NCT07186972尚未招募不适用
Evaluation of Mild Therapeutic Hypothermia in Percutaneous Coronary Intervention Under Venous-arterial Extracorporeal Membrane Oxygenation for Acute Myocardial Infarction Complicated With Cardiogenic Shock
Beijing Anzhen Hospital0 个研究点目标入组 44 人开始时间: 2025年9月1日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 44
- 主要终点
- Myocardial Salvage Index (MSI)
研究概览
简要总结
This study is a randomized controlled trial conducted at Beijing Anzhen Hospital, Capital Medical University. The primary objective is to assess the efficacy of mild therapeutic hypothermia in reducing infarct size and improving cardiac function in patients receiving percutaneous coronary intervention under venous-arterial extracorporeal membrane oxygenation for acute myocardial infarction complicated with cardiogenic shock. Secondary objectives include evaluating the safety of mild therapeutic hypothermia and its impact on venous-arterial extracorporeal membrane oxygenation weaning success and short-term survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Patients diagnosed with acute myocardial infarction complicated by cardiogenic shock who undergo emergency percutaneous coronary intervention under venoarterial extracorporeal membrane oxygenation support and endotracheal intubation.
- •Patients diagnosed with anterior wall myocardial infarction.
- •Aged ≥18 years.
排除标准
- •Cardiogenic shock lasting more than 12 hours or a history of chronic congestive heart failure.
- •History of prior coronary artery intervention, coronary artery bypass grafting, heart transplantation, heart-lung transplantation, or left ventricular assist device implantation.
- •Cardiogenic shock associated with mechanical complications of acute myocardial infarction, such as ventricular septal rupture, acute mitral regurgitation, acute ventricular septal defect, and cardiac tamponade.
- •Refractory out-of-hospital cardiac arrest or cardiopulmonary resuscitation lasting longer than 45 minutes.
- •Known end-stage renal disease (e.g., on dialysis or post-kidney transplantation) or severe liver failure (e.g., cirrhosis or acute hepatitis).
- •Contraindications to hypothermia therapy, such as cryoglobulinemia, sickle cell disease, cold agglutinin disease, and vasospastic disorders (e.g., Raynaud's disease and thromboangiitis obliterans).
- •Refusal to undergo 99mTc-sestamibi single photon emission tomography imaging or presence of known or suspected contraindications to 99mTc-sestamibi single photon emission tomography imaging.
- •Currently participation in other interventional clinical trials.
- •Refusal to sign informed consent related to this trial.
结局指标
主要结局
Myocardial Salvage Index (MSI)
时间窗: 3 day (± 1 day) post-percutaneous coronary intervention
Myocardial Salvage Index (MSI) is measured by 99mTc-sestamibi single photon emission tomography at day 3 (± 1 day) post-percutaneous coronary intervention, calculated as MSI = (area at risk-final infarct size)/area at risk, where area at risk is the area at risk and final infarct size is the final infarct size.
次要结局
- Area under the curve of serum creatine kinase-MB within 72 hours post-percutaneous coronary intervention(72 hours post-percutaneous coronary intervention)
- Area under the curve of serum cardiac troponin I within 72 hours post-percutaneous coronary intervention(72 hours post-percutaneous coronary intervention)
- Cardiac function(Baseline, and every 24 hours post-percutaneous coronary intervention up to discharge.)
- Serum N-terminal pro-B-type natriuretic peptide levels(Baseline, and every 4 hours post-percutaneous coronary intervention up to discharge.)
- Arterial blood lactate levels(Baseline, and every 4 hours post-percutaneous coronary intervention up to discharge.)
- Major adverse cardiovascular events(24 hours, 7 days, 30 days post-percutaneous coronary intervention, and during hospitalization)
- Rates of successful extracorporeal membrane oxygenation weaning(Wean off extracorporeal membrane oxygenation after 24 hours)
- Rates of heart transplantation, or implantation of left ventricular assist device through study completion(At discharge)
- Mortality(24 hours, 7 days, and 30 days post-percutaneous coronary intervention, and during hospitalization)
- Extracorporeal membrane oxygenation-related complications(Up to ECMO weaning)
- Mild therapeutic hypothermia-associated safety events(24 hours, 7 days, and 30 days post-PCI, and during hospitalization)
- Mean arterial pressure, and heart rate(Baseline, and every 4 hours post-percutaneous coronary intervention up to discharge.)
- Blood routine examination(Baseline, and every 4 hours post-percutaneous coronary intervention up to discharge.)
- Coagulation function monitoring(Baseline, and every 4 hours post-percutaneous coronary intervention up to discharge.)
研究者
Chenglong Li
Professor
Beijing Anzhen Hospital
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