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 Part I

Information to participants / legally acceptable representatives of participants in case they

are minor or likely to be mentally incompetent.

 Title of the study

“An Objective Evaluation of Coronary Artery Disease using Spatial Vectorcardiography and
Digital Phonocardiography.”

 What is the purpose of this study?

Coronary artery disease is one of the major and serious diseases in the world today. As complex as
the consequences are, the cost of treating this disease is also extremely high. There are ample scope to
elucidate the detail pathophysiological explanation of the disease and its emerging pattern, which
may open new horizons in the treatment of this heart disease.

The present research project has initiated to explore towards a detailed physiological explanation of
coronary artery disease by three-dimensional vectorcardiography and digital phonocardiography
examination. This will not only increase our knowledge of heart disease, but also propose a newer
ways of management of CAD as an easily available and low-cost tool.

 Why have I been chosen?

You are being chosen because; you’re perfectly suitable for participation in the research project as per
selection criteria.

 Do I necessarily have to take part?

That is entirely your discretion whether to participate in the study or not. However, we appeal to you
to take part in the study for the best interest of the science and the society.

 What happens during the study / what do I have to do? (the procedures, such as answering a
questionnaire, which the participant will have to undergo)
1. To answer some questions, regarding your health, disease and treatment.
2. To provide the necessary medical records pertaining to your disease and treatment.
3. To allow us to record a digital electrocardiogram (ECG) of yourself.
4. To allow us to record a digital phonocardiogram (Heart sounds) of yourself.
5. To allow us to record other related physiological parameters of yourself.

 What are the possible benefits of taking part?

a) Your voluntary participation in this research study will make it successful and help to
understand the Coronary Artery Disease in detail and better, and thus facilitate to formulate a
more effective diagnostic and management protocol which will be easily available and low-
cost.
b) Your health will be thoroughly checked
c) You would perform a noble duty towards society.
  Are there any possible disadvantages of taking part?
There is no disadvantage to participate in this study. Only thing is, you have to provide some
time for this endeavor.

 Will my taking part in this study be kept confidential?

All the information regarding your identity, medical information etc will ne kept strictly
confidential.

 What will happen to the results of the study?

The results of the study will be utilized to develop an appropriate non-invasive diagnostic, prognostic
and research tool for Coronary Artery Disease.

 Any other information relevant to participation in the study.

The study will be conducted for three years; so your follow-up information and data will be
necessary for which the investigators may contact you in future occasion also.
 Contact for further information. (the name designation and contact numbers of Principal
Investigator and Co-Investigators)

1. Prof. Arnab Sengupta, PI

Dept. of Physiology, IPGME&R.
Tel: +919433173294.

2. Prof. Dipankar Mukhopadhyay, Co-PI

Dept. of Cardiology, IPGME&R.
Tel: +919433020897.

 A statement thanking the participant for going through the informed consent document.
We wholeheartedly extend our thanks and gratitude to go through this Informed Consent
document. We hope we shall get your cooperation for this research project.
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