| CTRI Number |
CTRI/2013/03/003511 [Registered on: 25/03/2013] Trial Registered Prospectively |
| Last Modified On: |
18/11/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative Health effectiveness between Optimal Medical Therapy and routine invasive strategy treatment |
|
Scientific Title of Study
|
International Study of Comparative Health Effectiveness with Medical and Invasive Approaches |
| Trial Acronym |
ISCHEMIA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 1U01HL105907 |
Protocol Number |
| NCT01471522 |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Balram Bhargava |
| Designation |
Non Invasive Cardiologist |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
1st Floor, Old OT Block,
Opp. Directors Bunglow
All India Institute of Medical Sciences
New Delhi
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
balrambhargava@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Balram Bhargava |
| Designation |
Non Invasive Cardiologist |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
1st Floor, Old OT Block,
Opp. Directors Bunglow
All India Institute of Medical Sciences
New Delhi
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
balrambhargava@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Balram Bhargava |
| Designation |
Non Invasive Cardiologist |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
1st Floor, Old OT Block,
Opp. Directors Bunglow
All India Institute of Medical Sciences
New Delhi
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
balrambhargava@yahoo.com |
|
|
Source of Monetary or Material Support
|
| National Heart, Lung, and Blood Institute (NHLBI) |
|
|
Primary Sponsor
|
| Name |
New York University School of Medicine |
| Address |
Cardiovascular Clinical Research Center
New York University School of Medicine
530 First Avenue, Skirball 9R
|
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Argentina
Australia
Austria
Belgium
Brazil
Canada
Chile
China
France
Germany
Hungary
India
Israel
Italy
Japan
Mexico
New Zealand
Peru
Poland
Portugal
Republic of Korea
Russian Federation
Serbia
Singapore
Spain
Sweden
Thailand
United Kingdom
United States of America |
Sites of Study
Modification(s)
|
| No of Sites = 20 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Balram Bhargava |
All India Institute of Medical Sciences |
Department of cardiology
1st Floor, Old OT Block,
Opp. Directors Bunglow
All India Institute of Medical Sciences
New Delhi
DELHI |
011-26593758
balrambhargava@yahoo.com |
| Dr Sudhir Naik |
APOLLO Health City Campus |
APOLLO HEALTH CITy, JUBILEE HILLS, HYDERABAD:500096,
Hyderabad
ANDHRA PRADESH |
9849036090
sudhir.r.naik@gmail.com |
| Dr Robert Mao |
APOLLO Hospitals |
APOLLO HOSPITALS ENTERPRISE LIMITED, 21, Greams Lane, Off Greams Road, CHENNAI: 600006
Chennai
TAMIL NADU |
9841700824
robertmao92@yahoo.com |
| Dr Johann Christopher |
CARE Hospital |
CARE Hospital, Banjara Hills, Hyderabad , Telangana- 500034
Hyderabad
ANDHRA PRADESH |
9701445011
Johann1403@gmail.com |
| Dr Johann Christopher |
CARE Nampally |
CARE Nampally, Hyderabad, Telangana- 500001
Hyderabad
ANDHRA PRADESH |
9701445011
Johann1403@gmail.com |
| Dr Gurpreet Singh Wander |
Dayanand Medical College |
Unit-Hero DMC Heart Institute
Ludhiana-141001
Ludhiana
PUNJAB |
9815545316
drgswander@yahoo.com |
| Dr Neeraj Pandit |
Dr. Ram Manohar Lohia Hospital |
Department of cardiology
Baba Kharak Singh Marg, Connaught Place, New Delhi
New Delhi
DELHI |
9810469475
drneerajpandit@gmail.com |
| Dr Upendra Kaul |
FORTIS ESCORTS HEART INSTITUTE |
FORTIS ESCORTS HEART INSTITUTE, Okhla Road New Delhi 110025
New Delhi
DELHI |
9811150518
upendra.kaul@fortishealthcare.com |
| Dr Upendra Kaul |
Fortis Healthcare Flt Lt Rajan Dhall Hospital |
Fortis Flt Lt Rajan Dhall Hospital, Sector B, Pocket 1, Aruna Asaf Ali Marg,Vasant Kunj, New Delhi, Delhi 110070, India
New Delhi
DELHI |
09811150518
upendra.kaul@fortishealthcare.com |
| Dr CGSajeev |
Government Medical College |
Government Medical College, Medical College Road, Kozhikode-673008
Kozhikode
KERALA |
9846035722
sajeev.cg@gmail.com |
| Dr Johann Christopher |
Gurunanak CARE Hospital |
Gurunanak Care Hospital, D.No. 1-4-908/7/1, Musheerabad Hyderabad- 500034
Hyderabad
ANDHRA PRADESH |
9701445011
Johann1403@gmail.com |
| DrMilind Gadkari |
KEM Hospital and Research Center |
King Edward Memorial (KEM) Hospital, KEM Hospital Research Center, 3rd floor, TDH Building Room No.313, Rasta Peth, Sardar Moodliar Road, Pune-411011, Maharashtra
Pune
MAHARASHTRA |
9822030120
gadkaris@gmail.com |
| Dr SK Dwivedee |
King George Medical University |
King George Medical University Shah Mina Road, Chowk, Lucknow, Uttar Pradesh 226003
Lucknow
UTTAR PRADESH |
9935037620
dr_skdwivedi@rediffmail.com |
| Dr Anoop Mathew |
MOSC Medical College Hospital |
MOSC Medical College Hospital, Kolenchery-682311.
