to be an increase of cognitive impairment of 7% and 9% increase of

poor cognitive function. The researches have hypothesized that the elevation of blood pressure

may affect AB (beta amyloid) clearance and lead to Alzheimer’s Dementia and cerebral amyloid

angiopathy (Muqtadar., et al. 2012).

Pilot Study
In Summer 2020, research was implemented to seek the understanding of older adults

who have an existing history of cardiovascular disease (CVD) can affect the chances of
developing a cognitive impairment such as Dementia. The previous studies have indicated that

there is a correlation between cardiovascular disease and Dementia, however; more research

needs to be executed to determine this statement. An anonymous survey was conducted through

Qualtrics. The participants will be reached out to by flyers in participating stores and publish an

ad on newspapers or television. Once possible participants are interested in taking part of the

research, they will be sent the survey through their email. The survey limits the participation of

those who are 65 years and older, who as some form of CVD and live in Duval County. There

were a total of 20 people who were willing to participate in the survey. Of the responses to the

survey, 40% (8 people) of the participants were between the ages of 71-79 years old now, 25%

(5 people) of the participants were between the ages of 65-70 years old, and finally 20% (4

people) of the participants were 80 years old or older.

Pilot Study Data Analysis

In Figure 1, the data that was collected form the survey shows the percentage of the participants

who responded and are separated by age brackets. Of those who responded (n=20), 31.25% of

the participants were 65 when first diagnosed with Cardiovascular Disease, 12.5% of participants

were 68 and 71 when first diagnosed with Cardiovascular Disease, and 6.25% of participants

were 66, 67, and 75 when first diagnosed with Cardiovascular Disease.
Figure 1

In Figure 2, those who responded (n=20), 25.0% of the participants were either Black or

African American or White, 18.75% of the participants were Asian, and 6.25% of participants

were American Indian or Alaska Native, Native Hawaiian or Pacific Islander, or other. In a

recent study, researchers have discovered that African American adults are 40% more likely to

have a form of cardiovascular disease compared to their non-Hispanic white counterparts. With

this statistic in mind, it is surprising that both races; African American and White were tied at
25%. This issue could be considered a limitation and would need to be taken care of when more

research is done.

Figure 2.

In Figure 3, among the participants; 38% of the participants have had a Myocardial

Infarction, 25% of the participants developed Coronary Artery Disease, and finally 25% of the

participants developed Hypertension.

Figure 3
 Methods
The aim of this study is to show people the effects of having a cardiovascular disease and how it

can have an impact on older adults developing Dementia. To conduct this study there will need

to be a primary analyst who will acquire data throughout the study, with the assistance of

Professor Lukens Bull, MPH and two Medical Doctors who will conduct tests. This study should

ideally include a cardiologist, who will be able to have access to imaging and able to fully

analyze the progression of cardiovascular disease in the participants as well as a neurologist who

will be able to show a development of dementia by using structural imaging like Magnetic

Resonance Imaging (MRI) or Computed Tomography (CT). These images will be useful in the

data collecting and interpretation of Dementia development. Only the essential personnel

involved in this study are allowed access to the records obtained. The participants will be

considered anonymous, and their information will stay classified. Knowing that Dementia affects

the older population, this study will be conducted with those who are 65 years old or older who
live in Duval County, Florida. According to the CDC, by reaching the age of 65, one’s risk of

developing Alzheimer’s disease doubles every five years. In 2013, the American Heart

Association found that about 70.2% of men and 70.9% of women have Cardiovascular Disease

(CVD) between the ages of 60-79. Then would respectfully increase to 83.0% of men and 87.1%

of women; who are 80 years or older (American Heart Association, 2013). With these statistics

in mind , including participants who are of this age range would have a better pool of data to

determine the correlation between both diseases. The participants will be divided into three

groups. One group will be participants who were affected by a heart attack (MI) in the last five

years. The second group will be participants who have been suffering from high blood pressure

in the last five years. Finally, the third group were participants who have never suffered any form

of CVD. The study design of choice is a Retrospective Cohort Study. The study allows

researchers to compare the development of dementia (if any) in patients who have suffered from

a MI or high blood pressure (HTN) throughout the period of five years.

