To Establish a Multimodal Dynamic Risk Assessment System of Heart Failure in Patients With Myocardial Infarction Based on Coronary Microcirculation.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 567
- 试验地点
- 1
- 主要终点
- Composite endpoint of death or re-admission due to heart failure or aggravation of heart failure symptoms.
研究概览
简要总结
This study aims to explore the heart failure risk model based on the dynamic data of patients with different outcome nodes after myocardial infarction to correct the heart failure risk of patients timely.
详细描述
Heart failure (HF) is the most common complication of acute myocardial infarction (AMI), which seriously affects the prognosis and quality of life of patients. After successful revascularization, the risk of heart failure in patients with acute myocardial infarction is closely related to the state of coronary microcirculation, and the risk of heart failure also changes dynamically with the prognosis of patients. However, current heart failure prediction models only include routine baseline variables to assess short-and long-term risk and lack newly explored new risk factors for heart failure-coronary microcirculation function, there are static, single defects. Therefore, this study is intended to be based on patients with acute ST-segment elevation myocardial infarction who had an infarct artery in the anterior descending artery and underwent emergency percutaneous coronary intervention to open the culprit lesion within 12 hours, according to the multi-dimensional data of clinical epidemiology, serology, radiology, and microcirculation resistance index based on coronary angiography during hospitalization and 6 and 12 months after discharge, respectively, to construct a multimodal dynamic predictive model for heart failure risk at 0-24 months, 6-24 months, and 12-24 months after acute myocardial infarction, to explore the heart failure risk model based on the dynamic data of different outcome nodes of patients after myocardial infarction, and to achieve the goal of timely correction of heart failure risk of patients, which is multi-linear, dynamic and practical, to provide a stage-by-stage reference for follow-up.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-75 years old (including threshold), gender unlimited
- •acute ST-segment elevation myocardial infarction was diagnosed, and the following two criteria were met: A) ischemic chest pain lasting ≥30 min；B) ECG indicating ST-segment elevation ≥0.1 mV in two or more limb leads and/or ≥0.2 mV in two or more adjacent chest leads
- •Coronary angiography confirmed that the culprit's vessel was located in the anterior descending branch, and the proximal and middle segments of the anterior descending branch were occluded (TIMI blood flow 0 or 1), Or TIMI blood flow grade 2 with obvious thrombus (TIMI thrombus score ≥ 2 points, which is determined after the guide wire passes and restores the forward blood flow. The TIMI thrombus score is determined as follows: 0 point: no thrombus is determined；1 point: blurred thrombus image is visible；2 point: clear thrombus image, but the length of the thrombus image is less than 1/2 vessel diameter；3 point: clear thrombus image, the length of the thrombus image is 1/2~2 times the vessel diameter；4 point: clear thrombus image, the thrombus image is more than 2 times the vessel diameter；5 points : complete occlusion of blood vessels)
- •4：Emergency PCI revascularization was completed within 12 hours after the occurrence of myocardial infarction. Postoperative angiography confirmed that residual stenosis was less than 50%.
- •5: Sign the informed consent form voluntarily
排除标准
- •Severe heart failure at discharge (NYHA III/IV, EF<30%)；Or patients with severe hemodynamic instability and cardiogenic shock, defined as systolic blood pressure<90 mmHg, and/or cardiac index<2.2 L/min/m2 during continuous (>30 minutes) attacks, identified as secondary cardiac insufficiency, and/or requiring extraintestinal muscle strength or vasoconstrictor or mechanical support to maintain blood pressure and cardiac index above these specified levels.
- •patients undergoing coronary artery bypass grafting
- •Patients with mechanical complications after myocardial infarction
- •prolonged or invasive cardiopulmonary resuscitation
- •Patients with acute pericarditis, infective endocarditis, severe valvular heart disease and cardiomyopathy
- •Serious liver and kidney failure and other diseases, mental disorders or cognitive disorders
- •The expected survival of tumor patients is less than 2 years
- •patients who are participating in other interventional clinical trials
- •Those who refuse to participate or are clearly unable to complete the follow-up according to the established time point.
结局指标
主要结局
Composite endpoint of death or re-admission due to heart failure or aggravation of heart failure symptoms.
时间窗: Within 24 months after discharge
Readmission due to heart failure was defined as admission with a primary diagnosis of heart failure presenting as a new or worsening heart failure symptom or sign accompanied by elevated natriuretic peptide levels or objective evidence of imaging suggestive of pulmonary systemic congestion; He was treated for heart failure during his hospital stay. Heart failure symptoms aggravate refers to aggravate to New York cardiac function class (NYHA) III/IV
次要结局
- The change of BNP/NT-pro-BNP.(Within 24 months after discharge)
- Changes in 6-minute walking experiment.(Within 24 months after discharge)
- Changes in left ventricular ejection fraction(Within 24 months after discharge)
- Changes in patients' subjective quality of life score(Within 24 months after discharge)
研究者
Jian Liu
Medical Doctor, Chief physician, Professor of Medicine of PUHSC, Doctorial supervisor of PUHSC
Peking University People's Hospital