UMIN-CTR Clinical Trial

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

Stable Ischemic Heart Disease (SIHD)

Classification by specialty

Medicine in general	Cardiology	Cardiovascular surgery

Classification by malignancy

Others

Genomic information

NO

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

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]

Study type

Interventional

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

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

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

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

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

Institute

New York University, School of Medicine

Institute

Department

Personal name

Organization

National Institutes of Health (NIH)

Organization

Division

Category of Funding Organization

Outside Japan

Nationality of Funding Organization

The United States of America

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)

Organization

Address

Tel

Email

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

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)

Date of disclosure of the study information

2017

Year

02

Month

13

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2017

Year

02

Month

13

Day

Last modified on

2017

Year

02

Month

13

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030012