Remote Ischemic Preconditioning in Patients Undergoing Isolated Aortic Valve Replacement Surgery With a Biological Prosthesis: A Single Center Randomized Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Neuropsychological assesment
研究概览
简要总结
The goal is to investigate the efficacy, safety and possible neuro- and cardioprotective effects of remote ischemic preconditioning (RIPC) in adult cardiac patients undergoing isolated aortic valve replacement surgery with a biological prosthesis. Neuropsychological evaluation preoperatively and at 30d after surgery will establish if there are any differences in neuropsychological performance between groups. A large array of biochemical markers will be analyzed from plasma samples taken at different time points. Additionally skin biopsies from the lower limb will be taken before and after performing RIPC on said limb. During the venous cannulation phase a atrial biopsy will be taken. The biochemical markers from plasma and tissue samples will be used to asses brain tissue damage, inflammation and cardiac tissue damage between groups.
This will be a single center prospective randomized study with two groups. A intervention group (RIPC) and a control group. Study size is: 40 patients in total, 20 patients per group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-emergency aortic valve replacement with a biological prosthesis with perfusion and cardiac arrest
排除标准
- •Recent myocardial infarction
- •Carotid stenosis requiring intervention
- •Any other concomitant surgical procedure
- •Increased troponin baseline before surgery
- •Critical ischemia of lower limbs
- •Peripheral arterial disease (ASO, media sclerosis)
- •Morbid obesity (Incompatible cuff-to-thigh diameter)
- •Severe heart insufficiency
- •Moderate to severe venous insufficiency lower limbs
- •Recent acute stroke <90d
- •Difference in cardioplegic protocol
- •Diseased aorta in epiaortic ultrasound
研究组 & 干预措施
Remote ischemic preconditioning
Patient will undergo normal isolated aortic valve replacement surgery with a biological prosthesis and a preoperative lower leg remote ischemic preconditioning(RIPC) phase.
干预措施: Remote ischemic preconditioning (Procedure)
Control group
Patient will undergo normal isolated aortic valve replacement surgery with a biological prosthesis
结局指标
主要结局
Neuropsychological assesment
时间窗: 1 month postoperatively
Investigators will use a neuropsychological test battery to test our subject pre- and post-operatively. A qualified psychologist will administer the test battery. The test battery will be relatively simple but still have several different tests. These tests will include but are not limited to: - Trail Making test A \& B (TMT)
次要结局
- Tissue specific markers analysed from plasma(A day before surgery, during surgery, 24hour and 48hour postoperatively)
- Inflammation markers analysed from plasma and tissue samples(A day before surgery, during surgery, 24hour and 48hour postoperatively)
研究者
Fredrik Yannopoulos
Resident
Oulu University Hospital