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

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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Key information

Conditions

Known CAD, or Intermediate-high Pretest Likelihood for CAD Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Ottawa Heart Institute, Ottawa, Ontario, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

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

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Official study 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

Acronym: SPARC

Important dates

Study start: 2006
Primary completion: 2010
Study completion: 2014
First posted: May 3, 2006
Registry last updated: Jul 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed