Randomized Comparison of Combined Remote Ischemic Conditioning and Local Postconditioning Compared to Standard Treatment in High-risk ST-elevation Myocardial Infarction Patients
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 250
- 试验地点
- 19
- 主要终点
- Composite of all-cause mortality or hospitalization for heart failure (HF) within 12 months after randomization.
研究概览
简要总结
The RIP-HIGH trial is a two-arm randomized controlled trial aiming to compare the impact of combined remote ischemic conditioning (RIP) and local ischemic postconditioning (PostC) vs. standard of care on clinical outcome in high-risk ST-elevation myocardial infarction patients undergoing primary percutaneous coronary intervention.
详细描述
Coronary reperfusion by percutaneous coronary intervention is mandatory to salvage ischemic myocardium and to reduce definite infarct size. However, reperfusion itself also causes irreversible myocardial damage - a phenomenon described as reperfusion injury. Reduction of ischemic and reperfusion injury by ischemic conditioning has been identified as a potential target to reduce myocardial damage.
Remote ischemic conditioning and local ischemic postconditioning might be in particular of clinical benefit in higher risk STEMI patients with Killip class ≥2, where mortality rates are high.
The Remote Ischemic Conditioning with Local Ischemic Postconditioning in High-Risk ST-elevation myocardial infarction patients (RIP-HIGH) trial is a two-arm randomized controlled trial aiming to compare the impact of combined remote ischemic conditioning and local ischemic postconditioning vs. standard of care on clinical outcome in high-risk ST-elevation myocardial infarction patients undergoing primary percutaneous coronary intervention.
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
- None
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
- •Acute chest pain lasting <12 h
- •ST-elevation at the J-point in two contiguous leads of ≥2 mm in men ≥40 years, ≥2.5 mm in men <40 years and ≥1.5 mm in women (regardless of age) in V2-V3 and/or ≥1 mm in all other leads (52).
- •New or presumed new left bundle branch block or right bundle branch block.
- •Killip class ≥II on hospital admission or requirement of diuretics because of clinical congestion.
- •Written informed consent.
排除标准
- •Killip class I on hospital admission.
- •Prior fibrinolysis.
- •Conditions precluding use of RIC (i.e. paresis of the upper limb, presence of an arteriovenous shunt).
- •Pregnancy.
- •Age <18 years.
- •Severe co-morbidity with a life expectancy <6 months.
- •Participation in another trial.
结局指标
主要结局
Composite of all-cause mortality or hospitalization for heart failure (HF) within 12 months after randomization.
时间窗: 12 months
次要结局
- Hospitalization for heart failure at 12 months(12 months)
- Cardiovascular mortality at 12 months.(12 months)
- All-cause mortality at 12 months(12 months)
- Composite of all-cause mortality, HF hospitalization and survived out-of-hospital cardiac arrest at 12 months(12 months)
- Thrombolysis in myocardial infarction (TIMI)-flow grade of the culprit vessel post PCI(day 0)
- Proportion of patients showing complete (≥70%) resolution of ST-segment elevation 60 minutes after reperfusion(day 0)
- all-cause mortality, HF hospitalization and survived out-of-hospital cardiac arrest assessed at 5 years via telephone contact.(5 years)
- CMR-derived infarct size.(day 2-5)
- CMR-derived myocardial salvage index(day 2-5)
- Enzymatic infarct size defined as high-sensitivity cardiac troponin T (hs-TnT) levels 72 h after randomization(day 3)
- Change in N-terminal pro B-type natriuretic peptide (NT-proBNP) levels during admission and 72 h after randomization(day 0, day 3)
- Extent of CMR-derived late microvascular obstruction on day 2-5 after randomization(day 2-5)