Combined Application of Remote and Intra-Coronary Ischemic Conditioning in Acute Myocardial Infarction: A Multicenter, Randomized, Controlled Clinical Trial (CARIOCA Study)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 750
- 试验地点
- 6
- 主要终点
- Combined incidence of [all-cause mortality; worsening of heart failure during initial hospitalization or re-hospitalization for heart failure at 6 months after MI, large infarct defined as CK peak at 6 hours > 4500 UI/L]
研究概览
简要总结
Infarct size is a major determinant of prognosis after AMI. Evidence indicates that the combination of intracoronary ischemic conditioning (ICIC) and remote ischemic conditioning (RIC) can significantly reduce infarct size in STEMI patients. Whether the combination of these two interventions may improve clinical outcome after STEMI remains unknown. The objective of the present study is to determine whether combination of ICIC and RIC can improve STEMI patients clinical outcome at 6 months.
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 (Outcomes Assessor)
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
- •All (male and female) patients, aged over 18,
- •Presenting within 12 hours of the onset of chest pain,
- •For whom the clinical decision was made to treat with percutaneous coronary intervention (PCI),
- •ST segment elevation ≥ 0.2 mV in two contiguous ECG leads,
- •Written informed consent obtained or oral informed consent certified by a third party.
- •Non inclusion Criteria:
- •Patients with cardiogenic shock,
- •Patients with uncontrolled (treated or untreated) hypertension (> 180/110 mmHg),
- •Patients with loss of consciousness or confused,
- •Patients without health coverage,
- •Patient with any legal protection measure,
- •Female patients currently pregnant (oral diagnosis) or women of childbearing age who were not using contraception.
排除标准
- •Patients with main occlusion localized on :
- •LAD: distal or ostial segment,
- •Non dominant RCA / CX: mid or distal segment,
- •Dominant RCA / CX: distal segment,
- •Any other arteries apart LAD/CX/RCA; Patients with evidence of coronary collaterals to the risk region (Rentrop score ≥ 2); Patients with an opened (TIMI > 1) culprit coronary artery on initial admission coronary angiography or a failed PCI (final TIMI=0).
研究组 & 干预措施
RIC+ ICIC +
Patients with remote ischemic conditioning and intracoronary ischemic conditioning
干预措施: Remote ischemic conditioning and intracoronary ischemic conditioning (Device)
RCI - ICIC -
Control group with no remote ischemic conditioning and no intracoronary ischemic conditioning
干预措施: Patients with no remote ischemic conditioning and no intracoronary ischemic conditioning (Device)
结局指标
主要结局
Combined incidence of [all-cause mortality; worsening of heart failure during initial hospitalization or re-hospitalization for heart failure at 6 months after MI, large infarct defined as CK peak at 6 hours > 4500 UI/L]
时间窗: 6 months
次要结局
- Worsening of heart failure(6 months)
- Cardiovascular death at 6 months.(6 months)
- Time to first event [all-cause mortality; worsening of heart failure during initial hospitalization or re-hospitalization for heart failure](6 months)
- