PET MYOCARDIAL Blood Flow Comparison to Coronary CTA and CT-FFR
Study Details
Study Description
Brief Summary
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)
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
We will derive sensitivity, specificity, NPV, PPV of CTA-cFFR compared to the reference standard of standard of care ICA with FFR for each epicardial coronary artery.
We will correlate segmental stress PET MBF to presence or absence of a coronary artery stenosis ≥ 50% diameter on CCTA and ICA.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: PET-cCTA-cFFR 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
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
|
Outcome Measures
Primary Outcome Measures
- CT presence of flow-limiting coronary artery stenosis [Day 1 - Day of Scan]
CT presence of flow limiting stenosis (≤ 0.8) as determined by CT-FFR in comparison to invasive coronary artery (ICA) FFR.
- PET presence of decreased myocardial myocardial blood flow (MBF) [Day 1 - Day of Scan]
Decreased MBF (mL/g/min) in regions of coronary stenosis ≥ 50% diameter by CCTA.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
18-90 years of age, of either sex
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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:
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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
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Iodine allergy
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Renal dysfunction (creatinine above normal laboratory limits)
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Symptomatic asthma
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Women who are pregnant or breast-feeding
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Washington University | Saint Louis | Missouri | United States | 63110 |
Sponsors and Collaborators
- Washington University School of Medicine
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 201904112