This study is designed to determine the medical value of cardiac imaging tests to detect
coronary heart disease and predict future heart-related harmful events (such as heart
attacks). The reason for this study is that doctors have many cardiac imaging options to
help them diagnose coronary heart disease. These imaging modalities help doctors by
producing pictures of the heart that can show more information in regards to the health
status of the patient. However, these tests are expensive and therefore require an
investigation to determine if the costs for these tests are equal to their benefits.
SPARC will have two components consisting of a Pilot CT coronary angiographic study and a
Main study. The Pilot study will be completed to optimize imaging protocols, quality, and
interpretation of coronary CT angiographic studies across multiple study sites. The Main
study will be completed to assess the following specific objectives:
The primary objectives:
1. Assess the impact of Myocardial Perfusion (stress SPECT and stress PET), CT Coronary
Angiography (CTA), and combined Myocardial Perfusion-CTA Imaging (PET/CT) on post-test
2. Determine the incremental prognostic value of stress SPECT, stress PET, CTA, and PET/CT
for predicting cardiac death and nonfatal myocardial infarction following a procedure.
1. Assess the diagnostic accuracy of these modalities for detection of obstructive
epicardial coronary stenosis as assessed by cardiac catheterization.
2. Assess the risk-adjusted referral rate to revascularization within 90 days of cardiac
catheterization after the index noninvasive imaging study.
3. Assess the use of and change in cardiac medications at 90 days and one year after the
index noninvasive imaging study.
4. Determine the combined occurrence of (1) death from any cause, (2) nonfatal myocardial
infarction, and (3) late (>6 month) referral to revascularization after the index
noninvasive imaging study.
5. Determine the cost-effectiveness of strategies incorporating different noninvasive
- Referred for a clinical stress SPECT and stress PET study. Yale site will recruit
patient only in the SPECT and PET arms of the study.
- Intermediate to high pretest likelihood for CAD (>0.25; as defined by ACC/AHA Stable
Angina Guidelines) without prior MI or cardiac revascularization. These are
considered Diagnostic patients that will be included in the analysis of Primary
- Documented prior history of CAD as defined by a history of prior MI, coronary
revascularization, or cardiac catheterization with evidence of CAD. Patients with
documented prior CAD together with the Diagnostic Cohort will be included in the
analysis of Primary Objective 2.
- Provide signed informed consent to participate in the study.
- Low pretest likelihood for CAD (≤0.25; as defined by ACC/AHA Stable Angina
- Major concomitant noncardiac disease, which in the opinion of the investigator will
preclude the patient from participation in the study follow-up.
- Any social condition/situation that, in the opinion of the investigator, would
preclude follow-up during the course of the study.
- Concurrent or prior (within last 30 days) participation in other research studies
using investigational drugs or devices.
- Implantation 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.