For this study, a total of 3,000 participants will be needed and will be acquired through a

convenience sampling method. The convenience sampling method is used to select participants

who are available and are willing to take impart of the study. Since using a convenience

sampling and only receiving data from those who want to participate can create a volunteer bias.

For example the researchers can receive data from more women than men or receive more

information for a specific demographic and would lack other demographics. To decrease this

from happening the participants; who have finished the survey will receive a $75 gift card as an

incentive. By providing an incentive, it will increase volunteer numbers because receiving

money for any sort of reason will compel anyone to participate. This is an appropriate amount of

money due to the participants taking time out of their day to endure testing to determine specific
factors as well giving consent to the personnel involved in the study to gather the participants

medical records. The participants will be reached out to by flyers in participating stores and

publish an ad on newspapers or television. Once receiving the interest of the participants, a

survey will be sent out to them (whether by mail or email) and this survey will help the primary

analyst obtain data. The purpose of the survey will help the possible participants understand what

will be tested during the study and if they are willing to participate. Here are some of the

questions that will be included in the survey. 1. When they were last tested for CVD 2. Family

history of either dementia or CVD 3. Have they recently had a heart attack (MI) 4. How well

their memory is. Including with their medical records; the participants who will be considered

for the blood pressure group will need to keep a track of their recent BP for 30 days and if they

have any high blood pressures they would need to explain the cause for it and any other

symptoms they have developed. The MI group would need to describe their last heart attack and

how long ago it was. How long after the heart attack did it take them to return to baseline if ever.

With the Institutional Review Board (IRB) system in mind, anyone involved in research

needs to be consented. Once participants are deemed appropriate for the study they will receive a

consent form that needs to be fully read and understood by the participant before continuing on

with the study. To determine if the participant understood the form, they will need to summarize

what was on the form. If the participant is illiterate, a verbal consent is deemed appropriate in

this situation. There would need to be an impartial witness present during the verbalization of the

consent form. Once the verbal consent is done, the participant will also need to summarize what

they were told. With either situation; once the consent is fully understood; they will need to sign

the consent form as well as receive a copy of it.

Research Proposal Data Analysis

The research study entitled “Does having pre-existing Cardiovascular disease affect the

development of Dementia”? will utilize univariate, bivariate, and multivariate analysis. By

utilizing univariate analysis it will examine look at the number of participants affected by

cardiovascular disease. Cardiovascular disease is a broad term for many different heart disease,

by using a univariate approach it can determine which different heart diseases is being displayed

in the sample size and by analyzing the population distribution. Secondly, bivariate analysis

takes into account the relationship between two variables; in this case cardiovascular disease and

dementia. This analysis will examine how specific cardiovascular disease (i.e. nominal variable)

will increase the chances of ‘memory deterioration’ (i.e. outcome variable). Finally this study

will take into account a multivariate form of analyzation. The sample size being used has

different demographics. By using multiple variables; such as work status during diagnosis, race,

and sex; it can help determine several cofactors that increased made the participants get to this

certain point in their lives.

Data Dissemination Plan

After completion of the research, the team will be publishing the findings from the study

in at least one peer reviewed journal. The study team has considered the following journals;

Neurology (American Academy of Neurology), Journal of Epidemiology and Community

Health, and Journal of Cardiovascular Disease Research. The members of the team who have

achieved/working towards a master degree with present the results at the “Ten-Day Seminar on

the Epidemiology and Prevention of Cardiovascular Disease and Stroke 2020; which is being

held in California from July 26th-August 8th. Since the goal of the research is to find if there is a

development of Dementia, the team will present at the “Alzheimer’s Association International

Conference”(AAIC), which is now virtual due to COVID-19 and will be held on July 27th-July
31st. The researchers involved in the study will create a presentation video/poster board with the

prevalent data will be shown at both conferences.

References

Abete, P., Della-Morte, D., Gargiulo, G., Basile, C., Langellotto, A., Galizia, G., … Cacciatore,
F. (2014). Cognitive impairment and cardiovascular diseases in the elderly. A heart–brain
continuum hypothesis. Ageing Research Reviews, 18, 41–52.
https://doi.org/10.1016/j.arr.2014.07.003

Centers for Disease Control and Prevention. (2019, April 5). What Is Dementia? Centers for
Disease Control and Prevention. https://www.cdc.gov/aging/dementia/index.html.

