Effects of Lower Leg Remote Ischemic Preconditioning in Combination With Electric Muscle Stimulation in Elective Coronary Artery Revascularisation
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- ST deviation
研究概览
简要总结
The purpose of this study is to investigate if remote ischemic preconditioning by combining limb ischaemia with electric muscle stimulation of the ischemic muscle provokes better results in preconditioning the human heart than limb ischaemia alone does.
详细描述
It has been demonstrated that protection from ischemia reperfusion can be achieved by brief periods of ischemia applied at a remote site during an injurious ischemic event (remote postconditioning). The purpose of this study is to investigate if the combination of brief periods of limb ischemia in combination with electric muscle stimulation at the same site could exceed the preconditioning effect of limb ischemia alone.
Therefore the investigators thought to perform 2 different forms of remote ischaemic preconditioning in patients undergoing elective coronary angioplasty.
In the first patient group a blood pressure cuff will be applied at the lower leg. Ischemia will be induced by inflating the cuff to a pressure of 200 mmHg for 5 minutes. Afterwards reperfusion will be allowed for further 5 minutes. This cycle will be repeated 3 times.
In a second patient group electric muscle stimulation at the same site (HiToP 191) will be performed additionally throughout the whole preconditioning cycle.
After preconditioning, the percutaneous coronary intervention (PCI) will be performed by 3 PCI-ballon inflations, each lasting for 2 minutes. Between the inflations coronary reperfusion will be allowed for 5 minutes.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •planned PCI of one of the main coronary artery (artery diameter distal of the stenotic area at least 2,5 mm)
- •patient age 18 years or older
- •stable angina pectoris symptoms
排除标准
- •presence of collateral vessels
- •electrocardiographic bundle branch blocks
- •multiple coronary stenosis
- •occlusion of a coronary artery
- •renal insufficiency (GFR (MDRD) < 50 ml/min/1,73 m2)
- •presence of coronary bypass grafts
- •history or presence of myocardial infarction.
- •echocardiographic signs of left ventricular hypertrophy (septal and/or posterior wall diameter greater than 14 mm)
- •some sort of medications (adenosine, morphine and derivates, immunosuppressive agents, oral antibiotics, theophyllin, alpha receptor blockers)
- •peripheral arterial disease
- •exercise tests performed within 24 h before study start.
结局指标
主要结局
ST deviation
时间窗: 120 seconds after angioplasty
Immediately after the preconditioning cycle the PCI ballon will be positioned in the coronary artery lesion and inflated for 2 minutes followed by 5 minutes of reperfusion. This cycle will be repeated for 3 times without any interruption. Intracoronary ECGs and 12 lead surface ecgs will be taken immediately before and at the end of each ballon inflation (two minutes after beginning the intracoronary ballon inflation). after taking the ecgs the ballon will be deflated. The st-deviations will be analysed.
次要结局
- troponin I(24 hours after PCI)
- chest pain (Maximum)(time period 2 minutes)
研究者
Marcus Doerr
MD
University Medicine Greifswald