Protection of the Heart With Remote Ischemic Preconditioning During Heart Surgery: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- Myocardial Protection Against Ischemic Injury
研究概览
简要总结
The purpose of this study is to compare a treatment called remote ischemic preconditioning (rIP) to no treatment. rIP is a simple treatment that is believed to help patients recover better after heart surgery. This treatment involves applying a large blood pressure cuff to one leg. The blood pressure cuffs will be inflated for 5 minutes and then deflated for 5 minutes. This will be done 4 times in a row.
详细描述
Purpose:
- Determine, in a pilot study, if surrogate markers of rIP can be detected in patients presenting for cardiac surgery. Specifically measure the effect of rIP on the expression profile of HSP-70, iNOS, PKC-E, p38 MAPK, PI3K, and sarcolemmal KATP
- Determine if rIP influences the expression of genes known to influence substrate preference and thereby myocardial metabolism in patients undergoing heart surgery. Specifically the expression of HIF-1a, PPAR-a and AMPK
Hypothesis:
We hypothesize that rIP provides myocardial protection in patients presenting for heart surgery and that this protection is defined by a distinct gene expression profile with regards to genes involved in rIP and myocardial metabolism.
Study Design:
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •Age 18 through 80 years, inclusive
- •Scheduled for heart surgery with CPB
排除标准
- •Females of childbearing potential
- •Emergency surgery
- •Previous sternotomy
- •Myocardial infarction within 48 hours prior to surgery
- •Diabetes and/or BMI >35
- •Need for Alpha2-agonists perioperatively
- •Peripheral Vascular Disease
研究组 & 干预措施
Ischemic Preconditioned Group (rIP)
A 15-cm sterile blood pressure cuff was placed around the right thigh and connected to the inflating device, and the patient was draped obscuring the visibility of the cuff. Subsequently, the patient was randomly allocated (by opening of an envelope) to RIPC consisting of four 5-min cycles of lower limb ischemia-reperfusion induced by a tourniquet inflated to 300 mmHg
干预措施: Blood Pressure Cuff (Device)
No Cuff
No rIP
结局指标
主要结局
Myocardial Protection Against Ischemic Injury
时间窗: 72 hours post operatively
High-sensitivity cardiac troponin T release as measured by peak hscTnT values and area-under-the-curve.
次要结局
- All-cause Death and Cardiovascular Long-term Outcome(6-month cardiovascular outcome)
研究者
Barry Finegan
MB, FFARC, FRCPC
University of Alberta