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

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.

Study Overview

• Status: Completed
• Conditions: Known CAD, or Intermediate-high Pretest Likelihood for CAD

• Study Type: Observational
• Enrollment (Actual): 3019

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1Y4E9
      • University of Ottawa Heart Institute
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham
    • Birmingham, Alabama, United States, 35213
      • Cardiovascular Associates
    • Huntsville, Alabama, United States, 35801
      • The Heart Center
  • Arizona
    • Scottsdale, Arizona, United States, 85252
      • Scottsdale Medical Imaging
  • California
    • La Jolla, California, United States, 92037
      • Scripps Center for Integrative Medicine
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center
    • Orange, California, United States, 92868
      • University of California Irvine Medical Center
    • Torrance, California, United States, 90502
      • Los Angeles Biomedical Research Inst.
  • Connecticut
    • Hartford, Connecticut, United States, 06102
      • Hartford Hospital
    • New Haven, Connecticut, United States, 06520
      • Yale - New Haven VA Hospital
    • Trumbull, Connecticut, United States, 06611
      • Cardiac Specialists
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Washington Hospital Center
  • Florida
    • Jacksonville, Florida, United States, 32209
      • University of Florida - Jacksonville
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • Emory Crawford Long Hospital
    • Atlanta, Georgia, United States, 30309
      • Fugua Heart Center - Piedmont Hospital
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago
  • Maryland
    • Baltimore, Maryland, United States, 21215
      • Sinai Hosptial of Baltimore
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hosptial
    • Burlington, Massachusetts, United States, 01805
      • Lahey Clinic
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Minneapolis Heart Inst.
    • Rochester, Minnesota, United States, 55902
      • Mayo Clinic
  • New Jersey
    • Teaneck, New Jersey, United States, 07666
      • Holy Name Hospital
  • New York
    • Bronx, New York, United States, 10461
      • Montefiore Medical Center
    • Manhasset, New York, United States, 11030
      • North Shore University Hospital
    • New York, New York, United States, 10032
      • Columbia University Medical Center
    • New York, New York, United States, 10029
      • Mount Sinai Medical Center
    • New York, New York, United States, 10016
      • NYU Medical Center
    • Roslyn, New York, United States, 11576
      • St. Francis Hospital - The Heart Center
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
  • North Dakota
    • Fargo, North Dakota, United States, 58122
      • Meritcare Hospital
  • Ohio
    • Cleveland, Ohio, United States, 44145
      • Cleveland Clinic Foundation
    • Columbus, Ohio, United States, 43210
      • Ohio State University Medical Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73120
      • Oklahoma Foundation for Cardiovascular Research
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • Tennessee
    • Hendersonville, Tennessee, United States, 37075
      • Tennessee Heart and Vascular Inst.
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington Cardiology & Nuclear Medicine
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Wisconsin Heart Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General Publications

• Hachamovitch R, Nutter B, Hlatky MA, Shaw LJ, Ridner ML, Dorbala S, Beanlands RS, Chow BJ, Branscomb E, Chareonthaitawee P, Weigold WG, Voros S, Abbara S, Yasuda T, Jacobs JE, Lesser J, Berman DS, Thomson LE, Raman S, Heller GV, Schussheim A, Brunken R, Williams KA, Farkas S, Delbeke D, Schoepf UJ, Reichek N, Rabinowitz S, Sigman SR, Patterson R, Corn CR, White R, Kazerooni E, Corbett J, Bokhari S, Machac J, Guarneri E, Borges-Neto S, Millstine JW, Caldwell J, Arrighi J, Hoffmann U, Budoff M, Lima J, Johnson JR, Johnson B, Gaber M, Williams JA, Foster C, Hainer J, Di Carli MF; SPARC Investigators. Patient management after noninvasive cardiac imaging results from SPARC (Study of myocardial perfusion and coronary anatomy imaging roles in coronary artery disease). J Am Coll Cardiol. 2012 Jan 31;59(5):462-74. doi: 10.1016/j.jacc.2011.09.066.
• 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. doi: 10.1007/s12350-009-9140-7.

Study record dates

Study Major Dates

• Study Start: June 1, 2006
• Primary Completion (Actual): March 1, 2010
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: May 1, 2006
• First Submitted That Met QC Criteria: May 1, 2006
• First Posted (Estimate): May 3, 2006

Study Record Updates

• Last Update Posted (Estimate): July 16, 2014
• Last Update Submitted That Met QC Criteria: July 15, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: PET/CT; Coronary Artery Disease; PET; SPECT; CTA; CORONARY ANATOMY
• Other Study ID Numbers: SPARC