N/A
N=21
PET MYOCARDIAL Blood Flow Comparison to Coronary CTA and CT-FFR
Coronary Artery Disease
Bottom Line
View on ClinicalTrials.gov: NCT05349084 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: Primary: Number of Flow-limiting Coronary Artery Stenosis on CT — 8 Coronary arteries
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- PET-cCTA-cFFR (Diagnostic_test)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Jul 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Flow-limiting Coronary Artery Stenosis on CT |
8 | — |
| PRIMARY Association Between Stress Myocardial Blood Flow (MBF) on PET and Coronary Artery Stenosis on CCTA |
9; 7; 17; 27 | 0.2522 |
| SECONDARY Correlation of Myocardial Blood Flow (MBF) by PET to Fractional Flow Reserve (FFR) by CT. |
0.284 | 0.028 sig |
| SECONDARY CT-Fractional Flow Reserve (CT-FFR) Global |
0.90; 0.93; 0.73 | — |
| SECONDARY Instant Wave Free Ratio (iFR) |
0.92 | — |
| SECONDARY N-13 Ammonia PET Global Myocardial Blood Flow (MBF) Stress |
1.88 | — |
| SECONDARY N-13 Ammonia PET Global Myocardial Blood Flow (MBF) Rest |
0.94 | — |
| SECONDARY N-13 Ammonia PET Global Myocardial Flow Reserve (MFR) |
2.05; 2.31; 1.67 | — |
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)
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
Data sourced from ClinicalTrials.gov (NCT05349084). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.