PET MYOCARDIAL Blood Flow Comparison to Coronary CTA and CT-FFR
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Number of Flow-limiting Coronary Artery Stenosis on CT
研究概览
简要总结
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)
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Number of Flow-limiting Coronary Artery Stenosis on CT
时间窗: 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
时间窗: 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).
次要结局
- Correlation of Myocardial Blood Flow (MBF) by PET to Fractional Flow Reserve (FFR) by CT.(Day 1 - Day of Scan)
- CT-Fractional Flow Reserve (CT-FFR) Global(Day 1 - Day of Scan)
- Instant Wave Free Ratio (iFR)(Day of invasive coronary catheterization - within 2 weeks of imaging)
- N-13 Ammonia PET Global Myocardial Blood Flow (MBF) Stress(Day 1 - Day of Scan)
- N-13 Ammonia PET Global Myocardial Blood Flow (MBF) Rest(Day 1 - Day of Scan)
- N-13 Ammonia PET Global Myocardial Flow Reserve (MFR)(Day 1 - Day of Scan)