Study of Perfusion and Anatomy's Role in Coronary Artery (CAD)
- Conditions
- Known CAD, or Intermediate-high Pretest Likelihood for CAD
- Registration Number
- NCT00321399
- Lead Sponsor
- Brigham and Women's Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3019
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (41)
Scripps Center for Integrative Medicine
🇺🇸La Jolla, California, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
Lahey Clinic
🇺🇸Burlington, Massachusetts, United States
Ohio State University Medical Center
🇺🇸Columbus, Ohio, United States
Sinai Hosptial of Baltimore
🇺🇸Baltimore, Maryland, United States
North Shore University Hospital
🇺🇸Manhasset, New York, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Los Angeles Biomedical Research Inst.
🇺🇸Torrance, California, United States
The Heart Center
🇺🇸Huntsville, Alabama, United States
University of California Irvine Medical Center
🇺🇸Orange, California, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Scottsdale Medical Imaging
🇺🇸Scottsdale, Arizona, United States
Mount Sinai Medical Center
🇺🇸New York, New York, United States
Cardiovascular Associates
🇺🇸Birmingham, Alabama, United States
Hartford Hospital
🇺🇸Hartford, Connecticut, United States
Fugua Heart Center - Piedmont Hospital
🇺🇸Atlanta, Georgia, United States
Minneapolis Heart Inst.
🇺🇸Minneapolis, Minnesota, United States
University of Ottawa Heart Institute
🇨🇦Ottawa, Ontario, Canada
Holy Name Hospital
🇺🇸Teaneck, New Jersey, United States
Yale - New Haven VA Hospital
🇺🇸New Haven, Connecticut, United States
Oklahoma Foundation for Cardiovascular Research
🇺🇸Oklahoma City, Oklahoma, United States
Meritcare Hospital
🇺🇸Fargo, North Dakota, United States
Tennessee Heart and Vascular Inst.
🇺🇸Hendersonville, Tennessee, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Cardiac Specialists
🇺🇸Trumbull, Connecticut, United States
St. Francis Hospital - The Heart Center
🇺🇸Roslyn, New York, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Wisconsin Heart Hospital
🇺🇸Milwaukee, Wisconsin, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Brigham and Women's Hosptial
🇺🇸Boston, Massachusetts, United States
University of Washington Cardiology & Nuclear Medicine
🇺🇸Seattle, Washington, United States
NYU Medical Center
🇺🇸New York, New York, United States
University of Florida - Jacksonville
🇺🇸Jacksonville, Florida, United States
Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
Emory Crawford Long Hospital
🇺🇸Atlanta, Georgia, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States