Centers for Disease Control and Prevention. (2020, June 22). Heart Disease Facts. Centers for
Disease Control and Prevention. https://www.cdc.gov/heartdisease/facts.htm.

Heart Disease Linked to Dementia in Women. www.goredforwomen.org.

https://www.goredforwomen.org/en/about-heart-disease-in-women/facts/heart-disease-
linked-to-dementia-in-women.

Karlsson, I. K., Ploner, A., Song, C., Gatz, M., Pedersen, N. L., & Hägg, S. (2017). Genetic
susceptibility to cardiovascular disease and risk of dementia. Translational
Psychiatry, 7(5). https://doi.org/10.1038/tp.2017.110
Kumar, V. V., Huang, H., Zhao, L., Verble, D. D., Nutaitis, A., Tharwani, S. D., … Wharton, W.
(2020). Baseline Results: The Association Between Cardiovascular Risk and Preclinical
Alzheimer’s Disease Pathology (ASCEND) Study. Journal of Alzheimer's Disease, 75(1),
109–117. https://doi.org/10.3233/jad-191103

Muqtadar, H., Testai, F. D., & Gorelick, P. B. (2012). The Dementia of Cardiac
Disease. Current Cardiology Reports, 14(6), 732–740. https://doi.org/10.1007/s11886-012-
0304-8

Newman, A. B., Fitzpatrick, A. L., Lopez, O., Jackson, S., Lyketsos, C., Jagust, W., … Kuller, L.
H. (2005). Dementia and Alzheimer's Disease Incidence in Relationship to Cardiovascular
Disease in the Cardiovascular Health Study Cohort. Journal of the American Geriatrics
Society, 53(7), 1101–1107. https://doi.org/10.1111/j.1532-5415.2005.53360.x

Office of Minority Health. Home Page - Office of Minority Health (OMH).

https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=4.

Tini, G., Scagliola, R., Monacelli, F., Malfa, G. L., Porto, I., Brunelli, C., & Rosa, G. M. (2020).
Alzheimer’s Disease and Cardiovascular Disease: A Particular Association. Cardiology
Research and Practice, 2020, 1–10. https://doi.org/10.1155/2020/2617970

What Is Dementia? Alzheimer's Disease and Dementia. https://www.alz.org/alzheimers-

dementia/what-is-dementia.

Appendix A: Pilot Study Survey

https://unf.co1.qualtrics.com/jfe/form/SV_1AqEeSD0hfbD1cx

Appendix B: Code Book

Vari
able Question Q Q Q
Nam from Answers to the Variabl Reco Q Q Q Q8_7_ Q 1 1 1 Q
# e Survey Categories e Type de 6 7 8 TEXT 9 0 1 2 13
1 Start I am 65+ How old are Text None                  
Date years of were when you
age, I were
have diagnosed with
been a
diagnose cardiovascular
d with a disease?
cardiova
scular
disease,
 and I live
in Duval
County.
How old
are were
when 65
you 66
were 67
diagnose 68
d with a 71
cardiova 75
scular 78 Categor
2 Q3 disease? 80 ial None                  
65-70 years old
How old 71-79 years old Categor
3 Q4 are you? 80+ years old ial None                  
Male
What is =1,
your Female Numeri Fema
4 Q5 sex? Male c le=2                  
Are you
Spanish, None
Hispanic, of
or Latino these
or none =1
of None of these Numeri Yes=
5 Q6 these? Yes c 1                  
American
Indian or
Alaska Native
Asian
Choose Black or
one or African
more American
races Native
that you Hawaiian or
consider Pacific Islander
yourself Other Categor
6 Q7 to be: White ial None                  
7 Q8 Which Not working Categor None                  
stateme (disabled) ial
nt best Not working
describe (looking for
s your work)
employ Not working
ment (other)
status Not working
 while
being
diagnose
d? - (retired)
Selected Working (paid
Choice employee)
What
type of
cardiova
scular
disease
were
you
diagnose
d with?
(Cardiov
ascular
disease
is a class
of
disease
that Coronary
involve Artery Disease
the Hypertension
heart or Myocardial
blood Infarction (i.e. Categor
8 Q9 vessels). heart attack) ial None                  
9 Q10 Family No; no one in Categor None                  
History my family has ial
of cardiovascular
Cardiova diseaseYes;
scular fatherYes;
Disease father,Yes;
Check all paternal
that grandmotherY
Apply: es; father,Yes;
paternal
grandmother,Y
es; paternal
grandfatherYes
; maternal
grandfatherYes
; maternal
grandmotherY
es;
mother,Yes;
fatherYes;
mother,Yes;
 father,Yes;
maternal
grandfather,Ye
s; maternal
grandmother,Y
es; paternal
grandmother,Y
es; paternal
grandfather
No; no one in
my family has
Dementia
Yes; father
Yes; maternal
grandmother
Yes; Mother
Yes;
Mother,Other
(not
immediate
family member
Yes;
Mother,Yes;
father,Yes;
maternal
grandfather,Ye
s; maternal
grandmother,Y
es; paternal
grandmother,Y
es; paternal
grandfather
Family Yes; paternal
History grandfather,Ot
of her (not
Dementi immediate
a Check family member
1 all that Yes; paternal Categor
0 Q11 Apply: grandmother ial None                  
1 Q12 Since No Numeri No=1                  
1 being Yes c Yes=
diagnose 1
d have
you
been
experien
cing any
memory
 changes
?
Forgetting the
day
Forgetting
what I just said
Forgetting who
If you my children
answere are
d yes to Forgetting who
previous my family is
question I forget that
, please I’m a woman
describe Leaving the
what has stove on
changed. My memory is
(Ex: not as sharp
forgettin Repeating
1 g car myself multiple Categor
2 Q13 keys) times ial None                  
                             
