| CTRI Number |
CTRI/2019/06/019948 [Registered on: 28/06/2019] Trial Registered Prospectively |
| Last Modified On: |
24/07/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy
Preventive
Behavioral
Other (Specify) [Cardiac Rehabilitation] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of cardiac rehabilitation in patients undergone myocardial infarction and percutaneous coronary intervention |
|
Scientific Title of Study
|
A Randomized Controlled Trial of Cardiac Rehabilitation in
Myocardial Infarction Patients with Percutaneous Coronary Intervention |
| Trial Acronym |
MY-CARE |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kunjan |
| Designation |
PhD Student |
| Affiliation |
PGIMER |
| Address |
Department of Community Medicine and School of Public Health, PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9459856115 |
| Fax |
|
| Email |
dr.kunjan2human@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr JS Thakur |
| Designation |
Professor |
| Affiliation |
PGIMER |
| Address |
Department of Community Medicine and School of Public Health, PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9463602173 |
| Fax |
|
| Email |
jsthakur64@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr JS Thakur |
| Designation |
Professor |
| Affiliation |
PGIMER |
| Address |
Department of Community Medicine and School of Public Health, PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9463602173 |
| Fax |
|
| Email |
jsthakur64@gmail.com |
|
|
Source of Monetary or Material Support
|
| Fellowship from Postgraduate Institute of Medical Education and Research, Chandigarh |
|
|
Primary Sponsor
|
| Name |
Dr JS Thakur |
| Address |
Department of Community Medicine and School of Public Health, PGIMER |
| Type of Sponsor |
Other [Professor of Community Medicine] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kunjan |
PGIMER |
Advanced Cardiac Centre (Department of Cardiology) OPD, Department of Community Medicine and School of Public Health
Chandigarh
CHANDIGARH |
9459856115
dr.kunjan2human@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institute Ethic Committee (Intramural) |
Approved |
| Institute Ethics Committee(Intramural) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cardiac rehabilitation |
Adapted phase II and phase III of cardiac rehabilitation program with components of physical activity, education on coronary artery disease and heart-healthy living
|
| Comparator Agent |
Routine care |
Participants will not receive any supervised physical activity training. Participants will receive routine care for myocardial infarction after undergoing percutaneous coronary intervention according to current guidelines.
|
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. 18-80 years of age
2. Patients diagnosed with myocardial infarction who have undergone percutaneous coronary intervention and are not at risk due to other comorbidities.
3. Willing to give informed consent
4. Patients with New York Heart Association, NYHA functional class I, II & III symptoms
|
|
| ExclusionCriteria |
| Details |
1. Participants with medical conditions which could put them at risk during physical activity testing or training e.g., angina or conditions that could limit the ability of participants to exercise e.g., severe orthopaedic or neurologic impairments |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
Modification(s)
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Physical activity
Functional capacity
Knowledge related to coronary artery disease
Depression scores
Medication adherence |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Health related quality of life.
Anthropometric measures: Body Mass Index (BMI), Waist circumference.
Risk profile and biochemical measures: BP(Blood Pressure), LDL(Low Density Lipoprotein), HDL(High Density Lipoprotein), Fasting glucose, HbA1c
Cost effective implementation of cardiac rehabilitation model
All-cause mortality |
6 months |
|
|
Target Sample Size
|
Total Sample Size="382"
Sample Size from India="382"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="382" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
02/07/2019 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This study is a two-group randomized controlled trial with participants who have experienced myocardial infarction and who have already undergone percutaneous coronary intervention as well. At the end of a period of 6 months, the primary outcomes will be measured with respect to physical activity, functional capacity, knowledge related to coronary artery disease, depression scores, medication adherence. Secondary outcome measures will be health related quality of life; anthropometric measures i.e., body mass index, waist circumference; risk profile; biochemical measures i.e., blood pressure, low density lipoprotein, high density lipoprotein, fasting glucose, HbA1c; cost effective implementation of cardiac rehabilitation model and all-cause mortality. |