Ernakulam
KERALA |
08281502606
anoopmatts@gmail.com |
| Dr Purvez Grant |
Ruby Hall Clinic |
Soraj Building 4th Floor,Ruby Hall Clinic Pvt Ltd Services, Next to the Quality Regency Hotel, Dhole Patil Road Pune -411001
Pune
MAHARASHTRA |
09822013999
purvez_grant@hotmail.com |
| Dr Chander Bhan Meena |
Savaii Maan Singh Medical College |
Department of Cariology, SMS Hospital
Near Ram Niwas Bagh, Jawaharlal Nehru Marg, Jaipur
Jaipur
RAJASTHAN |
9414250934
drcbhan@gmail.com |
| Dr Rajneesh Jain |
Sir Ganga Ram Hospital |
Sir Ganga Ram Hospital, Sir Ganga Ram Hospital Marg, Rajinder Nagar, New Delhi-60, India.
New Delhi
DELHI |
9810264606
jainsaniya@yahoo.com |
| Dr Jagan Mohan Tharakan |
Sree Chitra Tirunal Institute for Medical Sciences & Technology |
Sree Chitra Tirunal Institute for Medical Sciences & Technology, (SCTIMST) Trivandrum, Thiruvananthapuram - 695 011, Kerala, India
Thiruvananthapuram
KERALA |
0471-2524500
jaganmohan.tharakan@hotmail.com |
| Dr CN Manjunath |
Sri Jayadeva Institute of Cardiovascular Sciences and Research |
Bannerghatta Road 9th Block Jayanagar, Bangalore- 560069
Bangalore
KARNATAKA |
9844006699
ravismath@rediffmail.com |
| DrSantosh Satheesh |
The Jawaharlal Institute of Postgraduate Medical Education & Research (JIPMER) |
Department of Cardiology,
Dhanvantri Nagar, Gorimedu, Puducherry, Puducherry
Pondicherry
PONDICHERRY |
9443426244
drsanthoshsatheesh@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 20 |
| Name of Committee |
Approval Status |
| Drug Trial Ethics Comittee DMC |
Approved |
| Ethical Committee SCTIMST |
Submittted/Under Review |
| Ethical Committee SMS Medical college and Hospital |
Submittted/Under Review |
| Ethics Comittee Apollo Hospital Hyderabad |
Approved |
| Ethics Comittee Apollo Hospital, Chennai |
Approved |
| Ethics Comittee for Research Fortis Flt. Lt. Rajan Dhall |
Approved |
| Ethics Comittee Sir Ganga Ram Hospital |
Approved |
| Independent Ethics Comittee Fortis Escorts Heart Institute |
Approved |
| Institutional Ethics Comittee CARE Hospital, Banjara Hills |
Approved |
| Institutional Ethics Comittee CARE Hospital, Musheerabad |
Approved |
| Institutional Ethics Comittee CARE Hospital, Nampally |
Approved |
| Institutional Ethics Comittee Govt. Medical College, Calicut |
Approved |
| Institutional Ethics Comittee JIPMER |
Approved |
| Institutional Ethics Comittee KGMU |
Approved |
| Institutional Ethics Comittee MOSC |
Approved |
| Institutional Ethics Comittee Ruby Hall Clinic |
Approved |
| Institutional Ethics Committee AIIMS |
Approved |
| Institutional Ethics Committee RML |
Approved |
| KEM Hospital Research Centre, Ethics Comittee |
Approved |
| Sri Jayadeva Institution Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Cardiovascular Diseases,
Coronary Disease,
Coronary Artery Disease,
Heart Diseases,
Myocardial Ischemia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Invasive Strategy (INV)
Routine invasive strategy with cardiac catheterization followed by revascularization plus optimal medical therapy. |
Procedure: cardiac catheterization
Narrowed blood vessels can be opened without surgery using stents or can be bypassed with surgery. To determine which is the best approach for you the doctor needs to look at your blood vessels to see where the narrowings are and how much narrowing there is. This is done by a procedure known as a cardiac catheterization (cath).
Other Name: cath
Procedure: coronary artery bypass graft surgery
Artery narrowing is bypassed during surgery with a healthy artery or vein from another part of the body. This is known as coronary artery bypass grafting, or CABG (said, "cabbage"). The surgery creates new routes around narrowed and blocked heart arteries. This allows more blood flow to the heart.
