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CompletedNCT00321399SPARCUpdated Jul 16, 2014

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

An observational study in Known CAD, or Intermediate-high Pretest Likelihood for CAD, sponsored by Brigham and Women's Hospital. Completed at 41 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-07-16.

Sponsored by Brigham and Women's Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
3,019
Ages
18 Years and older
Sex
All
01

Study summary

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.
02

Conditions studied

  • Known CAD, or Intermediate-high Pretest Likelihood for CAD

Keywords

  • CORONARY ANATOMY
  • Coronary Artery Disease
  • SPECT
  • PET
  • PET/CT
  • CTA
03

In context

Lead sponsor

Brigham and Women's Hospital is the lead sponsor of 1,236 studies on the registry; 224 are open to participants now.

Of its 116 completed or terminated interventional studies of FDA-regulated products, 64 (55%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
3,019 participants (actual)
06

Study locations

41 sites
  • Cardiovascular Associates
    Birmingham, Alabama 35213, United States
  • University of Alabama at Birmingham
    Birmingham, Alabama 35294, United States
  • The Heart Center
    Huntsville, Alabama 35801, United States
  • Scottsdale Medical Imaging
    Scottsdale, Arizona 85252, United States
  • Scripps Center for Integrative Medicine
    La Jolla, California 92037, United States
  • Cedars-Sinai Medical Center
    Los Angeles, California 90048, United States
  • University of California Irvine Medical Center
    Orange, California 92868, United States
  • Los Angeles Biomedical Research Inst.
    Torrance, California 90502, United States
  • Hartford Hospital
    Hartford, Connecticut 06102, United States
  • Yale - New Haven VA Hospital
    New Haven, Connecticut 06520, United States
  • Cardiac Specialists
    Trumbull, Connecticut 06611, United States
  • Washington Hospital Center
    Washington, District of Columbia 20010, United States
  • University of Florida - Jacksonville
    Jacksonville, Florida 32209, United States
  • Emory Crawford Long Hospital
    Atlanta, Georgia 30308, United States
  • Fugua Heart Center - Piedmont Hospital
    Atlanta, Georgia 30309, United States
  • University of Chicago
    Chicago, Illinois 60637, United States
  • Sinai Hosptial of Baltimore
    Baltimore, Maryland 21215, United States
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
  • Brigham and Women's Hosptial
    Boston, Massachusetts 02115, United States
  • Lahey Clinic
    Burlington, Massachusetts 01805, United States
  • University of Michigan
    Ann Arbor, Michigan 48109, United States
  • Minneapolis Heart Inst.
    Minneapolis, Minnesota 55407, United States
  • Mayo Clinic
    Rochester, Minnesota 55902, United States
  • Holy Name Hospital
    Teaneck, New Jersey 07666, United States
  • Montefiore Medical Center
    Bronx, New York 10461, United States
  • North Shore University Hospital
    Manhasset, New York 11030, United States
  • NYU Medical Center
    New York, New York 10016, United States
  • Mount Sinai Medical Center
    New York, New York 10029, United States
  • Columbia University Medical Center
    New York, New York 10032, United States
  • St. Francis Hospital - The Heart Center
    Roslyn, New York 11576, United States
  • Duke University Medical Center
    Durham, North Carolina 27710, United States
  • Meritcare Hospital
    Fargo, North Dakota 58122, United States
  • Cleveland Clinic Foundation
    Cleveland, Ohio 44145, United States
  • Ohio State University Medical Center
    Columbus, Ohio 43210, United States
  • Oklahoma Foundation for Cardiovascular Research
    Oklahoma City, Oklahoma 73120, United States
  • Rhode Island Hospital
    Providence, Rhode Island 02903, United States
  • Medical University of South Carolina
    Charleston, South Carolina 29425, United States
  • Tennessee Heart and Vascular Inst.
    Hendersonville, Tennessee 37075, United States
  • University of Washington Cardiology & Nuclear Medicine
    Seattle, Washington 98195, United States
  • Wisconsin Heart Hospital
    Milwaukee, Wisconsin 53226, United States
  • University of Ottawa Heart Institute
    Ottawa, Ontario K1Y4E9, Canada
07

References and documents

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. PubMed 22281249 ↗
  • 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. PubMed 19760338 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 16, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00321399
Lead sponsor
Brigham and Women's Hospital
Responsible party
Marcelo F. Di Carli, MD, FACC (Chief, Division of Nuclear Medicine, Brigham and Women's Hospital) — Principal investigator
First posted
May 3, 2006
Start date
Jun 2006
Primary completion
Mar 2010
Completion
Jul 2014
Last update
Jul 16, 2014

Study contacts

Marcelo F Di Carli, MD FACC
principal investigator · Brigham and Women's Hospital
Rory Hachamovitch, MD Msc FACC
principal investigator · University of Southern California

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.

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