Clinical trial NCT05349084: PET MYOCARDIAL Blood Flow Comparison to Coronary CTA and CT-FFR
Official title: PET MYOCARDIAL Blood Flow Comparison to Coronary CTA and CT-FFR
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2022-04-27
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Flow-limiting Coronary Artery Stenosis on CT
timeFrame: Day 1 - Day of Scan
measure: Association Between Stress Myocardial Blood Flow (MBF) on PET and Coronary Artery Stenosis on CCTA
timeFrame: Day 1 - Day of Scan
Secondary outcomes:
measure: Correlation of Myocardial Blood Flow (MBF) by PET to Fractional Flow Reserve (FFR) by CT.
timeFrame: Day 1 - Day of Scan
measure: CT-Fractional Flow Reserve (CT-FFR) Global
timeFrame: Day 1 - Day of Scan
measure: Instant Wave Free Ratio (iFR)
timeFrame: Day of invasive coronary catheterization - within 2 weeks of imaging
measure: N-13 Ammonia PET Global Myocardial Blood Flow (MBF) Stress
timeFrame: Day 1 - Day of Scan
measure: N-13 Ammonia PET Global Myocardial Blood Flow (MBF) Rest
timeFrame: Day 1 - Day of Scan
measure: N-13 Ammonia PET Global Myocardial Flow Reserve (MFR)
timeFrame: Day 1 - Day of Scan
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
Study officials:
References: