Clinical trial NCT00321399: Study of Perfusion and Anatomy's Role in Coronary Artery (CAD)
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Known CAD, or Intermediate-high Pretest Likelihood for CAD
Keywords: CORONARY ANATOMY
Coronary Artery Disease
SPECT
PET
PET/CT
CTA
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2006-05-03
Enrollment: 3019
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief 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.


Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Cardiovascular Associates
state: Alabama
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Huntsville
country: United States
facility: The Heart Center
state: Alabama
city: Scottsdale
country: United States
facility: Scottsdale Medical Imaging
state: Arizona
city: La Jolla
country: United States
facility: Scripps Center for Integrative Medicine
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Orange
country: United States
facility: University of California Irvine Medical Center
state: California
city: Torrance
country: United States
facility: Los Angeles Biomedical Research Inst.
state: California
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: New Haven
country: United States
facility: Yale - New Haven VA Hospital
state: Connecticut
city: Trumbull
country: United States
facility: Cardiac Specialists
state: Connecticut
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Jacksonville
country: United States
facility: University of Florida - Jacksonville
state: Florida
city: Atlanta
country: United States
facility: Emory Crawford Long Hospital
state: Georgia
city: Atlanta
country: United States
facility: Fugua Heart Center - Piedmont Hospital
state: Georgia
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Baltimore
country: United States
facility: Sinai Hosptial of Baltimore
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hosptial
state: Massachusetts
city: Burlington
country: United States
facility: Lahey Clinic
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Minneapolis
country: United States
facility: Minneapolis Heart Inst.
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Teaneck
country: United States
facility: Holy Name Hospital
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
city: New York
country: United States
facility: NYU Medical Center
state: New York
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Roslyn
country: United States
facility: St. Francis Hospital - The Heart Center
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Fargo
country: United States
facility: Meritcare Hospital
state: North Dakota
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Foundation for Cardiovascular Research
state: Oklahoma
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Hendersonville
country: United States
facility: Tennessee Heart and Vascular Inst.
state: Tennessee
city: Seattle
country: United States
facility: University of Washington Cardiology & Nuclear Medicine
state: Washington
city: Milwaukee
country: United States
facility: Wisconsin Heart Hospital
state: Wisconsin
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
Study officials:
affiliation: Brigham and Women's Hospital
name: Marcelo F Di Carli, MD FACC
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Southern California
name: Rory Hachamovitch, MD Msc FACC
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.