Prevention of Reperfusion Damage and Late Left Ventricular Remodelling With Atorvastatin Administered Before Reperfusion Therapy. The REPERATOR Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- Left ventricular end systolic volume index as measured by cine magnetic resonance imaging (MRI) at 3 month follow-up
研究概览
简要总结
The purpose of this study is to determine if oral atorvastatin administered just before percutaneous coronary angioplasty for acute myocardial infarction improves early and late heart function as compared to placebo.
详细描述
Left ventricular remodelling after a myocardial infarction refers to changes in shape and function of the infarcted and uninfarcted myocardium. Remodelling begins minutes after acute myocardial infarction and may continue for months or years, leading to dilation of the left ventricle (LV) and an increased LV volume. As studies show, LV volume strongly correlates with long-term mortality. Reperfusion after a period of ischaemia (through medication or PTCA) leads to so-called 'reperfusion injury'. This results in myocardial dysfunction and damage, which can lead to LV remodelling.
In a study where atorvastatin was administered at the onset of reperfusion infarct size was reduced. Atorvastatin led to protection of the reperfused myocardium, independently of its effects on cholesterol.
The objective is to measure the effect of atorvastatin, administered orally before reperfusion therapy by PTCA, on infarct size and microvascular reperfusion.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consecutive patients (aged > 18 years) who are to undergo a primary PCI for a first acute ST elevation myocardial infarction will be asked to participate in this study.
排除标准
- •Previous myocardial infarction
- •Previous coronary artery bypass grafting (CABG)
- •Cardiac rhythm is other than normal sinus rhythm.
- •Electrical instability.
- •The patient is in Killip class 3 or 4 of heart failure.
- •Need for intra aortic balloon counterpulsation therapy
- •The patient is unable to hold his/her breath for up to 20 seconds due to age or concomitant illness.
- •Implanted electronic devices are present: pacemakers, internal defibrillators, ECG-registration devices, neurostimulators, implanted drug infusion devices, cochlear implants etc.
- •Previous vascular surgery: aneurysm clip, carotid artery vascular clamp, aortic clips, or venous umbrella
- •Prosthesis (orbital/penile, etc.)
- •Spinal/intra-ventricular shunts.
- •Swan-Ganz catheter; transdermal delivery systems.
- •Metal fragments: eye, head, ear, skin.
- •Implants held by magnets.
- •Known allergy to MR contrast media
- •Prior use of statins
- •No PCI performed
- •No recanalisation achieved
结局指标
主要结局
Left ventricular end systolic volume index as measured by cine magnetic resonance imaging (MRI) at 3 month follow-up
次要结局
- Other MRI measurements of global and regional left ventricular function
- MRI measurements of infarct size at admission, 1 week, and 3 months, as well as changes in these measures between MRI investigations
- Biochemical markers of infarct size
- Blush grade