Appendix C: Human Subjects

Human Subjects

Basic Information about the study

The research study is entitled “Dementia in Cardiovascular disease”. The purpose of this

research will be to assess how cardiovascular disease (i.e. MI, HTN, and CAD) can create a

cognitive impairment. Two of the most common diseases in the elderly seem to be

Cardiovascular disease and dementia. With this in mind, it has been hypothesized that heart

disease and dementia may be linked together through common risk and other pathogenic

elements. The aim of this study is to answer the question, “Does having pre-existing

Cardiovascular disease affect the development of Dementia”? All the data will acquired through

a convenience sampling method. Their information will not be used if that they are not willing to

take impart of the study. This study will be utilizing univariate analysis, bivariate analysis, and

multivariate analysis. Patient identifiers will not be used in this study. Although the researchers

will be obtaining medical records from each participants, none of the information used from the

medical records will be linked to the patient’s name directly. The computers which contain the

patient’s data will be encrypted.

The Study Population Characteristics

This study will be limited to about 3,000 who are 65 and older. Candidates for this study

can be either men or women and there are no restrictions on race or ethnicity. This study will

take into account many demographic characteristics. The researchers will collect information

from both males and females. They will answer what they consider their race to be (i.e. African

American, Caucasian, Asian, etc.), whether they are Hispanic/Latino or not, and when being
diagnosed with CVD what their employment status was. It is important that they subjects are of

65 years old and older due to previous research that around this age is where heart disease

becomes more prevalent and dementia tends to be seen in older populations. It is very rare to see

a development of dementia or having cardiovascular disease in a younger population. If a

candidate chooses to participate in this study they will receive a $75 gift card as an incentive. By

providing this incentive, it will increase the volunteer numbers in each category so the data can

be as even as possible. After the final follow up has been completed that is when the participants

will receive their gift card.

The Protection of subjects

The participants in the study have to be diagnosed with cardiovascular disease; whether it

be Coronary Artery Disease, High Blood Pressure, or having had a heart attack. During each

follow up (initial, 6 months, one year, and two year) each participant will need to endure certain

imaging to compare to the other prior tests being done. With the multiple imaging, the

participant has a greater exposure to radiation, although minor and not all at once it can still be

dangerous. This researchers take the participant’s privacy very seriously. The only person who

will be responsible for obtaining all the participant data will be the data collector and be saved in

their computer in the specific system.

