NCT03305094进行中（未招募）不适用
The Effect of Remote Ischemic Preconditioning in Aortic Valve Replacement Surgery : a Randomized Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Change in biochemical markers of myocardial ischemia
研究概览
简要总结
The study objective is to verify if a non-invasive remote ischemic preconditioning procedure (blood pressure cuff on the arm) is cardioprotective when applied before an aortic valve replacement surgery.
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 (Participant)
盲法说明
Participant is blinded to group assignment
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 isolated aortic valve replacement (stenosis based)
- •Age ≥ 18 years
排除标准
- •Pregnancy
- •Left ventricular dysfunction (LVEF< 50%)
- •Myocardial Infarct (< 7days)
- •Coronary artery disease (documented with >50% stenosis)
- •Coronary artery bypass grafting
- •Chronic renal insufficiency (creatinine >175 mmol/L or dialysis)
- •Endocarditis
- •Sternotomy redo
- •Deep vein thrombosis to the compressed limb
- •Emergency procedure
- •TAVI procedure
- •Planned off pump coronary artery bypass
- •MAZE procedure
结局指标
主要结局
Change in biochemical markers of myocardial ischemia
时间窗: 6, 12, 24 and 48 hours post-operatively
Troponin T-HS and CK-MB concentration
次要结局
- Post-operative complications(post-operatively until 30 days)
研究者
Pierre Voisine
Cardiac surgeon
Laval University
研究点 (2)
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