A Clinical Trial for CT Myocardial Perfusion Based Non-invasive Index of Microciculatory Resistance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 295
- 试验地点
- 1
- 主要终点
- sensitivity and specificity
研究概览
简要总结
Coronary artery microvascular disease (CMVD) lacks reliable and non-invasive quantitative diagnosis methods. Improving coronary microcirculation has become one of the main goals of coronary heart disease treatment. In this study, by establishing the key influencing factors of myocardial microcirculation perfusion, an accurate three-dimensional reconstruction method of coronary artery was established, and a non-invasive coronary microcirculation resistance index (CT-IMR) calculation method based on computational fluid method mechanics was established. At the same time, a phase I single-center clinical verification and a multi-center clinical verification of the non-invasive coronary microcirculation function precision assessment system were carried out, and a non-invasive coronary microcirculation detection system and technology were established.
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
- 是
入选标准
- •Subject must be older than 18 years
- •Written informed consent available
- •Subject is indicated for invasive coronary angiography
- •Subject need to be taken within 30 days after enrolment
排除标准
- •Previous PCI or CABG
- •Subject is not eligible for measuring IMR
- •Complicated complex congenital heart disease
- •Artificial pacemaker or internal defibrillator leads implanted
- •Implanted artificial heart valve
- •Severe arrhythmia including complete AV block, ventricular arrhythmia
- •Impaired chronic renal function (serum creatinine>1.5ULN)
- •Allergic to iodine
- •Pregnancy
- •Body mass index >35 kg/m2
- •Left ventricle is markedly thickened
- •Needs for emergency procedures
- •Severe distortion of in the blood vessel
- •Unstable haemodynamics including abrupt chest pain cardiogenic shock, unstable blood pressure (systolic < 90mmHg), severe congestive heart failure or pulmonary edema
- •Life-threatening diseases (life expectancy < 2 months)
- •Tako Tsubo syndrome (TTS)
- •Others who are inappropriate subject judged by clinician
研究组 & 干预措施
Study group
All consecutive patients undergoing outine CT angiography and dynamic CT-myocardial perfusion imaging(MPI) will be potentially eligible for inclusion in the trial. Assessment of coronary stenosis severity using invasive fractional flow reserve (FFR) and the status of myocardial microcirculation perfusion including coronary flow reserve (CFR) and index of microvascular resistance (IMR) will be performed as part of invasive coronary angiography(CAG).
干预措施: CCTA, CT-MPI, DSA, FFR (Diagnostic Test)
结局指标
主要结局
sensitivity and specificity
时间窗: up to 12 months
The sensitivity and specificity of CT-IMR in the diagnosis of microcirculation dysfunction were studied.
次要结局
- diagnostic(up to 12 months)
研究者
Jinyu Huang
professor
First People's Hospital of Hangzhou