A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Effect of Shenfu Injection on Reperfusion Injury in Patients With Acute ST Segment Elevation Myocardial Infarction After Primary Percutaneous Coronary Intervention: A Pilot Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Infarct size
研究概览
简要总结
The purpose of this study is to evaluate whether perioperative use of Shenfu Injection could reduce myocardial injury (enzymatic infarct size and infarct volume according to cardiac magnetic resonance imaging) in patients with STEMI after primary PCI
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
- Triple (Participant, Investigator, 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
- •Age ≥18 and <75 years;
- •First-time acute anterior STEMI;
- •The time from onset of ischemic symptom to the time of initial PCI balloon inflation ≤6 hours;
- •>0.1 mV ST segment elevation in at least two contiguous precordial leads according to electrocardiogram;
- •Scheduled for primary PCI;
- •The presence of left anterior descending branch (LAD) occlusion in proximal or middle segment with pre-PCI TIMI flow 0 or 1 according to baseline coronary angiogram;
- •Written informed consent.
排除标准
- •Hypertrophic cardiomyopathy, aortic valve stenosis and/or regurgitation, pericarditis, or myocarditis;
- •Cardiogenic shock, severe ventricular arrhythmia, serious heart failure (Killip class III and above) or mechanical complications;
- •Patients after cardiopulmonary resuscitation (CPR) (including cardioversion);
- •Patients who have already received thrombolytic therapy;
- •Prior myocardial infarction or coronary artery bypass surgery;
- •Known serious hepatic, renal, blood, respiratory, or neuropsychiatric diseases;
- •Malignant tumor, lymphoma, HIV-positive, or hepatitis;
- •Uncontrolled hypertension (systolic BP >160 mm Hg or a diastolic BP >100 mmHg on at least two consecutive readings);
- •Patients with active bleeding, major surgery or trauma within 3 months and cerebrovascular accident within 6 months;
- •History of anemia (hemoglobin<90g/L) or thrombocytopenia (thrombocyte<90×109/L);
- •Multi-vessel disease with non-culprit vessel intervention;
- •Breastfeeding, pregnant, or potentially fertile women;
- •Patients who have known to be allergic to Shenfu Injection or its components or patients with serious adverse effect;
- •Patients with potential contraindication to CMR;
- •Participation in other clinical trial in recent 3 months;
- •Patients who cannot complete this trial or comply with the protocol.
研究组 & 干预措施
Shenfu Injection
80ml Shenfu Injection + 70ml 5% glucose injection), ivdrip, 30 minutes before PCI and 1-5 days (once a day) after PCI (6 times in total). Drug titration time should be no less than 30 minutes.
干预措施: Shenfu Injection (Drug)
5% Glucose Injection
150 ml 5% glucose injection, ivdrip, 30 minutes before PCI and 1-5 days (once a day) after PCI (6 times in total). Drug titration time should be no less than 30 minutes.
干预措施: 5% Glucose Injection (Drug)
结局指标
主要结局
Infarct size
时间窗: immediately after admission (0 hour), and 6, 12, 18, 24, 48, and 72 hours after PCI, as well as 4±1days after PCI
Infarct size was assessed by measuring the area under the curve (AUC) of creatine kinase isoenzyme (CK-MB) within 72 hours after PCI and by performing cardiac magnetic resonance (CMR) imaging at 4±1days after PCI.
次要结局
- Peak value of CK-MB and cTnI(72 hours after PCI)
- Left ventricular end-diastolic diameter (LVEDD), left ventricular end-systolic diameter (LVESD), and Left ventricular ejection fraction (LVEF)(up to 28 days after PCI)
- ST segment resolution (%) according to ECG(up to 24 hours after PCI)
- AUC of cardiac troponin I (cTnI)(immediately after admission (0 hour), and 6, 12, 18, 24, 48, and 72 hours after PCI)
- Main adverse cardiovascular and cerebrovascular events (MACCE, including death, non-fatal myocardial infarction, target vessel revascularization, stroke, new-onset severe heart failure, re-hospitalization for heart failure)(up to 28 days after PCI)
研究者
Shao-Ping Nie
MD, PhD
Beijing Anzhen Hospital