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Clinical Trials

Topic   Cardiology
Title   International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA)
Summary   The purpose of this study is to determine the best way to manage stable ischemic (too little blood flow to the heart) heart disease.
Description   Eligible patients will be recruited after a having a stress imaging test that was necessary for their routine care, that was ordered by their physician if they are found to have at least moderate ischemia (decreased blood flow to the heart muscle) on the test. Patients will then be assigned to one of two groups, based on a “flip of the coin” process called, randomization. Both groups will have cardiac catheterization (a test to evaluate the condition of the coronary arteries) and both groups will also have optimal medical therapy (prescribed medication) treatment. The invasive management group (INV) participants will receive a coronary revascularization procedure. Coronary revascularization is the process of restoring the flow of blood to the heart. This is done by removing or bypassing (going around) blockages in coronary arteries caused by atherosclerosis (the build-up of plaque in the inner lining of an artery). The conservative group (CON) participants will possibly receive a coronary revascularization procedure but only if the participant is not responding to optimal medical therapy. Researchers will evaluate data about occurrence of major adverse cardiac events (heart attack, death) in both groups. They will also look at control of angina (chest pain) and participant’s quality of life, as measured by questionnaire. Other issues such as health resource utilization, cost, and cost-effectiveness will be compared between the two management strategies.
IRB Number   13010
Inclusion/Notes   At least moderate ischemia found on stress testing, age over 21 years, willing and able provide informed consent and comply with the research study protocol.
Principal Name   Kevin Marzo, MD
Contact Name   Wendy Drewes, BSN, RN, CCRC (wdrewes@nyuwinthrop.org)
Email   kmarzo@nyuwinthrop.org
Phone   516-663-2396
Alternate Phone   516-663-2929