Simultaneous Measurements Of Pressure Gradient, Blood Flow and Percentage Area Stenosis Of Coronary Epicardial Lesions To Assess Severity Of Epicardial Stenosis And Myocardial Infarction
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 4
- 主要终点
- to detect ischemic heart disease in patients with abnormal stress tests using MPI with SPECT and to determine the presence of significant epicardial stenosis using coronary angiography with simultaneous physiological pressure and flow measurements
研究概览
简要总结
Newly developed diagnostic parameters have potential to differentiate between epicardial disease and microvascular dysfunction with the help of anatomical details and physiological endpoints and can be used in present clinical settings.
详细描述
The pressure drop coefficient (CDP) is a functional index based on hyperemic dp and u measurements. The lesion flow coefficient (LFC) combines the functional index CDP with an atomic measure (percentage area stenosis) as a single parameter.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Abnormal Myocardial stress perfusion (SPECT) LV EF > 25%
- •18 years of age or above
- •Patients referred to a stress test by a Cardiologist
- •Acute Chest pain, as per patient input.
- •Risk Assessment with prior test results and/or previous history of known chronic stable CAD.
- •Borderline or discordant stress testing where obstructive CAD remains a concern.
- •New or worsening symptoms- Abnormal coronary angiography or abnormal prior stress imaging study.
- •Coronary stenosis or anatomic abnormality of uncertain significance.
- •In absence of reliable diagnostic information from another imaging modality.
排除标准
- •Serum Creatinine > 2.5 gm/dL
- •Type II HIT
- •Left ventricular ejection fraction less the 25% determined by gated SPECT imaging ( - LV < or + to 25%)
- •Non-dialysis dependent chronic kidney disease with baseline serum creatinine greater than 2.5 gm/dL.
- •History of type II heparin-induced thrombocytopenia.
- •Significant co-morbid condition that is medically unstable and would make coronary angiography prohibitive or contraindicated.
- •Pregnant women.
- •Incapacitated for Consent
研究组 & 干预措施
CDP LFC
all patients will have this calculation based upon diagnostic parameters with IVUS and FFR and/or CFR
干预措施: FFR/CFR and IVUS (Device)
结局指标
主要结局
to detect ischemic heart disease in patients with abnormal stress tests using MPI with SPECT and to determine the presence of significant epicardial stenosis using coronary angiography with simultaneous physiological pressure and flow measurements
时间窗: Upon Diagnostic Angiogram and Flow Wire
次要结局
- To compare novel measurements, Pressure Drop Coefficient (CDP) & Lesion Flow Coefficient (LFC), against measured current parameters called Fractional flow reserve (FFR) & Coronary flow reserve (CFR).(Upon Diagnostic Angiogram and Flow Wire)
研究者
Rupak K. Banerjee
Professor
University of Cincinnati