NCT01403337已完成1 期
Cardiac Remote Ischemic Preconditioning Before Elective Major Vascular Surgery (CRIPES)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 205
- 试验地点
- 2
- 主要终点
- Troponin I elevation above the URL
研究概览
简要总结
Vascular surgery is considered a high-risk operation with an anticipated risk of major cardiovascular complications in excess of 5%. The occurrence of a cardiovascular complication after surgery carries a long-term higher mortality risk. The main objective of this investigation is to reduce the proportion of patients having major cardiovascular complications during surgery through a clinical protocol of remote preconditioning that is safe, effective and reproducible.
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)
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
- •Eligible patients would be those undergoing elective major vascular surgery at the Minneapolis VA Medical Center for an expanding abdominal aortic aneurysm, obstructive carotid disease, and/or chronic limb ischemia during the study period. All patients must be ≥ 18 years of age and provide written informed consent.
排除标准
- •Exclusion criteria include hypertensive crisis, acute coronary syndrome in the preceding 6 weeks, severe valvular heart disease, peripheral arterial disease of the upper extremities, manifested by a systolic blood pressure difference greater than 20 mmHg, pregnant women, patients unable to understand the consent process due to mental illness, advanced malignancy with limited life expectancy (<1 year), and hemodialysis with a fistula in the upper extremity.
结局指标
主要结局
Troponin I elevation above the URL
时间窗: Within 1 week after surgery
次要结局
未报告次要终点
研究者
Santiago Garcia
Staff Cardiologist
Minneapolis Veterans Affairs Medical Center
研究点 (2)
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