Cardiac Remote Ischemic Preconditioning Prior to Elective Major Vascular Surgery
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 201
- 试验地点
- 2
- 主要终点
- Troponin I Elevation Above the Upper Reference Limit (URL)
研究概览
简要总结
The investigators have previously shown that elective vascular surgery is a high-risk operation with an anticipated risk of either death or heart attack of 15%. This study is testing whether a protocol of remote ischemic preconditioning (RIPC) applied 24 hours prior to the operation is safe, feasible and reduces the incidence of an adverse, perioperative cardiac complication.
详细描述
The proposed investigation has a single blind, randomized design and plans to enroll 180-205 patients who are scheduled to have major, elective vascular surgery for occlusive carotid disease, expanding abdominal aortic aneurysm (AAA), occlusive lower extremity disease and/or critical limb ischemia at the Minneapolis VA Health Care Center. 24 hours prior to the patient's scheduled vascular operation, RIPC therapy will be applied to one of the participant's upper arms to cause forearm ischemia. Clinically collected, pre-operative troponins, creatine kinase MBs (CK-MBs), EKGs along with troponins, CK-MBs and EKGs collected on day 1, 2, 3 and day 7 (if still hospitalized) will be utilized to evaluate the occurrence of perioperative, adverse cardiac events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergoing elective major vascular surgery at the Minneapolis VA Medical Center for abdominal aortic aneurysm, carotid disease or limb ischemia.
- •Provides informed consent.
排除标准
- •Hypertensive crisis
- •Peripheral arterial disease of the upper extremities
- •Arteriovenous (AV) fistula
- •Acute Coronary Syndrome (ACS) in the last 6 months
- •Severe valvular heart disease
- •Pregnant women
- •Unable to provide consent
结局指标
主要结局
Troponin I Elevation Above the Upper Reference Limit (URL)
时间窗: Within 3 days of the vascular operation
Troponin I is a biomarker of myocardial necrosis that may indicate myocardial damage or injury that occurs during the perioperative period
次要结局
未报告次要终点