A Safety and Feasibility Study of Transcoronary Myocardial Buffering and Cooling During Primary Coronary Angioplasty to Reduce Myocardial Reperfusion Injury in Acute Myocardial Infarction.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Symptoms of Chest pain and breathlessness using a Visual Analog Scale
研究概览
简要总结
Patients with heart attacks caused by blocked coronary arteries are usually treated with a technique called primary angioplasty. Although this treatment is very successful it can result in damage to the heart muscle when the artery is opened due to reperfusion injury. Cooling the entire body has been shown to reduce heart muscle damage during heart attacks in some patients but not in others, however it is uncomfortable due to the shivering, expensive and can result in delays in opening the blocked artery. We are investigating a simpler way to cool the heart muscle directly using cooled fluid passed through the catheter without the shortcomings of entire body cooling. This pilot will address safety and feasibility considerations.
详细描述
The precise mechanisms involved in ischaemia/reperfusion injury is not fully understood but a number of factors are thought to contribute to cardiac dysfunction14, 15. These include : 1. reperfusion arrhythmias; 2. microvascular obstruction or no-reflow phenomenon; 3. myocardial stunning and 4. cardiomyocyte apoptosis. It is estimated that ischaemia/reperfusion injury occurs in > 30% of patients and is associated with reduced myocardial salvage and poor prognosis16-18. Ischaemia/reperfusion injury may account for up to 50% of the final infarct size9.
Deep hypothermia (< 30 °C) has long been used in protecting the heart during coronary artery bypass grafting and heart transplantation. Intermittent antegrade or retrograde infusion of cold cardioplegia appears to reduce myocardial ischaemia and improves outcome19, 20. Deep hypothermia however can cause spontaneous ventricular fibrillation and impaired cardiac function and its application is limited to the unconscious patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Men and women aged between 18 and 80 years presenting with ischaemic chest pain of <6 hours and STsegment elevation on the ECG of >0.2 mV in 2 contiguous leads.
排除标准
- •Patients with cardiac arrest, previous AMI or CABG, known congestive heart failure, endstage kidney disease or hepatic failure, recent stroke, coagulopathy, pregnancy, or cardiogenic shock.
- •Patients who are unable or unwilling to provide assent and informed consent.
结局指标
主要结局
Symptoms of Chest pain and breathlessness using a Visual Analog Scale
时间窗: Throughout the PPCI Procedure and for One Hour Afterwards
Intracoronary temperature measured with thermistor wire
时间窗: Throughout the PPCI Procedure only
Haemodynamic changes using the blood pressure (mmHg) and heart rate (beats /min)
时间窗: Throughout the PPCI Procedure and for One Hour Afterwards
ECG changes (ST segment shift in mm)
时间窗: Throughout the PPCI Procedure and for One Hour Afterwards
Duration and Volume of perfusate infused used (total time-mins and total volume-mls)
时间窗: Throughout the PPCI Procedure and for One Hour Afterwards
次要结局
- Biomarker rise (Cardiac troponin)(24 hours post PCI procedure)
- Myocardial infarct size measured with MRI Heart Scan(During hospital admission)