A Prospective, Multi-center Clinical Trial for Evaluating the Effectiveness and Safety of Online Coronary Angiography-Derived Index of Microcirculatory Resistance in STEMI Patients (Flash IV)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 335
- 试验地点
- 8
- 主要终点
- Major Adverse Cardiovascular Events (MACE )
研究概览
简要总结
Despite the success of restoration of epicardial blood flow by the primary percutaneous coronary intervention (PPCI), approximately a half of patients with ST-segment elevation myocardial infarction (STEMI) have failed myocardial reperfusion, as reflected by microvascular obstruction (MVO) and intramyocardial haemorrhage (IMH). The coronary angiography-derived index of microvascular resistance (caIMR) is a brand new method for assessing coronary microcirculation in ischemia and no obstructive coronary artery disease (INOCA). In this trial, the investigators aim to verify the safety and effectiveness of caIMR in STEMI who underwent primary PCI. The investigators will immediately measure the caIMR of patients who successfully underwent pPCI, and combine the caIMR with the long-term prognosis, to verify the prognostic performance of caIMR.
详细描述
Despite the success of restoration of epicardial blood flow by the primary percutaneous coronary intervention (PPCI), approximately a half of patients with ST-segment elevation myocardial infarction (STEMI) have failed myocardial reperfusion, as reflected by microvascular obstruction (MVO) and intramyocardial haemorrhage (IMH). There are many defects in the current measurement technology, such as non-timely, long measurement time, high price, potential risk of gadolinium contrast agent.
The index of microcirculatory resistance (IMR) is a readily available, wire-based approach for assessing microvascular dysfunction immediately post-stenting for STEMI. The parameter has been used to characterize MVO, was associated with infarct size, and subsequent cardiac death and heart failure. However, the application of IMR in clinical practice remains limited, primarily due to the requirement of a pressure-temperature sensor wire and hyperaemic agents, which add complexity and time.
The development of functional coronary angiography has enabled the estimation of IMR based on angiography alone. The coronary angiography-derived index of microvascular resistance (caIMR) has shown good diagnostic accuracy compared with wire-based invasive IMR. This simple alternative index showed an association with extent of MVO and was of prognostic importance. In this trial, the investigators aim to verify the safety and effectiveness of caIMR in STEMI who underwent primary PCI. The investigators will immediately measure the caIMR of patients who successfully underwent pPCI, and combine the caIMR with the long-term prognosis, to verify the prognostic performance of caIMR.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 18 and 80, regardless of gender;
- •Initially diagnosed as STEMI and underwent primary PCI;
- •Voluntarily participated in this trial and signed the informed consent form.
排除标准
- •Coronary angiography shows that PCI is not suitable;
- •Past history of coronary artery bypass grafting (CABG);
- •Past history of heart failure;
- •Past history of myocardial infarction;
- •Primary or secondary cardiomyopathy or heart valve disease;
- •Patients with renal insufficiency (eGFR<30ml/min (1.73m^2)) or patients undergoing dialysis;
- •Cardiogenic shock
- •Persistent left or right coronary ostium lesion after target vessel PCI;
- •Immediate effect of target vessel PCI is unsatisfactory [such as thrombolysis in myocardial infarction (TIMI) flow < grade 2, dissection that restricted blood flow, side branch occlusion (diameter>1.5mm), exist distal embolism or angiographically visible thrombus];
- •Target vessel exist coronary fistula or myocardial bridge (lumen constriction >50%);
- •The target vessel cannot clearly expose the lesion in two positions with an included angle ≥ 30 degrees;
- •Severe systemic infection
- •Patients with malignant wasting disease, with an estimated survival of less than 1 year;
- •The subject is participating in another clinical researches, and the primary endpoint has not been reached;
- •The investigator believes that the subject has other conditions that are not suitable for clinical trials.
结局指标
主要结局
Major Adverse Cardiovascular Events (MACE )
时间窗: 12 months
Rate of MACE. MACE was defined as a composite endpoint of cardiac death, myocardial reinfarction, readmission for heart failure, and unplanned readmission for ischemia.
次要结局
- Stroke(12 months)
- Malignant arrhythmia(12 months)
- Target vessel failure (TVF)(12 months)
- MACE(1 month; 6months)
- Outcome events for each category(12 months)