UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	International Study of Comparative Health Effectiveness with Medical and Invasive Approaches
Title of the study (Brief title)	ISCHEMIA Trial
Region	Japan Asia(except Japan) North America South America Australia Europe Africa

Condition
Condition	Stable Ischemic Heart Disease (SIHD)
Classification by specialty	Medicine in general Cardiology Cardiovascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	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 ~5000 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 who fail OMT.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Time to first occurrence of cardiovascular death or nonfatal myocardial infarction. [Time Frame:four year follow-up]
Key secondary outcomes	Composite of cardiovascular death, nonfatal myocardial infarction, resuscitated cardiac arrest, or hospitalization for unstable angina or heart failure [Time Frame: mean three year follow-up]

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine Device,equipment Behavior,custom
Interventions/Control_1	Active Comparator: 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. 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 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 Name: Behavior change Drug: Medication antiplatelet, statin, other lipid lowering, antihypertensive, and anti-ischemic medical therapies Other Name: Pharmacologic Therapy
Interventions/Control_2	Active Comparator: 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 Name: Behavior change Drug: Medication antiplatelet, statin, other lipid lowering, antihypertensive, and anti-ischemic medical therapies Other Name: Pharmacologic Therapy
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	21 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. At least moderate ischemia on an ischemia test 2. Participant is willing to comply with all aspects of the protocol, including adherence to the assigned strategy, medical therapy and follow-up visits 3. Participant is willing to give written informed consent 4. Age > 21 years
Key exclusion criteria	Continued 19. Pregnancy (known to be pregnant; to be confirmed before CCTA and/or randomization, if applicable). 20.Patient who, in the judgment of the patient's physician, is likely to have significant unprotected left main stenosis (Those who are able to undergo CCTA will have visual assessment of the left main coronary artery by the CCTA core lab). 21. Enrolled in a competing trial that involves a non-approved cardiac drug or device. 22. Inability to comply with the protocol. 23.Exceeds the weight or size limit for CCTA or cardiac catheterization at the site. 24. Canadian Cardiovascular Society Class III angina of recent onset, OR angina of any class with a rapidly progressive or accelerating pattern. 25. Canadian Cardiovascular Society Class IV angina, including unprovoked rest angina. 26. High risk of bleeding which would contraindicate the use of dual anti platelet therapy. 27. Cardiac transplant recipient. 28. Prior CABG, unless CABG was performed more than 12 months ago, and coronary anatomy has been demonstrated to be suitable for PCI or repeat CABG to accomplish complete revascularization of ischemic areas (CCC approval required).
Target sample size	5000

Research contact person
Name of lead principal investigator	Judith S Hochman, MD
Organization	New York University, School of Medicine
Division name	Senior associate dean for Clinical Sciences
Address	550 1st Ave, New York, NY 10016 USA
TEL	+1-212-263-5290
Email	ischemia@nyumc.org

Public contact
Name of contact person	Shun Kohsaka
Organization	Keio University School of Medicine
Division name	Department of Cardiology
Address	35, Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL	03-5843-6702
Homepage URL
Email	sk@z3.keio.jp

Sponsor
Institute	New York University, School of Medicine
Institute
Department

Funding Source
Organization	National Institutes of Health (NIH)
Organization
Division
Category of Funding Organization	Outside Japan
Nationality of Funding Organization	The United States of America

Other related organizations
Co-sponsor	New York University School of Medicine New York University Stanford University National Heart, Lung, and Blood Institute (NHLBI) Albany Stratton VA Medical Center Cedars-Sinai Medical Center
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	YES
Study ID_1	NCT01471522
Org. issuing International ID_1	Clinical Trials.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	国立循環器病研究センター(大阪府) 埼玉医科大学病院(埼玉県)

Other administrative information
Date of disclosure of the study information	2017 Year 02 Month 13 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2011 Year 10 Month 11 Day
Anticipated trial start date	2012 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 02 Month 13 Day
Last modified on	2017 Year 02 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030012