Other Name: CABG
Procedure: percutaneous coronary intervention
Percutaneous coronary intervention (PCI) may be done as part of the cardiac catheterization procedure. With this procedure a small, hollow, mesh tube (stent) is inserted into the narrowed part of the artery. The stent pushes the plaque against the artery wall, and opens the vessel to allow better blood flow.
Other Name: PCI
Behavioral: Lifestyle
diet, physical activity, smoking cessation
Other Names:
Lifestyle
Behavioral Choices
Drug: Medication
antiplatelet, statin, other lipid lowering, antihypertensive, and anti-ischemic medical therapies
Other Name: Pharmacologic Therapy |
| Comparator Agent |
Conservative Strategy
Optimal medical therapy with cardiac catheterization and revascularization reserved for patients with acute coronary syndrome, ischemic heart failure, resuscitated cardiac arrest or refractory symptoms. |
Behavioral: Lifestyle
diet, physical activity, smoking cessation
Other Names:
Lifestyle
Behavioral Choices
Drug: Medication
antiplatelet, statin, other lipid lowering, antihypertensive, and anti-ischemic medical therapies
Other Name: Pharmacologic Therapy |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Participant is willing to give written informed consent
Age ≥ 21 years
At least moderate ischemia on a stress imaging test with nuclear myocardial perfusion |
|
| ExclusionCriteria |
| Details |
LVEF 35%
History of unprotected left main stenosis 50% on prior coronary computed tomography angiography (CCTA) or prior cardiac catheterization (if available).
Finding of "no obstructive CAD" (50% stenosis in all major epicardial vessels) on prior CCTA or prior catheterization, performed within 12 months
Prior known coronary anatomy unsuitable for either PCI or CABG
Unacceptable level of angina despite maximal medical therapy
Very dissatisfied with medical management of angina
History of noncompliance with medical therapy
Acute coronary syndrome within the previous 2 months
PCI or CABG within the previous 12 months
Stroke within the previous 6 months or intracranial hemorrhage at any time
History of ventricular tachycardia requiring therapy for termination, or symptomatic sustained ventricular tachycardia
NYHA class III-IV heart failure at entry or hospitalization for exacerbation of chronic heart failure within the previous 6 months
Non-ischemic dilated or hypertrophic cardiomyopathy
End stage renal disease on dialysis or estimated glomerular filtration rate (eGFR) 30mL/min
Severe valvular disease or valvular disease likely to require surgery within 5 years
Allergy to radiographic contrast that cannot be adequately pre-medicated, or any prior anaphylaxis to radiographic contrast
Planned major surgery necessitating interruption of dual antiplatelet therapy
Life expectancy less than 5 years due to non-cardiovascular comorbidity
Pregnancy (known to be pregnant; to be confirmed before CCTA and/or randomization, if applicable)
Enrolled in a competing trial that involves a non-approved cardiac drug or device
Inability to comply with the protocol
Exceeds the weight or size limits for CCTA or cardiac catheterization at the enrolling site
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time to first occurrence of cardiovascular death or nonfatal myocardial infarction |
Four year follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| ngina control per Seattle Angina Questionnaire (SAQ) Angina Frequency Scale |
Four year follow up |
| Disease specific quality of life per Seattle Angina Questionnaire (SAQ) Quality of Life Scale |
Four year follow up |
| Composite of cardiovascular death, nonfatal myocardial infarction, resuscitated cardiac arrest, or hospitalization for unstable angina or heart failure |
Four year follow up |
| Cardiovascular death |
Four year follow up |
| Nonfatal myocardial infarction |
Four year follow up |
| Resuscitated cardiac arrest |
Four year follow up |
| Hospitalization for unstable angina |
Four year follow up |
| Hospitalization for heart failure |
Four year follow up |
| Stroke |
Four year follow upv |
| Composite of cardiovascular death, nonfatal myocardial infarction, stroke, resuscitated cardiac arrest, hospitalization for unstable angina or heart failure |
Four year follow up |
| Health resource utilization, costs, and cost effectiveness |
Four year follow up |
|
|
Target Sample Size
|
Total Sample Size="8000"
Sample Size from India="1000"
Final Enrollment numbers achieved (Total)= "5179"
Final Enrollment numbers achieved (India)="941" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/05/2013 |
| Date of Study Completion (India) |
30/06/2019 |
| Date of First Enrollment (Global) |
02/07/2012 |
| Date of Study Completion (Global) |
30/06/2019 |
|
Estimated Duration of Trial
|
Years="7"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The purpose of the ISCHEMIA trial is to determine the best management strategy for higher-risk patients with stable ischemic
heart disease. This is a multicenter randomized controlled trial with a
target enrollment of ~8000 patients with at least moderate ischemia
on stress imaging. Patients will be assigned at random to a routine
invasive strategy (INV) with cardiac catheterization (cath) followed by
revascularization plus optimal medical therapy (OMT) or to a
conservative strategy (CON) of OMT, with cath and revascularization
reserved for those with an acute coronary syndrome, ischemic heart failure, resuscitated cardiac arrest or refractory symptoms |