Effect of One Cycle Remote Ischemic Preconditioning on Myocardial Injury After Percutaneous Coronary Interventions in Patients With Stable Coronary Artery Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- hs-Troponin elevation
研究概览
简要总结
Myocardial injury occurs after percutaneous coronary intervention due to micro emboli, ischemia-reperfusion injury or side branch occlusion. 3 cycles of ischemic preconditioning has been shown to be useful in preventing myocardial injury but it is not suitable to perform it especially in ad hoc interventions. In this study the investigators aim is to show whether one cycle remote ischemic preconditioning will be enough to prevent myocardial injury during percutaneous coronary intervention.
详细描述
About in one third of elective percutaneous coronary interventions (PCI) troponin release occurs showing myocardial necrosis. And it has been shown that myocardial necrosis due to coronary interventions has also adverse effects on long term prognosis.
Beneficial effects of of ischemic preconditioning in elective PCI and in coronary artery bypass surgery has been shown in several studies. In most of the trials 3 cycles of ischemia was performed, but this is time consuming and it's not suitable to apply it, in ad-hoc interventions. The investigators found one study showing that one cycle will also be enough to prevent troponin elevation after elective PCI.
The investigators aim was also to show that one cycle preconditioning performed just before coronary intervention will also be useful in preventing myocardial necrosis due to elective PCI.
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
- •Patients with stable coronary artery disease, in whom percutaneous coronary intervention is planned after coronary angiography
- •Patients with informed consent
排除标准
- •Acute or chronic renal failure (Creatinin clearance <60ml/dk)
- •Acute heart failure
- •Presence of hemodynamic instability
- •Left main interventions
- •Acute Coronary Syndrome
- •Patients in whom cuff inflation is contraindicated in upper extremities (fistula, lymphoedema etc)
- •Patients using nicorandil, glibenclamide or trimetazidine
- •Patients not accepting the study
- •Presence of troponin elevation before intervention
- •Presence or suspicion of pregnancy
研究组 & 干预措施
Study group
Remote ischemic preconditioning arm
Blood pressure cuff will be inflated up to 200 mmHg in the non-dominant arm for 5 minutes before guiding catheter engagement.
干预措施: remote ischemic preconditioning (Other)
Control group
No intervention will be performed. Percutaneous coronary intervention will be performed without ischemic preconditioning.
结局指标
主要结局
hs-Troponin elevation
时间窗: after 16 hours
次要结局
未报告次要终点
研究者
Mustafa Adem YILMAZTEPE
Assistant Professor Of Medicine
Trakya University