The Effect of Remote Ischemic Preconditioning in Aortic Valve Replacement Surgery : a Randomized Controlled Trial
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
- 1
- 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
研究组 & 干预措施
Control group
Sham remote ischemic preconditioning on the right arm is induced with a blood pressure cuff inflation at 20 mm Hg for 5 min and followed by a 5 min reperfusion at 0 mm Hg. The sham ischemia-reperfusion cycle is performed 3 times for a total of 30 min. This procedure is done after anesthetic induction, but before the patient is placed on cardiopulmonary bypass.
A 20 mm Hg blood pressure cuff on the right arm does not induce ischemia.
干预措施: Blood pressure cuff inflation (Procedure)
Intervention group
Remote ischemic preconditioning on the right arm is induced with a blood pressure cuff inflation at 200 mm Hg for 5 min and followed by a 5 min reperfusion at 0 mm Hg. The ischemia-reperfusion cycle is performed 3 times for a total of 30 min. This procedure is done after anesthetic induction, but before the patient is placed on cardiopulmonary bypass.
干预措施: Blood pressure cuff inflation (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