PET MYOCARDIAL Blood Flow Comparison to Coronary CTA and CT-FFR
- Conditions
- Coronary Artery Disease
- Interventions
- Diagnostic Test: PET-cCTA-cFFR
- Registration Number
- NCT05349084
- Lead Sponsor
- Washington University School of Medicine
- 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)
- 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.
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 21
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description PET-cCTA-cFFR 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
- Primary Outcome Measures
Name Time Method Number of Flow-limiting Coronary Artery Stenosis on CT 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. CT-FFR was determined in the following myocardial segments: left anterior descending (LAD), left circumflex (LCx), and right coronary artery (RCA). The number of coronary artery stenoses as determined by CT (CT-FFR ≤ 0.8) was measured.
Association Between Stress Myocardial Blood Flow (MBF) on PET and Coronary Artery Stenosis on CCTA Day 1 - Day of Scan Association between N-13 Ammonia PET MBF (mL/g/min) during stress and presence or absence of coronary artery stenosis ≥ 50% diameter on CCTA as determined by measurement in each epicardial coronary artery. The MBF values during stress were categorized as normal or abnormal. Normal MBF is defined as \>1.8 mL/g/min. MBF and percent diameter stenosis were determined in the following myocardial segments: left anterior descending (LAD), left circumflex (LCx), and right coronary artery (RCA).
- Secondary Outcome Measures
Name Time Method Correlation of Myocardial Blood Flow (MBF) by PET to Fractional Flow Reserve (FFR) by CT. Day 1 - Day of Scan Correlation of CT-FFR and N-13 Ammonia PET MBF (mL/g/min) during stress as determined by measurement in each epicardial coronary artery. Values were determined in the following myocardial segments: left anterior descending (LAD), left circumflex (LCx), and right coronary artery (RCA).
CT-Fractional Flow Reserve (CT-FFR) Global Day 1 - Day of Scan CT-FFR was calculated using a computational flow/AI FFR program (Siemens). Normal CT-FFR was defined as \>0.80.
Instant Wave Free Ratio (iFR) Day of invasive coronary catheterization - within 2 weeks of imaging The instant wave Free Ratio (iFR) was measured during the patient's clinically scheduled invasive coronary catheterization. Normal iFR was defined as ≥ 0.90.
N-13 Ammonia PET Global Myocardial Blood Flow (MBF) Stress Day 1 - Day of Scan Myocardial Blood Flow was measured by N-13 Ammonia positron emission tomography (PET) during stress following injection of regadenoson.
N-13 Ammonia PET Global Myocardial Blood Flow (MBF) Rest Day 1 - Day of Scan Myocardial Blood Flow (MBF) was measured by N-13 Ammonia positron emission tomography (PET) at rest.
N-13 Ammonia PET Global Myocardial Flow Reserve (MFR) Day 1 - Day of Scan Myocardial flow reserve (MFR) is a ratio between myocardial blood flow (MBF) during stress and at rest, as determined by positron emission tomography (PET). Normal MFR was defined as \> 2.0.
Trial Locations
- Locations (1)
Washington University
🇺🇸Saint Louis, Missouri, United States