Known CAD, or Intermediate-high Pretest Likelihood for CAD
Conditions
Keywords
CORONARY ANATOMY, Coronary Artery Disease, SPECT, PET, PET/CT, CTA
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.
Interventions
None listed
Sponsors
Brigham and Women's Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Countries
Canada, United States
Outcome results
None listed