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

This study is ongoing, but not recruiting participants.
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: May 14, 2013
Last verified: May 2013

May 1, 2006
May 14, 2013
June 2006
March 2010   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00321399 on ClinicalTrials.gov Archive Site
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Study of Perfusion and Anatomy's Role in Coronary Artery (CAD)
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

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.
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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

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

Known CAD, or Intermediate-high Pretest Likelihood for CAD
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Hachamovitch R, Johnson JR, Hlatky MA, Cantagallo L, Johnson BH, Coughlan M, Hainer J, Gierbolini J, Di Carli MF; SPARC Investigators. The study of myocardial perfusion and coronary anatomy imaging roles in CAD (SPARC): design, rationale, and baseline patient characteristics of a prospective, multicenter observational registry comparing PET, SPECT, and CTA for resource utilization and clinical outcomes. J Nucl Cardiol. 2009 Nov-Dec;16(6):935-48.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
3000
August 2014
March 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00321399
SPARC
No
Marcelo F. Di Carli, MD, FACC, Brigham and Women's Hospital
Brigham and Women's Hospital
Not Provided
Principal Investigator: Marcelo F Di Carli, MD FACC Brigham and Women's Hospital
Principal Investigator: Rory Hachamovitch, MD Msc FACC University of Southern California
Brigham and Women's Hospital
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP