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CTRI Number  CTRI/2022/05/042672 [Registered on: 19/05/2022] Trial Registered Prospectively
Last Modified On: 20/12/2022
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   Participation in Rehabilitation post cardiac event like heart attack or angioplasty or bypass surgery to know the change in lifestyle behaviour and ability to carry out work 
Scientific Title of Study   Participation In International cardiac Rehabilitation Registry  
Trial Acronym  ICRR 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mariya Jiandani 
Designation  Assoc Professor 
Affiliation  Seth G S Medical College & KEMH 
Address  Physiotherapy School and centre Seth G S Medical College and KEMH Cardiovascular and thoracic centre cardiac rehabilitation OPD room no 16 Parel Mumbai 12
Physiotherapy School and centre Seth G S Medical College and KEMH Cardiovascular and thoracic centre cardiac rehabilitation OPD room no 16 Parel Mumbai 400012
Mumbai
MAHARASHTRA
400012
India 
Phone  9820101196  
Fax    
Email  mpjiandani@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Mariya Jiandani 
Designation  Assoc Professor 
Affiliation  Seth G S Medical College & KEMH 
Address  Physiotherapy School and centre Seth G S Medical College and KEMH Cardiovascular and thoracic centre cardiac rehabilitation OPD room no 16 Parel Mumbai 12
Physiotherapy School and centre Seth G S Medical College and KEMH Cardiovascular and thoracic centre cardiac rehabilitation OPD room no 16 Parel Mumbai 400012
Mumbai
MAHARASHTRA
400012
India 
Phone  9820101196  
Fax    
Email  mpjiandani@gmail.com  
 
Details of Contact Person
Public Query  
Name  Mariya Jiandani 
Designation  Assoc Professor 
Affiliation  Seth G S Medical College & KEMH 
Address  Physiotherapy School and centre Seth G S Medical College and KEMH Cardiovascular and thoracic centre cardiac rehabilitation OPD room no 16 Parel Mumbai 12
Physiotherapy School and centre Seth G S Medical College and KEMH Cardiovascular and thoracic centre cardiac rehabilitation OPD room no 16 Parel Mumbai 400012
Mumbai
MAHARASHTRA
400012
India 
Phone  9820101196  
Fax    
Email  mpjiandani@gmail.com  
 
Source of Monetary or Material Support  
international cardiac rehabilitation registry will be providing digital support. There is no monetary funding or support  
 
Primary Sponsor  
Name  International Cardiac Rehabilitation Registry 
Address  Professor Sherry L. Grace, PhD, FCCS, FAACVPR, CRFC Professor, Faculty of Health York University – Bethune 368 4700 Keele Street; Toronto, ON M3J 1P3 sgrace@yorku.ca  
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India
Qatar
Canada
Iran (Islamic Republic of)  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Mariya Jiandani  Physiotherapy School & Centre Seth GS Medical College  Physiotherapy School and centre Seth G S Medical College and KEMH Cardiovascular and thoracic centre cardiac rehabilitation OPD room no 16 Mumbai 12
Mumbai
MAHARASHTRA 		 9820101196

mpjiandani@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Seth GS MEdical Institutional Ethics committe  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I21||Acute myocardial infarction, (2) ICD-10 Condition: I20||Angina pectoris, (3) ICD-10 Condition: I23||Certain current complications following ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction (within the 28 day period), (4) ICD-10 Condition: I25||Chronic ischemic heart disease, (5) ICD-10 Condition: I255||Ischemic cardiomyopathy, (6) ICD-10 Condition: I237||Postinfarction angina, (7) ICD-10 Condition: I22||Subsequent ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Heart disease patients from age group of 20-80 yrs of either gender who are indicated for phase 2 Cardiac rehabilitation and referred for same by cardiologist are eligible for registry inclusion such as :
• coronary syndrome with or without revascularization,
• Patients with heart failure,
• Patients with stable coronary artery disease , valve or rhythm conditions
• Patients with stable cardiac problems secondary to covid
 
 
ExclusionCriteria 
Details  Patients with known cognitive or mental impairment.
• Patients refusing to participate in cardiac rehabilitation program
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
• Positive Impact of Cardiac Rehabilitation program on cardiac Risk factors and heart healthy behavior in the Indian scenario,
• Education and awareness of Cardiac Rehabilitation and Preventive heart care
 		 2yrs 
 
Secondary Outcome  
Outcome  TimePoints 
• Quality Check of Cardiac Rehabilitation program in comparison to Global standards  2 yrs 
 
Target Sample Size   Total Sample Size="1000"
Sample Size from India="500" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   13/10/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  30/06/2022 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   This is a prospective longitudinal observational registry. The aim is to participate in the international cardiac rehab registry to establish the quality of cardiac rehabilitation services as compared globally and assess the effectiveness of phase 2 cardiac rehabilitation in improving lifestyle associated behaviour, change in physical activity levels and peak METS post participation in cardiac rehabilitation. complete ennumeration methods for a period of two years for all patients being referred for cardiac rehabilitation would be applied. 
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