Study of Perfusion and Anatomy's Role in Coronary Artery (CAD) (SPARC)
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Purpose
Three main clinical outcomes will be assessed:
- Post-test resource utilization as assessed by referral rate to catheterization within 90-days of the index study;
- Incremental prognostic value and risk stratification for predicting cardiac death and myocardial infarction;
- 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:
- 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;
- 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:
- 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;
- 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.
| Condition |
|---|
|
Known CAD, or Intermediate-high Pretest Likelihood for CAD |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | SPARC, Including Its Pilot CT Angiographic Study, is a Prospective, Open-label, Multicenter, Sequentially Sampled, Observational Registry to Define the Clinical Value of Stress Perfusion (Stress SPECT, Stress PET), Noninvasive Angiography (CTA) and Combined Perfusion-anatomy (PET/CT) Studies in Patients With Known or Suspected CAD With Respect to Post-test Resource Utilization and Prediction of Cardiac Death and Non-fatal Myocardial Infarction |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients with known coronary artery disease and patients with suspected CAD and an intermediate-High Likelihood of disease
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
Contacts and Locations
Show 41 Study Locations| Principal Investigator: | Marcelo F Di Carli, MD FACC | Brigham and Women's Hospital |
| Principal Investigator: | Rory Hachamovitch, MD Msc FACC | University of Southern California |
More Information
No publications provided by Brigham and Women's Hospital
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Marcelo F. Di Carli, MD, FACC, Chief, Division of Nuclear Medicine, Brigham and Women's Hospital |
| ClinicalTrials.gov Identifier: | NCT00321399 History of Changes |
| Other Study ID Numbers: | SPARC |
| Study First Received: | May 1, 2006 |
| Last Updated: | May 14, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Brigham and Women's Hospital:
|
CORONARY ANATOMY Coronary Artery Disease SPECT |
PET PET/CT CTA |
Additional relevant MeSH terms:
|
Myocardial Infarction Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on May 22, 2013