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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000026116
Receipt No. R000030012
Scientific Title International Study of Comparative Health Effectiveness with Medical and Invasive Approaches
Date of disclosure of the study information 2017/02/13
Last modified on 2017/02/13

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Basic information
Public title International Study of Comparative Health Effectiveness with Medical and Invasive Approaches
Acronym ISCHEMIA Trial
Scientific Title International Study of Comparative Health Effectiveness with Medical and Invasive Approaches
Scientific Title:Acronym 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
1st name
Middle name
Last name Judith S Hochman, MD
Organization New York University, School of Medicine
Division name Senior associate dean for Clinical Sciences
Zip code
Address 550 1st Ave, New York, NY 10016 USA
TEL +1-212-263-5290
Email ischemia@nyumc.org

Public contact
Name of contact person
1st name
Middle name
Last name Shun Kohsaka
Organization Keio University School of Medicine
Division name Department of Cardiology
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2011 Year 10 Month 11 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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