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

Washington University School of Medicine21 enrolled

Overview

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)

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Coronary Artery Disease

Interventions

PET-cCTA-cFFRDIAGNOSTIC_TEST

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

Washington University

St Louis, Missouri, United States

Outcomes

Primary Outcomes

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. 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.

Time frame: Day 1 - Day of Scan

Association Between Stress Myocardial Blood Flow (MBF) on PET and Coronary Artery Stenosis on CCTA

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).

Time frame: Day 1 - Day of Scan

Secondary Outcomes

Correlation of Myocardial Blood Flow (MBF) by PET to Fractional Flow Reserve (FFR) by CT.

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).

Time frame: Day 1 - Day of Scan

CT-Fractional Flow Reserve (CT-FFR) Global

CT-FFR was calculated using a computational flow/AI FFR program (Siemens). Normal CT-FFR was defined as \>0.80.

Time frame: Day 1 - Day of Scan

Instant Wave Free Ratio (iFR)

The instant wave Free Ratio (iFR) was measured during the patient's clinically scheduled invasive coronary catheterization. Normal iFR was defined as ≥ 0.90.

Data from ClinicalTrials.gov

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