Ethnic Categories
Not Hispanic or Latino Hispanic or Latino Total
Racial
Male Female Male Female
Categories
American
Indian/Alaskan 125 125 125 125 500
Native
Asian 113 113 112 112 450
Native
Hawaiian or 125 125 125 125 500
other Pacific
Islander
African 138 138 137 137 550
American/Black
White 125 125 125 125 500
More than one 125 125 125 125 500
race
Total 751 751 749 749 3,000
Appendix D: Consent

INFORMED CONSENT FORM

to Participate in Research, and

AUTHORIZATION
to Collect, Use, and Disclose Protected Health Information (PHI)

Title of this study: Dementia in Cardiovascular disease

Researchers: Yusneisy Cuellar

You are being asked to participate in a research study.

Before you agree to take part in this study, Yusneisy Cuellar

or his/her representative will tell you:

 Why the study is being done and what will happen to you if you take part in the study:
The aim of this study is to show people the effects of having cardiovascular disease and
how it can have an impact on older adults developing Dementia. During this study the
researchers will use your medical records to receive a better understanding of your
cardiovascular history. As a participant you will be divided into three groups. One group
will be participants who were affected by a heart attack (MI) in the last five years. The
second group will be participants who have been suffering from high blood pressure in the
last five years. Finally the third group will be the participants that have never been
diagnosed with cardiovascular disease. Being a part of this study your will be examined by
a Cardiologist and a Neurologist. You will undergo Electrocardiogram, Magnetic
Resonance Imaging, or Computed Tomography.

 How long you will be in the study:

The study will begin once we receive your detail medical records explaining your
cardiovascular history. The questionnaire will be provided to you that will give the
researchers a better understanding about demographic characteristics that deal with
the development of Dementia (i.e. family history). After initial data has been collected
the researchers will conduct follow up appointments to test how developed your
cardiovascular disease has gotten and if you developed any cognitive impairment prior
to the follow up appointment. The follow up appointment go as follows; 6 months, one
year, and two years. Ideally the end of the study will be after the 2 year follow up.

 How many people will be in the study:

 This study will be utilizing about 3000 participants. The first group should be ideally
1,000 of either males or females who have experienced a heart attack in the last five
years. The second group of 1,000 would be the group of males and females who were
diagnosed with high blood pressure in the last five years. Finally the last group of 1,000
would be the group of males and females who have never been diagnosed with
cardiovascular disease.

 The possible foreseeable risks, discomforts, and benefits of this research:

The possible foreseeable risk that could be seen in this study is for the group that has never
been diagnosed with cardiovascular disease could develop CVD over time or dementia.
Depending their family history there is a possibility of the participants developing the
disease even without having any risk factors to begin with. The discomforts would be being
exposed to radiation, although the imaging will only be done at the initial start of the study,
then at 6 months, than a year, and finally at the 2 year mark it can become concerning to
some people who do not want to be exposed to the added radiation.

 Alternatives to being in the study:

This study is completely voluntary. Anyone who does not wish to participate in the study or
continue in the study do not have to.

 How your study records will be maintained and who will have access:
The data coordinator will be in charge of collecting all the date for this study. The data being
collected for this study will include the medical records of each participant, prior imaging
and EKG to compare to the newly collected imaging. Data will be available for all the
research team personal to access throughout the study. However the data collector will be
the only one able to format the data in the system in their private computer. The data will
be filed for each specific type of data and medical records. The date will be filed again into a
separate file for each participant to ensure there is no confusion or misplace of data.

 If it will cost you anything to take part in this study:

For this study there will be no cost to participate. All diagnoses, imaging, and prevention
cost will need to be handled by the participants and their health insurance.
.

 When or if you may be told about new findings which may affect your willingness to
keep taking part in this study:
The study was created with the aim of understanding the correlation between
Cardiovascular disease and the development of Dementia. The findings from this study will
ensure that other health concerns can affect brain function. Hopefully after the study has
been completed it would give an understanding to the community on developing healthy
habits to protect oneself from developing cardiovascular disease.

If you agree to participate in this study, you will be given a signed copy of this
document.
You may contact at Yusneisy Cuellar (888) 888-8888 at any time if you have questions
about the research or if you think that you have been hurt by the research.

You may contact the Institutional Review Board at the University of Mid-Florida Health
Science Center at (999) 999-9999 if you have questions about your rights as a research
subject or what to do if you are injured.

