Remote Myocardial Ischemic Preconditioning in Humans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 156
- 试验地点
- 2
- 主要终点
- Post PCI myonecrosis measured as a maximum troponin T ≥0.03
研究概览
简要总结
Ischemic preconditioning (IP) has been shown in animal studies to increase the myocardial tolerance to subsequent ischemia. Our primary hypothesis is that remote IP reduces myocardial ischemic injury during PCI.
详细描述
Our primary hypothesis is that remote IP reduces myocardial ischemic injury during PCI. We will also test the hypotheses that IP diminishes the inflammatory response to PCI, and that higher baseline blood endothelial progenitor cell counts are predictive of a favorable response to IP.
Aim 1: To evaluate whether remote ischemic preconditioning reduces the frequency of myonecrosis (troponin T≥0.03 ng/ml following PCI).
Aim 2: To evaluate whether remote ischemic preconditioning reduces the inflammatory response to PCI (post PCI hsCRP level).
Aim 3: To evaluate whether pre-procedure circulating endothelial progenitor cell counts correlate with the effect of remote ischemic preconditioning on myonecrosis.
Background: Percutaneous coronary intervention (PCI) frequently results in ischemic myonecrosis. Ischemic preconditioning (IP) has been shown in animal studies to increase the myocardial tolerance to subsequent ischemia. Our primary hypothesis is that remote IP reduces myocardial ischemic injury during PCI.
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 (Investigator)
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
- •Patients will be eligible for randomization if they meet the following criteria:
- •Age ≥ 18 years
- •Clinically indicated elective or urgent PCI
排除标准
- •Patients will be ineligible for the study if one or more of the following conditions exist:
- •Pre-PCI Troponin T ≥ 0.03
- •Systemic hypotension (systolic <90 mmHg) or cardiogenic shock
- •Presence of an arteriovenous fistula or lymphedema of either arm
- •Currently enrolled in other active cardiovascular investigational studies
- •Severe endocrine, hepatic, renal, disorders
- •Pregnancy or lactation
- •Inability to provide consent
- •Federal Medical Center inmates
- •Inability or unwillingness to provide informed consent
研究组 & 干预措施
1
Arm ischemia will be induced using a blood pressure cuff that will be placed around the upper part of the arm, and inflated to 200 mm Hg for 3-minutes and then deflated for 3-minutes
干预措施: Blood pressure cuff (Device)
2
3-cycles of cuff inflation (10 mmHg)-deflation will also be performed in the control group for similar durations without inducing ischemia
干预措施: blood pressure cuff (Device)
结局指标
主要结局
Post PCI myonecrosis measured as a maximum troponin T ≥0.03
时间窗: 16 hours post PCI
次要结局
- Post PCI myonecrosis measured as an elevation in creatine kinase MB fraction (CK-MB> 1 X upper limit of normal)(16 hours post procedure)
- Magnitude of ST segment elevation on an intracoronary electrocardiogram during balloon inflation(During PCI procedure)
- Coronary perfusion measured as coronary flow reserve derived from TIMI frame counts(During PCI)
- Blood high sensitivity C-reactive protein level(Immediately prePCI)
- Blood endothelial progenitor cell counts (EPC)(Immediately prePCI)
研究者
Abhiram Prasad
Professor of Medicine
Mayo Clinic