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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Marcelo F. Di Carli, MD, FACC, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00321399
First received: May 1, 2006
Last updated: July 15, 2014
Last verified: July 2014
  Purpose

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.

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

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Enrollment: 3019
Study Start Date: June 2006
Study Completion Date: July 2014
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with known coronary artery disease and patients with suspected CAD and an intermediate-High Likelihood of disease

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00321399

  Show 41 Study Locations
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
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: July 15, 2014
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

ClinicalTrials.gov processed this record on October 20, 2014