The Effect of Targeted Stellate Ganglion Morphine Infiltration on Reperfusion Injury in STEMI Patients After Primary PCI: A Multi-Center Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,588
- 试验地点
- 2
- 主要终点
- The incidence of major adverse cardiovascular and cerebrovascular events (MACCE)
研究概览
简要总结
The goal of this clinical trial is to investigate whether morphine modulates the functions of the stellate ganglion to reduce myocardial ischemia/reperfusion (I/R) injury in AMI patients. It will also assess the safety of injecting morphine around the stellate ganglion via ultrasound guidance. The main questions it aims to answer are:
- Does morphine regulate stellate ganglion function to reduce myocardial I/R injury in AMI patients and improve one year outcome in AMI patients? 3. What medical problems do participants experience when receiving injected morphine around the stellate ganglion? Researchers will compare morphine to a placebo saline (as a control group) to determine whether stellate ganglion infiltration with morphine effectively treats patients with AMI following primary PCI.
Participants will:
- Receive a single injection of morphine or saline around the stellate ganglion.
- Evaluate the myocardial injury during their duration of hospital stay.
- Record their symptoms and any major adverse cardiovascular and cerebrovascular events within one year post-surgery.
详细描述
Acute ST-segment elevation myocardial infarction (STEMI) patients (aged ≥18 years) planned for percutaneous coronary intervention (PCI) will be eligible for this study. Patients with severe complications of myocardial infarction, such as uncontrollable acute left heart failure or pulmonary edema, severe cardiogenic shock after cardiopulmonary resuscitation, severe mechanical complications including ventricular septal defect, papillary muscle rupture, and rupture of the left ventricular free wall; with old myocardial infarction, or cardiomyopathy, or malignant arrhythmias controlled by antiarrhythmic drugs; with coagulation disorders due to systemic diseases and those who are currently using anticoagulants and are not suitable for injection; with allergy to opioids or with a history of opioid addiction and those participating in other clinical studies; with pregnant or breastfeeding women; with severe organ dysfunction or failure, such as liver failure, renal failure, and respiratory failure; with severe infections; with severe mental illness that cannot cooperate and those taking antipsychotic drugs or considered unsuitable for this study by the researchers will be excluded. Subjects will be randomly assigned to one of two groups: the placebo group and the morphine group. Patients in the morphine group will receive a single injection of morphine (10 mg, 10 ml) around the left stellate ganglion under ultrasound guidance before coronary artery recanalization. Moreover, the placebo group will receive a 10 ml 0.9% saline infiltration around the stellate ganglion. The incidence of major adverse cardiovascular and cerebrovascular events (MACCE) will be recorded within one year post-surgery as the primary outcome. The secondary outcomes include plasma hs-cTnI levels, evaluation of no-reflow phenomenon, major STEMI-related complications within 30 days post-surgery, rehospitalization rate due to cardiovascular adverse events, individual events of MACCE at one year post-surgery or 30 days post-surgery, All-cause mortality, and postoperative hospital stay.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Aged ≥18 years, Male or Female.
- •Acute ST-segment elevation myocardial infarction (STEMI) patients planned for percutaneous coronary intervention (PCI). Acute STEMI is defined as: electrocardiogram shows ST-segment elevation ≥0.2 mV in two or more adjacent leads, or new left bundle branch block (LBBW).
- •Within 24 hours of the onset of infarct-related chest pain.
- •Obtaining informed consent from the patient and their family.
排除标准
- •Patients with severe complications of myocardial infarction, such as uncontrollable acute left heart failure and pulmonary edema, severe cardiogenic shock after cardiopulmonary resuscitation, severe mechanical complications including ventricular septal defect, papillary muscle rupture, and rupture of the left ventricular free wall;
- •Patients with old myocardial infarction, or cardiomyopathy, or malignant arrhythmias controlled by antiarrhythmic drugs;
- •Patients with coagulation disorders due to systemic diseases and those who are currently using anticoagulants and are not suitable for injection;
- •Patients allergic to opioids or with a history of opioid addiction and those participating in other clinical studies;
- •Pregnant or breastfeeding women;
- •Patients with severe organ dysfunction or failure, such as liver failure, renal failure, and respiratory failure;
- •Patients with severe infections;
- •Patients with severe mental illness that cannot cooperate and those taking antipsychotic drugs;
- •Other patients considered unsuitable for this study by the researchers.
研究组 & 干预措施
Morphine group
Patients in the morphine group will receive a single injection of morphine (10 mg, 10 ml) around the left stellate ganglion under ultrasound guidance before coronary artery recanalization.
干预措施: Morphine (Drug)
Saline group
Patients in the placebo group will receive a single injection of 0.9% saline (10 ml) around the left stellate ganglion under ultrasound guidance before coronary artery recanalization.
干预措施: saline placebo (Drug)
结局指标
主要结局
The incidence of major adverse cardiovascular and cerebrovascular events (MACCE)
时间窗: within one year post-surgery
The incidence of major adverse cardiovascular and cerebrovascular events (MACCE), defined as cardiac death, heart failure rehospitalization, recurrent myocardial infarction, coronary revascularization, and stroke, will be recorded within one year post-surgery.
次要结局
- Postoperative plasma hs-cTnI levels(at 24 hours post-surgery)
- Evaluation of no-reflow phenomenon(perioperative)
- Major STEMI-related complications within 30 days post-surgery(within 30 days post-surgery)
- Rehospitalization rate due to cardiovascular adverse events(within one year post-surgery)
- All-cause mortality(within one year post-surgery)
- Individual events of MACCE at one year post-surgery or 30 days post-surgery(within one year post-surgery or 30 days post-surgery)
- Postoperative hospital stay(Perioperative)
研究者
Ye Zhang
Senior doctor
The Second Hospital of Anhui Medical University