Study of Perfusion and Anatomy's Role in Coronary Artery (CAD) (SPARC)
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|ClinicalTrials.gov Identifier: NCT00321399|
Recruitment Status : Completed
First Posted : May 3, 2006
Last Update Posted : July 16, 2014
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;
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.
- 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.
- 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 or disease|
|Known CAD, or Intermediate-high Pretest Likelihood for CAD|
|Study Type :||Observational|
|Actual Enrollment :||3019 participants|
|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|
|Study Start Date :||June 2006|
|Actual Primary Completion Date :||March 2010|
|Actual Study Completion Date :||July 2014|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00321399
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|