You may choose not to be in this study or you may quit being in the study at any time
and there will be no penalty and no loss of any benefits you are entitled to.
If you agree to participate in this study, Yusneisy Cuellar will create, collect, and use
private information about you and your health. This information is called protected health
information or PHI. In order to do this, the Principal Investigator needs your authorization.

More specifically, the following information may be collected, used, and shared with
others:

 Data from the questionnaire survey

 Medical Records; including family hx of the participant
 Older diagnosed test results to compare to the new imaging results
 Imaging test results
This information will be stored in locked filing cabinets or in secure computer servers with
security passwords.
Your PHI may be collected, used, and shared with others for the following study-related
purpose(s):
 To determine the correlation between cardiovascular disease and the development
of dementia.
Once this information is collected, it becomes part of the research record for this study.
Only certain people have the legal right to collect, use and share your research records,
and they will protect the privacy and security of these records to the extent the law allows.
These people include:

 the study Principal Investigator, and research staff associated with this project.
 other professionals at the University that provide study-related treatment or
procedures
 University of Mid-Florida Institutional Review Board (IRB; an IRB is a group of
people who are responsible for looking after the rights and welfare of people
taking part in research).
Your PHI may be shared with:

 Sponsor
 United States and foreign governmental agencies who are responsible for
overseeing research, such as the Food and Drug Administration, the Department
of Health and Human Services, and the Office of Human Research Protections

 Government agencies who are responsible for overseeing public health concerns
such as the Centers for Disease Control and federal, state and local health
departments

Otherwise, your research records will not be released without your permission unless
required by law or a court order. It is possible that once this information is shared with
authorized persons, it could be shared by the persons or agencies who receive it and it
would no longer be protected by the federal medical privacy law.

Your PHI will be used and shared with others until the end of the study (or alternative).

Once this research study is completed, any information that could identify you might be
removed from any identifiable private information or identifiable biospecimens collected
and that, after such removal, the information or biospecimens could be used for future
research studies or distributed to another investigator for future research studies without
additional informed consent from you or your legally authorized representative.

You are not required to sign this consent and authorization to allow researchers to collect,
use and share your PHI. Your refusal to sign will not affect your treatment, payment,
enrollment, or eligibility for any benefits outside this research study. However, you cannot
participate in this research unless you sign this consent and authorization.
You have the right to review and copy your protected health information. However, we
can make this available only after the study is finished.
You can revoke your authorization at any time before, during, or after your participation in
this study. If you revoke it, no new information will be collected about you, but information
that was already collected may still be used and shared with others if the researchers
have relied on it to complete the research. You can revoke your authorization by giving a
written request with your signature on it to the Principal Investigator.

Signing this document means that the research study, including the above information,
has been described to you orally and/or that you have read this document, and you
voluntarily agree to take part.
________________________________ ______________
Signature of Person Obtaining Consent Date

________________________________ ______________
Consent and Authorization of Patient Date
Appendix E: Budget and Timeline

Budget

Personnel Salary Benefits % time Total

Data Analyzer $25,000 $7,500 100% $25,750
(1)
Researcher $10,000 $3,000 100% $1,300
Assistant (1)
Neurologist (1) $60,000 $18,000 0.55% $60,990
Cardiologist (1) $60,000 $18,000 0.55% $60,990
Other Expenses X $60,000 0.14% $840
Equipment and X X X X
Supplies
EKG Machine (1) $2,850 X 19.18% $546.63
MRI Machine (1) $65,000 X 19.18% $12,467
Communications $600 X 25.07% $150.42
Travel $1,000 X 0.55% $55
Total Direct $69,450 X 100% $6,945
Costs
Total Indirect $155,000 X 100% $11,500
Costs
Total Requested $224,450 $106,500 X $181,534.05

Tmeline
Activity Sep Oc No De Ja Fe Marc Apri Ma Jun Jul Aug
t t v c n b h l y e y
Create the X
questionnaire being
sent out to the
participants
Read the relevant X X
literature
Finalize Study Goals X
 Start interviewing and X X
do first initial exams on
the participants
Draft Protocol X X X X
Submit institutional X X X
review application
Draft Methods section X X
Analyse the data X X
Submit Abstract to X
Conference
Revise Introduction and X X
discussion sections of
the paper
Revise Manuscript X
Present at Conference X
Submit Manuscript X