Cardioprotective Effect of Dexmedetomidine in Patients With ST-segment Elevation Myocardial Infarction: a Double-Blind, Multicenter, Randomized, Placebo-Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 250
- 试验地点
- 9
- 主要终点
- Myocardial infarction size (MIS) evaluated by CMR 5±2 days post-STEMI.
研究概览
简要总结
This is a double-blind, multicenter, randomized, placebo-controlled clinical trial. It is planned to enroll patients admitted with anterior ST-segment elevation myocardial infarction (STEMI) within 6h of symptom onset and undergo primary percutaneous coronary intervention (pPCI). Patients who meet the inclusion criteria and without exclusion criteria were randomized 1:1 into the dexmedetomidine (DEX) group or the placebo (saline) group after signing the informed consent. In the DEX group, intravenous injection of DEX was started immediately after enrollment, covering the entire PCI operation, and the administration was stopped at the end of the pPCI. The administration of saline was the same as those in the DEX group. The primary endpoint was the myocardial infarct size (MIS) as assessed by cardiac magnetic resonance imaging (CMR) at 5±2 days post-STEMI. Based on a superiority design and assuming an 20.0% relative infarct size reduction (from 26.0% to 20.8% with a SD of 13.0%), 250 patients are required to be enrolled, accounting for 20% drop-out (α= 0.05 and power= 80%).
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
- Double (Participant, Outcomes Assessor)
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
- •the enrolled subjects must meet all of the following criteria:
- •Aged 18-75 years old (inclusive);
- •Diagnosed with anterior STEMI within 6h of symptom onset: (1) ischemic chest discomfort; (2) electrocardiogram (ECG) with ST elevation ≥0.2 mV in 2 or more contiguous precordial leads (one of which should be V2, V3, or V4);
- •Sign the informed consent form.
排除标准
- •subjects who meet any one of the following criteria are excluded from the study:
- •Ventricular fibrillation, cardiogenic shock, Killip III-IV grade;
- •Sinus bradycardia (heart rate sustained <60 beats/min), PR interval> 240ms or II-III degree atrioventricular block;
- •Continuous systolic blood pressure <120mmHg;
- •Severe breathing difficulties, aterial blood oxygen saturation <92%;
- •Thrombolytic therapy has been performed before the first medical contact in the hospital;
- •Consciousness disorder or past cerebrovascular disease;
- •Previous history of myocardial infarction or PCI/CABG treatment;
- •Known severe liver and kidney dysfunction;
- •Known allergy to dexmedetomidine;
- •CMR contraindications: such as claustrophobia, pacemaker or ICD implantation;
- •Pregnant or lactating women;
- •Malignant tumor or expected survival time <1 year;
- •Any condition which in the opinion of the investigator would make it unsafe or unsuitable for the patient to participate in this study (eg, poor compliance, inability of the patient to comply with study procedures and/or follow up);
- •Participate in other randomized controlled studies at the same time.
研究组 & 干预措施
Dexmedetomidine (DEX) group
The patient began to inject DEX intravenously as soon as he enrolled. This study started with the maximum maintenance dose allowed by the label (0.7μg/kg/h). With reference to previous studies, we set 3 pump injection gradients within the range of 0.2-0.7μg/kg/h (0.2μg/kg/h, 0.45μg/kg/h, 0.7μg/kg/h), and based on the patient's heart rate , systolic blood pressure and RASS sedation score to adjust.
干预措施: Dexmedetomidine (DEX) (Drug)
Placebo (Saline) group
The patient began intravenous injection of normal saline immediately after enrollment. The administration method and dosage adjustment of normal saline are the same as DEX group.
干预措施: Placebo (Saline) (Drug)
结局指标
主要结局
Myocardial infarction size (MIS) evaluated by CMR 5±2 days post-STEMI.
时间窗: 5±2 days post-STEMI
MIS was measured by CMR delayed gadolinium enhancement（expressed as %LV myocardial mass).
次要结局
- Myocardial salvage index (MSI) evaluated by CMR 5±2 days post-STEMI.(5±2 days post-STEMI)
- Microvascular obstruction (MVO) evaluated by CMR 5±2 days post-STEMI.(5±2 days post-STEMI)
- The peak value for troponin I (cTnI) and creatine kinase-MB (CK-MB).(First medical contact in hospital (before drug administration, baseline), and return to ward immediately, 6 Hours, 12 Hours, 24 Hours, 48 Hours after PCI procedure)
- Incidence of major adverse cardiovascular events (MACE): cardiac death, recurrent myocardial infarction, revascularization, rehospitalization due to heart failure.(30 days and 12 months post-STEMI)
- Left ventricular ejection fraction (LVEF) evaluated by CMR 5±2 days post-STEMI.(5±2 days post-STEMI)
- The area under curve (AUC) for troponin I (cTnI) and creatine kinase-MB (CK-MB).(First medical contact in hospital (before drug administration, baseline), and return to ward immediately, 6 Hours, 12 Hours, 24 Hours, 48 Hours after PCI procedure)
- LVEF evaluated by echocardiograhy at 30 days post-STEMI.(30 days post-STEMI)
研究者
Yu Bo
Director
Harbin Medical University