Effect of Shenfu Injection on Myocardial Injury in Patients With Acute ST Segment Elevation Myocardial Infarction After Primary Percutaneous Coronary Intervention: A Multicenter, Randomized, Double-Blinded, Parallel-Group, Placebo-Controlled Clinical Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 326
- 试验地点
- 1
- 主要终点
- Infarct size (% of left ventricular mass)
研究概览
简要总结
This study aims to evaluate whether perioperative use of Shenfu Injection, as compared to placebo, could reduce infarct size assessed by cardiac magnetic resonance (CMR) in patients with acute anterior ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI).
详细描述
Shenfu injection is a traditional Chinese medicine formulation containing ginseng (Panax; family: Araliaceae) and aconite (Radix aconiti lateralis preparata, Aconitum carmichaeli Debx; family: Ranunculaceae) with Ginsenosides and aconite alkaloids as the main active ingredients. Its quality is strictly controlled in compliance with the standard of the China Ministry of Public Health (official approval code: certification number Z20043117; No. 110804, Ya'an, China). Animal studies have shown that Shenfu injection has protective effects against reperfusion injury through multiple pharmacologic effects, including scavenging free radicals, inhibiting inflammatory mediators, suppressing cell apoptosis, and inhibiting calcium overload. However, few data are available regarding its efficacy in humans. We aimed to determine whether perioperative use of Shenfu injection, as compared to placebo, might reduce infarct size in patients with STEMI undergoing 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 scheduled for primary PCI.
- •ST segment elevation in at least two contiguous precordial leads according to electrocardiogram (>30 min).
- •Symptoms onset ≤12 hours.
- •The presence of proximal or middle left anterior descending branch (LAD) occlusion with pre-PCI TIMI flow 0 or 1 according to baseline coronary angiogram.
- •Written informed consent.
排除标准
- •Cardiogenic shock, serious heart failure (Killip class III or above), malignant ventricular arrhythmia, or mechanical complications.
- •Post cardiopulmonary resuscitation (CPR) (including cardioversion).
- •Patients who have received thrombolytic therapy or upstream GPIIb/IIIa inhibitors (GPI).
- •Uncontrolled hypertension (systolic BP ≥180 mm Hg or a diastolic BP ≥110 mmHg).
- •Prior myocardial infarction, PCI or coronary artery bypass graft.
- •Known severe hepatic insufficiency (AST/ALT >3-fold the upper limit of normal value) or known renal insufficiency.
- •Malignant tumor, lymphoma, HIV-positive, or cirrhosis with life expectancy <1 year.
- •Patients with active bleeding, intracranial hemorrhage, major surgery or trauma within 1 months, or ischemic stroke or transient ischemic attack (TIA) within 6 months.
- •History of anemia (hemoglobin<90g/L) or thrombocytopenia (thrombocyte<100×109/L).
- •Patients who require simultaneous intervention of left main disease during primary PCI or those with multi-vessel disease who plan to intervene in non-culprit vessels within 7 days (simultaneous or staged).
- •Scheduled for CABG within one month after randomization.
- •Pregnancy, lactation, 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 contraindication to CMR (metal foreign body in the body, claustrophobia, etc.).
- •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
干预措施: Shenfu Injection (Drug)
5% Glucose Injection
干预措施: 5% Glucose Injection (Drug)
结局指标
主要结局
Infarct size (% of left ventricular mass)
时间窗: 5±2 days after PCI
Infarct size was assessed by performing CMR imaging at 5±2 days after PCI
次要结局
- Microvascular obstruction (% of left ventricular mass)(5±2 days after PCI)
- Left ventricular end-diastolic volume (LVEDV)(5±2 days after PCI)
- Left ventricular ejection fraction (LVEF)(5±2 days after PCI)
- AUC of cardiac troponin I(Immediately after admission (0 hour), and 6, 12, 18, 24, 48, and 72 hours after PCI)
- Peak value of CK-MB and cTnI(72 hours after PCI)
- ST segment resolution (%) according to ECG(24 hours after PCI)
- Corrected TIMI frame count (CTFC)(Immediately after PCI)
- TIMI myocardial perfusion grade (TMPG)(Immediately after PCI)
- Area at risk (myocardial edema, % of left ventricular mass)(5±2 days after PCI)
- Individual events (including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, emergency revascularization, re-hospitalization for heart failure)(30 days after PCI)
- Intramyocardial hemorrhage (% of left ventricular mass)(5±2 days after PCI)
- Area under the curve (AUC) of creatine kinase isoenzyme (CK-MB)(Immediately after admission (0 hour), and 6, 12, 18, 24, 48, and 72 hours after PCI)
- TIMI flow grade(Immediately after PCI)
- Myocardial salvage index(5±2 days after PCI)
- Left ventricular end-systolic volume (LVESV)(5±2 days after PCI)
- Major adverse cardiovascular and cerebrovascular events (MACCE, including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, emergency revascularization)(30 days after PCI)
研究者
Shao-Ping Nie
Professor of Medicine, Director, Emergency & Critical Care Center
Beijing Anzhen Hospital