The CARE-TAVI Study: Cardioprotective Effect of Remote Ischemic Preconditioning in Patients Undergoing Transcatheter Aortic Valve Implantation
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 3
- 主要终点
- post-procedural myocardial injury, defined by the geometric mean (95% CI) of the area under the curve (AUC) for cTnT
研究概览
简要总结
We aim to investigate whether RIPC (remote ischemic preconditioning) is effective in the TAVI setting to reduce post-procedural myocardial damage and improve patient outcome. Accordingly, we aim to investigate whether RIPC can be introduced as an integral part of the TAVI procedure, in order to reduce post-procedural myocardial damage and potentially improve patient outcome.
详细描述
Transcatheter aortic valve implantation (TAVI) is associated to myocardial injury, defined as post-procedural cardiac troponin (cTn) elevation. Earlier experiences have shown that myocardial damage can be encountered in a percentage of patients that varies from 1.5% to 17%, depending on the access route (transfemoral and transapical, respectively). The degree of rise in cTn after TAVI emerged as an independent predictor of mortality.
Remote ischaemic preconditioning (RIPC) consists of brief episodes of ischaemia applied to remote organs or tissues and has shown to result in a significant reduction in postoperative troponin levels in cardiac and non-cardiac surgery patients. Lately, growing evidence suggests that post-procedural troponin decreases due to RIPC application protocols protocols and is associated with improved outcome.
The patients will be divided into two Groups. In Group 1, RIPS will be induced with three cycles of Inflation of a blood-pressure cuff on the left arm to 200 mmHg for 5 min., followed by 5 min. of reperfusion while the cuff is deflated. In controls (Group 2), the cuff will be placed around the left arm without being inflated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Indication for elective TAVI following Heart Team discussion
- •Stable hemodynamic conditions without circulatory support or catecholamines
排除标准
- •Myocardial infarction at least 3 months before enrollment
- •Stroke/TIA at least 3 months before enrollment
- •Severe chronic kidney disease (defined as a baseline serum creatinine of > 1.5 mg/dl or an estimated glomerular filtration rate (eGFR) of 60 ml/min/1.73 m2 )
- •PCI at least 3 months before enrollment
- •Abnormal (>99th percentile of laboratory cut-off) baseline values of biomarkers of myocardial ischemia (i.e. TnT, CK-MB)
- •Abnormal NSE values at baseline (local laboratory cut-off values)
研究组 & 干预措施
with RIPC
RIPC will be induced with three cycles of inflation of a blood-pressure cuff on the left arm to 200 mm Hg for 5 min, followed by 5 min of reperfusion while cuff deflated
干预措施: RIPC (Procedure)
without RIPC
the cuff will be placed around the left arm without being inflated
干预措施: without RIPC (Other)
结局指标
主要结局
post-procedural myocardial injury, defined by the geometric mean (95% CI) of the area under the curve (AUC) for cTnT
时间窗: 72 hours after intervention
Change in cardiac troponine T (cTnT)
次要结局
- Post-procedural myocardial injury(72 hours after intervention)
- Post-procedural acute kidney injury(72 hours after intervention)
- Post-procedural brain injury(72 hours after intervention)
- composite of major adverse cardiac and cerebrovascular events(discharge, at 30 days and at 1 year)