The AIIMS Cohort Study is envisaged to look at otherwise healthy population in the urban and rural community and follow them up over a period of time, to look at the factors which may cause stroke, memory problems and/or heart attack. Some people with these factors may never develop any such event and some people without any known factors may get an event. Therefore, it is important to find out the unknown factors which may be associated with these events. By participation in the study, the society at large will benefit from the results of the study, even though there may only little tangible benefit to an individual. As a participant of the study, you will undergo a number of tests. If any test picks up any finding which deserves medical attention, it will be intimated to you. In this way it might help you in early diagnosis and treatment.

AIIMS doctors from twelve Departments including Neurosciences Centre & Department of Community Medicine.

• Get your detailed Health Check-up done by AIIMS doctors free of cost.
• To contribute to building knowledge for prevention of stroke, heart attack and dementia.
• Play an active part in your own healthcare, which will not only help you but also pave way for helping society at large.

• Step I – Meet Research Staff who will visit your home and explain about the study. Further, with your consent for the study, next visit will be scheduled.
• Step II – Complete a more detailed survey at your home.
• Step III – Health check-up at hospital.
• Step IV – MRI of brain.

Residents of Vasant Kunj aged 50 years and above.

All eligible persons will be asked to visit the hospital where their physical examination (including weight, height blood pressure measurement, dental examination etc.), blood test, MRI Brain, ECG, ECHO and Carotid Doppler will also be carried out. All investigations will be done free of cost.

• At hospital site: Health Checkup- Approx. 4 hours (including waiting time)
  MRI – 2 hours (including waiting time)
• Follow up: 6 monthly over telephone.
• Repeat Health Checkup: After 3 years.

There are several tests which are done, including blood tests. We plan to give you basic blood and biochemistry tests for your record (sample copy enclosed). However, there are several tests which are being done solely for research purpose and we do not know for sure if they have any clinical value in asymptomatic healthy individuals. Also the echocardiography and MRI brain are being done under research protocol and not the usual clinical protocol. If any finding which deserves further clinical evaluation is detected, it will be intimated to you. Only a summary impression of MRI brain, echo etc. will be provided in routine cases

We are conducting a detailed neuropsychometry tests in all healthy consenting participants. During the evaluation, if we detect any finding which requires further evaluation and treatment, you will be advised to consult the concerned doctor. However, there is no provision of giving report to the participants since it is collection of data from normal people

If any test, for example, blood pressure, blood sugar, Echocardiography, MRI brain etc. is abnormal, it will be intimated to you to take a clinical consult by your physician for the same. If you require this consult from AIIMS, we will help you in getting the initial appointment. You are however; free to take an opinion outside AIIMS. Provision of detailed report/films in such cases will not be provided since they may not be applicable for clinical use. This is applicable for consults both within and outside AIIMS

When you will come to the medical site, you will be provided snacks. Participants who come fasting in the morning shift will be provided breakfast. We will be doing the MRI after 8.00 PM and would advise you to have your dinner before you come for MRI test. You are free to bring your snacks when you come for the MRI. You are also free to bring your snacks to the medical site if you so prefer

Yes, if a wheelchair is required, you will be provided with a wheelchair and attendant

As mentioned earlier, the MRI is being done under research protocol and therefore no film/CD will be provided. The same procedure is being followed in other similar studies worldwide

As explained earlier, you will only be provided summary information in one line

As a participant of the study, you will be facilitated for medical requirements on OPD/IPD/emergency basis, especially in the departments which are a collaborator in the AIIMS cohort study

Risks

• Risks associated with having the blood drawn are slight but may include: bleeding, fainting or feeling light headed.
• You will undergo clinical investigations like MRI of brain, ECG, heart and neck ultrasound which are painless.

No injury is likely to be caused by the study as no new treatment is being used but if there are any study related injury or side effects, treatment will be provided without any cost to you.

The cost of services, laboratory tests and transportation (to & fro from the hospital) which are considered to be part of the study will be covered. [Supported by Government of India, Department of Biotechnology]

Your identity will be kept anonymous and confidential, only authorized research staff will have access to all the information.

No

No

• You may withdraw your consent at any point of time; without any obligation or charge.
• Inform research staff about your decision.

Spread this information among your friends and community, and encourage them to participate in the study.