Effect of METOprolol in CARDioproteCtioN During an Acute Myocardial InfarCtion. The ME"Effect of METOprolol in CARDioproteCtioN During an Acute Myocardial InfarCtion" (METOCARD-CNIC): A Randomized, Controlled Parallel-group, Observer-blinded Clinical Trial of Early Pre-reperfusion Metoprolol Administration in ST-segment Elevation Myocardial infarctionTOCARD-CNIC Trial.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 221
- 试验地点
- 12
- 主要终点
- Infarct size evaluated primarily by area of delayed enhancement on cardiac magnetic resonance imaging.
研究概览
简要总结
The purpose of this study is to test whether early pre-reperfusion metoprolol administration in patients suffering and acute myocardial infarction might reduce the size of myocardial necrosis.
详细描述
Acute myocardial infarction (AMI) is a chief cause of death worldwide. The best strategy to limit myocardial damage is to perform an early coronary reperfusion. However, despite reperfusion, the size of infarctions is many times large. Infarct size has been recently shown to be a strong predictor of future cardiovascular events and mortality. Therefore interventions aimed at reducing infarct size are the matter of intense research; but despite great efforts, no therapy has been shown to consistently limit infarct size.
ß-blockers are a class of drugs that have been used to treat cardiovascular conditions for several decades. β-blockers reduce mortality when administered after an AMI, and are a class IA indication in this context. What remains unclear is what timing and route of β-blocker administration gives the maximum cardioprotective effect. In particular, whether early β-blocker administration is able to reduce infarct size is a subject of debate. Recent experimental data suggest that the β1 selective blocker metoprolol is able to limit the area of necrosis only when administered before reperfusion.
The objective of this trial is to determine whether the administration of intravenous pre-reperfusion metoprolol might reduce infarct size.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed* acute anterior wall myocardial infarction (ST segment elevation ≥ 2mm in ≥ 2 contiguous leads [one of which should be V2, V3, or V4]).
- •Killip class I or II on diagnosis.
- •Cases of non-confirmed infarction by enzymatic release (above 2 standard deviations from upper limit of CK and Troponin) are excluded from efficacy analysis but kept in the safety analysis.
排除标准
- •COPD or asthma on active bronchodilator therapy
- •Active treatment with beta blockers
- •Left bundle branch block or pacemaker.
- •Systolic blood pressure <120 mmHg, Heart rate <60 bpm, or AV block (PR˃240 mS or superior) on diagnosis.
研究组 & 干预措施
Early metoprolol initiation strategy
干预措施: Injectable (i.v.) metoprolol tartrate (up to 15 mg). (Drug)
结局指标
主要结局
Infarct size evaluated primarily by area of delayed enhancement on cardiac magnetic resonance imaging.
时间窗: 5-7 days after reperfusion
次要结局
- Infarct size evaluated primarily by the area under the curve of CK, CK-MB and troponin release over the first 72 hours of reperfusion.(over the first 72 hours of reperfusion.)
- Infarct size evaluated by area of delayed enhancement on cardiac magnetic resonance imaging in patients with coronary TIMI flow 0-1 of culprit coronary artery.(5-7 days after reperfusion.)
- Percent salvaged myocardium evaluated by cardiac magnetic resonance imaging.(5-7 days after reperfusion)
- Myocardial perfusion evaluated by magnetic resonance imaging.(5-7 days post-reperfusion.)
- Infarct size evaluated by area of delayed enhancement on cardiac magnetic resonance imaging.(at month 6)
- Recovery of myocardial contraction assessed by magnetic resonance imaging and echocardiography.(at month 6)
- Composite of death, malignant ventricular arrhythmias, reinfarction or admission due to heart failure(hospital discharge, 1, 6 and 12 months post-reperfusion.)
- Major cardiovascular events (death, malignant ventricular arrhythmias, AV block, cardiogenic shock, reinfarction).(within first 24 hr post-reperfusion.)