PET MYOCARDIAL Blood Flow Comparison to Coronary CTA and CT-FFR

Study Overview
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Brief Summary
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The broad, long-term objective of this pilot study is to develop an optimal, clinically usable, non-invasive evaluation of Coronary Artery Disease (CAD) in the setting of stable angina which provides both anatomic and functional information. Patients already scheduled to undergo Invasive coronary catheterization (ICA) for the clinical indication of angina will be recruited to under go stress-rest Positron Emission Tomography-Coronary CT Angiography-Fractional Flow Reserve (PET-cCTA-cFFR)

Detailed Description
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This is a single cohort, technology assessment study. Thirty-five patients presenting with stable angina and a moderate pretest likelihood for CAD who are already scheduled to undergo invasive coronary angiography (ICA) for the clinical indication of angina will be recruited to undergo a cCTA examination with FFR followed immediately by regadenoson stress-rest PET on the same PET/CT scanner. Sensitivity, specificity, NPV, PPV of CTA-cFFR will be obtained using the reference standard of standard of care ICA with FFR for each epicardial coronary artery. Segmental stress PET MBF will be compared to presence or absence of a coronary artery stenosis ≥ 50% diameter on CCTA and ICA.

Official Title
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PET MYOCARDIAL Blood Flow Comparison to Coronary CTA and CT-FFR

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Diagnostic Test: PET-cCTA-cFFR


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-90 years of age, of either sex Patients presenting with stable angina and a moderate pretest likelihood for CAD and scheduled to undergo ICA for the clinical indication of angina. Subjects will undergo this study within 45 days prior to the cardiac catheterization. This study can also be performed 45 days after the cardiac catheterization if the patient had no interventions. Exclusion Criteria: Prior history of stenting, coronary artery bypass graft surgery, or myocardial infarction, unstable angina, atrial fibrillation, second or third degree atrioventricular block, class IV heart failure Iodine allergy Renal dysfunction (creatinine above normal laboratory limits) Symptomatic asthma Women who are pregnant or breast-feeding

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: PET-cCTA-cFFR<br>patients presenting with stable angina and a moderate pretest likelihood for CAD who are already scheduled to undergo ICA for the clinical indication of angina will be recruited to undergo PET-cCTA-cFFR | Diagnostic Test: PET-cCTA-cFFR<br>* patients presenting with stable angina and a moderate pretest likelihood for CAD who are already scheduled to undergo ICA for the clinical indication of angina will be recruited to undergo PET-cCTA-cFFR<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of flow-limiting coronary artery stenosis on CT | CT presence of flow limiting stenosis (≤ 0.8) as determined by CT-FFR in comparison to invasive coronary artery (ICA) FFR. | Day 1 - Day of Scan | 
| Reduction in myocardial myocardial blood flow (MBF) on PET | Decreased MBF (mL/g/min) in regions of coronary stenosis ≥ 50% diameter by CCTA. | Day 1 - Day of Scan |