Derivation and Validation of a Novel Adenosine-independent Index of Coronary Artery Stenosis Severity Resting Flow Reserve
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Percentage Agreement Between Mean RFR and iFR Measurements
研究概览
简要总结
This study will enroll patients who are referred for coronary angiography and require physiological assessment to see if the lesion can be treated as per the local standard of care. Approximately 92 participants will be enrolled. There are no follow up visits required so participation in this study will end when subjects are discharged from the hospital.The study will be comparing the resting flow reserve against the instantaneous wave-free ratio (iFR) and fractional flow reserve. All these tests offer a way to image a legion and determine if it is suitable to be treated. FFR measures the pressure differences across (narrowed coronary arteries usually due to atherosclerosis), iFR's are performed during cardiac catheterisation (angiography) using invasive coronary pressure wires which are placed in the arteries of the heart that are to be assessed and the Resting flow reserve looks at the maximum increase in blood flow through the coronary arteries above the normal resting volume.
详细描述
Fractional flow reserve (FFR) measurement by under hyperemic conditions has become the invasive gold standard for determining the physiologic extent of cardiac ischemia, and which has been validated in several clinical outcomes studies as a way of optimizing case selection for percutaneous coronary intervention (PCI). More recently in two large-scale randomized controlled trials using a non-hyperemic resting measurement, the instantaneous wave free ratio (iFR) showed non-inferiority in major adverse cardiovascular events (MACE) comparing iFR to FFR for physiological assessment of moderate coronary stenosis. FFR is calculated as the ratio of the distal coronary pressure to the aortic pressure (Pd/Pa) during maximal micro-circulatory relaxation. iFR is a diagnostic tool used to assess whether a stenosis is causing a limitation of blood flow in coronary arteries with subsequent ischemia. iFR is performed during cardiac catheterization (angiography) using invasive coronary pressure wires which are placed in the coronary arteries that are to be assessed. The iFR negates the time averaging and administration of vasodilators necessary for FFR by identifying from the resting pressure waveform a period when the native microcirculatory resistance is constant and minimized in diastole. The study is looking at the accuracy and precision of a novel adenosine-independent index of coronary artery stenosis, the resting flow reserve, against the instantaneous wave-free ratio and fractional flow reserve.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years.
- •Patient provides signed written informed consent before any study-specific procedure.
- •Undergoing coronary angiography, for silent ischemia, stable angina, acute coronary syndrome, or other acceptable indication per the local standard of care.
- •Angiographically 40%-90% stenosis present in at least one native coronary artery.
- •Undergoing physiological assessment for standard clinical or diagnostic indications
排除标准
- •Aorto-ostial lesion location within 3 mm of the aorta junction (both right and left).
- •Left main stenosis
- •Vessel(s) and lesion(s) not amenable for percutaneous coronary intervention (PCI) , for example diffuse disease.
- •Saphenous vein graft, chronic total occlusion
- •Haemodynamic instability at the time of intervention (heart rate<50 beats per minute, systolic blood pressure <90mmHg), balloon pump
- •Currently participating in another clinical study that interferes with study results.
- •Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure.
- •Any other medical condition that in the opinion of the investigator will interfere with patient safety or study results.
- •High degree A-V block, sinus node disease.
- •Asthma/Chronic obstructive pulmonary disease (COPD) with active wheeze
- •Known hypersensitivity to adenosine
- •ST-Elevation Myocardial Infarction (STEMI) within 48 hours.
结局指标
主要结局
Percentage Agreement Between Mean RFR and iFR Measurements
时间窗: During procedure
Mean RFR measurements will be compared against mean iFR measurements to determine if there is an agreement between RFR and iFR for detection of ischemia.
次要结局
- Pressure Drift of RFR(During procedure)
- Lesion Classification (FFR≤/>0.80) by RFR(During procedure)
- Lesion Classification (FFR≤/>0.80) by iFR(During procedure)
- Pressure Drift of iFR(During procedure)
- Measurement Reproducibility for RFR(During procedure)
- Ability to Advance to the Target Lesion and Measure RFR and iFR(During procedure)
- Measurement Reproducibility for iFR(During procedure)
研究者
Ajay Kirtane
Associate Professor of Medicine
Columbia University