Trial record 3 of 20 for:    cardiac catheterization | Open Studies | NIH, U.S. Fed

International Study of Comparative Health Effectiveness With Medical and Invasive Approaches (ISCHEMIA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by New York University School of Medicine
Sponsor:
Collaborators:
New York University
Stanford University
Albany Stratton VA Medical Center
Cedars-Sinai Medical Center
Columbia University
Duke University
East Carolina University
Emory University
Harvard University
Massachusetts General Hospital
Montreal Heart Institute
University of British Columbia
University of Missouri, Kansas City
Vanderbilt University
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01471522
First received: November 10, 2011
Last updated: April 3, 2014
Last verified: April 2014
  Purpose

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 who fail OMT.

SPECIFIC AIMS

A. Primary Aim The primary aim of the ISCHEMIA trial is to determine whether an initial invasive strategy of cardiac catheterization followed by optimal revascularization, if feasible, in addition to OMT, will reduce the primary composite endpoint of cardiovascular death or nonfatal myocardial infarction in participants with SIHD and at least moderate ischemia over an average follow-up of approximately 4 years compared with an initial conservative strategy of OMT alone with catheterization reserved for failure of OMT. The primary endpoint is time to centrally adjudicated cardiovascular death or nonfatal myocardial infarction.

B. Secondary Aims Major: To compare angina-related quality of life between groups. Other secondary aims include: a) comparing the incidence of all-cause death; the components of the primary endpoint; the composite endpoint of cardiovascular death, myocardial infarction, or hospitalization for unstable angina, resuscitated cardiac arrest, or heart failure; stroke; and stroke combined with cardiovascular death, myocardial infarction, or hospitalization for unstable angina, resuscitated cardiac arrest, or heart failure between randomized groups; and b) comparing health resource utilization, costs, and cost-effectiveness between groups.

Condition: Coronary Disease Procedure: Coronary CT Angiogram Procedure: Cardiac catheterization Phase: Phase III

Condition: Cardiovascular Diseases Procedure: Angioplasty, Transluminal, Percutaneous Coronary, other catheter-based interventions Phase: Phase III

Condition: Heart Diseases Procedure: Coronary Artery Bypass Surgery Phase: Phase III


Condition Intervention
Cardiovascular Diseases
Coronary Disease
Coronary Artery Disease
Heart Diseases
Myocardial Ischemia
Procedure: cardiac catheterization
Procedure: coronary artery bypass graft surgery
Procedure: percutaneous coronary intervention
Behavioral: Lifestyle
Drug: Medication

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: International Study of Comparative Health Effectiveness With Medical and Invasive Approaches (ISCHEMIA)

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • Time to first occurrence of cardiovascular death or nonfatal myocardial infarction. [ Time Frame: ~four year follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Angina control per Seattle Angina Questionnaire (SAQ) Angina Frequency Scale [ Time Frame: mean ~four year follow-up ] [ Designated as safety issue: No ]
  • Disease specific quality of life per Seattle Angina Questionnaire (SAQ) Quality of Life Scale [ Time Frame: mean ~four year follow-up ] [ Designated as safety issue: No ]
  • Composite of cardiovascular death, nonfatal myocardial infarction, resuscitated cardiac arrest, or hospitalization for unstable angina or heart failure [ Time Frame: mean ~four year follow-up ] [ Designated as safety issue: No ]
  • Cardiovascular death [ Time Frame: mean ~four year follow-up ] [ Designated as safety issue: No ]
  • Nonfatal myocardial infarction [ Time Frame: mean ~four year follow-up ] [ Designated as safety issue: No ]
  • Resuscitated cardiac arrest [ Time Frame: mean ~four year follow-up ] [ Designated as safety issue: No ]
  • Hospitalization for unstable angina [ Time Frame: mean ~four year follow-up ] [ Designated as safety issue: No ]
  • Hospitalization for heart failure [ Time Frame: mean ~four year follow-up ] [ Designated as safety issue: No ]
  • Stroke [ Time Frame: mean ~four year follow-up ] [ Designated as safety issue: No ]
  • Composite of cardiovascular death, nonfatal myocardial infarction, stroke, resuscitated cardiac arrest, hospitalization for unstable angina or heart failure. [ Time Frame: mean ~four year follow-up ] [ Designated as safety issue: No ]
  • Health resource utilization, costs, and cost effectiveness [ Time Frame: mean ~four year follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 8000
Study Start Date: July 2012
Estimated Study Completion Date: May 2019
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least moderate ischemia on an ischemia test
  • Participant is willing to comply with all aspects of the protocol, including adherence to the assigned strategy, medical therapy and follow-up visits
  • Participant is willing to give written informed consent
  • Age ≥ 21 years

Exclusion Criteria:

  • 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
  • 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 within the previous 12 months
  • Stroke within the previous 6 months or spontaneous intracranial hemorrhage at any time
  • History of ventricular tachycardia requiring therapy for termination, or symptomatic sustained ventricular tachycardia not due to a transient reversible cause
  • 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 (not an exclusion criterion for CKD ancillary trial, see CKD ancillary trial, Section 18)
  • Severe valvular disease or valvular disease likely to require surgery or percutaneous valve replacement during the trial
  • 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 (note that patients may be eligible after planned surgery)
  • Life expectancy less than the duration of the trial due to non-cardiovascular comorbidity
  • Pregnancy (known to be pregnant; to be confirmed before CCTA and/or randomization, if applicable)
  • 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)
  • 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 limit for CCTA or cardiac catheterization at the site
  • Canadian Cardiovascular Society Class III angina of recent onset, OR angina of any class with a rapidly progressive or accelerating pattern
  • Canadian Cardiovascular Society Class IV angina, including unprovoked rest angina
  • High risk of bleeding which would contraindicate the use of dual antiplatelet therapy
  • Cardiac transplant recipient
  • 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01471522

Contacts
Contact: Judith S Hochman, MD 212-263-4225 ISCHEMIA@nyumc.org
Contact: Stephanie Mavromichalis 212-263-4225 ISCHEMIA@nyumc.org

  Show 221 Study Locations
Sponsors and Collaborators
New York University School of Medicine
New York University
Stanford University
Albany Stratton VA Medical Center
Cedars-Sinai Medical Center
Columbia University
Duke University
East Carolina University
Emory University
Harvard University
Massachusetts General Hospital
Montreal Heart Institute
University of British Columbia
University of Missouri, Kansas City
Vanderbilt University
Investigators
Study Chair: Judith S Hochman, MD New York University
Principal Investigator: David J Maron, MD Stanford University
  More Information

Additional Information:
Publications:
Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT01471522     History of Changes
Other Study ID Numbers: 713, 1U01HL105907
Study First Received: November 10, 2011
Last Updated: April 3, 2014
Health Authority: United States: Data and Safety Monitoring Board
United States: Institutional Review Board
United States: Federal Government

Additional relevant MeSH terms:
Cardiovascular Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Ischemia
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014