Study of Perfusion and Anatomy's Role in Coronary Artery (CAD)

Completed

Conditions studied: Known CAD, or Intermediate-high Pretest Likelihood for CAD

In brief

Three main clinical outcomes will be assessed: 1. Post-test resource utilization as assessed by referral rate to catheterization within 90-days of the index study; 2. Incremental prognostic value and risk stratification for predicting cardiac death and myocardial infarction; 3. Cost-effectiveness To this end, SPARC is organized with two distinct specific objectives with important differences in patient population and endpoints. Specific Aim 1: To evaluate the impact of stress perfusion imaging with SPECT or PET, CT Angiography, and hybrid PET-CT on post-test resource utilization. The primary endpoint of specific aim 1 is to compare the impact of combined myocardial perfusion-coronary anatomy data to that of perfusion only \[stress SPECT, stress cardiac PET (without CTA)\] and anatomy only (CTA alone) on post-test resource utilization, as measured by referral to cardiac catheterization within 90 days of index noninvasive testing, in patients without CAD. Secondary endpoints: 1. to compare the diagnostic accuracy for detection of epicardial CAD of stress PET and hybrid PET-CT, stress SPECT, and CTA, as defined by coronary angiography; 2. to compare the referral rate to revascularization within 90 days of cardiac catheterization. Specific Aim 2: To compare the incremental prognostic value and risk stratification of stress perfusion imaging with SPECT or PET, CT coronary angiography, and combined perfusion-anatomy imaging approaches. The primary endpoint of specific aim 2 is to compare the incremental value of stress perfusion only (stress PET and stress SPECT), coronary anatomy only (CTA data), and combined perfusion-anatomy studies (PET+CTA and SPECT+CTA) over clinical, historical and stress test data for the prediction of cardiac death and nonfatal myocardial infarction. Secondary endpoints: 1. to compare the incremental value of these noninvasive imaging approaches over clinical, historical and stress test data for the prediction of a composite endpoint including cardiac death, nonfatal myocardial infarction, late (\>6 month from index study) referral to revascularization, or late (\>6 month from index study) hospitalization for chest pain or heart failure; 2. to compare the incremental value of these noninvasive imaging approaches over clinical, historical and stress test data for the prediction of all cause mortality. In addition, the ability of these modalities -together and separately- to risk stratify patients is a primary goal of specific aim 2.

Key facts

Study ID

NCT00321399

Run by

Brigham and Women's Hospital

People needed

3019

Starts

2006-06-01

Expected to finish

2014-07-01

Last updated by the study team

2014-07-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Referred for a clinical stress SPECT, stress PET, CTA or PET-CT study
• Intermediate to high pretest likelihood for CAD (>.25;as defined by ACC/AHA Stable Angina Guidelines) without prior MI/PCI/CABG. These are considered diagnostic patients.
• or
• Documented known CAD as defined by prior MI/PCI/CABG
• Provide signed informed consent to participate in the study

You may not qualify if…

• Low pretest likelihood for CAD (<=.25; as defined by ACC/AHA Stable Angina Guidelines).
• Major concomitant noncardiac disease or social condition/situation that in the opinion of the investigator will preclude the patient from participation in the study follow-up.
• Concurrent or prior(within last 30 days) participation in other research studies using investigational drugs or devices.
• Presence of a permanent automated internal cardiac defibrillator (AICD)
• Known non-ischemic cardiomyopathy
• Chest pain at rest within 48 hours prior to the index noninvasive imaging test

Where it is running

• Cardiovascular Associates — Birmingham, Alabama, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States
• The Heart Center — Huntsville, Alabama, United States
• Scottsdale Medical Imaging — Scottsdale, Arizona, United States
• Scripps Center for Integrative Medicine — La Jolla, California, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• University of California Irvine Medical Center — Orange, California, United States
• Los Angeles Biomedical Research Inst. — Torrance, California, United States
• Hartford Hospital — Hartford, Connecticut, United States
• Yale - New Haven VA Hospital — New Haven, Connecticut, United States
• Cardiac Specialists — Trumbull, Connecticut, United States
• Washington Hospital Center — Washington D.C., District of Columbia, United States
• University of Florida - Jacksonville — Jacksonville, Florida, United States
• Emory Crawford Long Hospital — Atlanta, Georgia, United States
• Fugua Heart Center - Piedmont Hospital — Atlanta, Georgia, United States
• University of Chicago — Chicago, Illinois, United States
• Sinai Hosptial of Baltimore — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Brigham and Women's Hosptial — Boston, Massachusetts, United States
• Lahey Clinic — Burlington, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Minneapolis Heart Inst. — Minneapolis, Minnesota, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Holy Name Hospital — Teaneck, New Jersey, United States
• North Shore University Hospital — Manhasset, New York, United States

Full record on ClinicalTrials.gov

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