Beneficial Effect of Intracoronary Adenosine on Microvascular and Myocardial Salvage in Patients With Acute Myocardial Infarction (SALVAGE)
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Beneficial Effect of Intracoronary Adenosine on Microvascular and Myocardial Salvage in Patients With Acute Myocardial Infarction
研究概览
简要总结
Investigate the effect of selective intracoronary administration of adenosine on myocardial salvage and microvascular integrity in the setting of acute myocardial infarction.
详细描述
Prospective, single center, randomized clinical study. Study design is random patient assignment to selective intracoronary administration of adenosine or control immediately before restoration of coronary artery patency in patients presenting with an acute ST segment-elevation myocardial infarction (STEMI). Randomisation will be stratified for the duration of symptoms (< 4 hours vs > 4 hours).
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
- Double
入排标准
- 年龄范围
- 0 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Myocardial infarction of less than 12 hours duration with symptoms lasting at least 20 minutes.
- •ECG-criteria: ST-segment elevation of > 0.1 mV in 2 or more limb leads or > 0.2 mV in 2 or more contiguous precordial leads or presumed new left bundle branch block.
- •Written informed consent prior to inclusion in the study. If this is not possible, verbal informed consent from the patient or written assent of a legally acceptable representative should be obtained, to be followed by written informed consent by the patient at the earliest subsequent opportunity.
- •Adequate vascular access seems possible (femoral pulsation palpable).
排除标准
- •Contra-indication to heparin, LMWH, clopidogrel.
- •Anticipated difficulty with vascular access.
- •Cardiogenic shock.
- •Inability to give informed consent (or assent).
- •High grade atrioventricular block; severe asthma; treatment with theophylline, glibenclamide (Diamicron) or dipyridamole.
- •Prior CABG.
- •Participation in an investigational drug or device study within the past 30 days.
结局指标
主要结局
Beneficial Effect of Intracoronary Adenosine on Microvascular and Myocardial Salvage in Patients With Acute Myocardial Infarction
By means of:
1. MR imaging
- at day 2-3: Rest perfusion, MVO, late enhancement and function
- at 4 months: Rest perfusion, late enhancement and function
2. Tissue Doppler Imaging
At 16-36 hours: Resolution of edema/wall thickness increase Function
At 4 months
3 Quantitative Coronary Angiography
TIMI flow grade, TIMI frame count on angiography of the IRA and myocardial blush grade before and at completion of the primary PCI procedure will be performed.
4 Electrocardiographic Analysis
- ST segment resolution will be assessed from the 12-lead ECG on admission and the ECG on admission on C.C.U. after the PCI-procedure. This will be examined for summed ST deviation and for ST deviation in the single lead with maximal ST-deviation on
Finally, the last ECG before hospital discharge and an ECG at 4 months will be studied for the evolution of Q-waves and T-waves.
- 24 hour continuous ST-segment recording in the single lead with maximal ST-deviation on admission with calculation of the area under the curve.
5 Echocardiographic evaluation of left ventricular function
At 16-36 hours
After 4 months
6 Cardiac markers
Blood samples for determination of the MB fraction of creatinekinase and of troponin I are to be taken:
On admission
Before and after PCI, through the sheath
At 90 minutes after PCI
At 8 hours after PCI
At 16 hours after PCI
At 24 hours after PCI
7 Clinical follow-up
Occurrence of MACE (death, new Q-wave or non Q-wave MI or target vessel revascularisation) and the presence of clinical signs of heart failure will be recorded
At hospital discharge
At 30 days
At 6 months
次要结局
未报告次要终点