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New Haven, Connecticut 06520


Purpose:

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.


Study summary:

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 resource utilization. 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. Secondary objectives: 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 imaging modalities.


Criteria:

Inclusion Criteria: - 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 Objective 1. - 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. Exclusion Criteria: - Low pretest likelihood for CAD (≤0.25; as defined by ACC/AHA Stable Angina Guidelines). - 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.


NCT ID:

NCT00575289


Primary Contact:

Principal Investigator
Aseem Vashist, MD
Yale University


Backup Contact:

N/A


Location Contact:

New Haven, Connecticut 06520
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 17, 2017

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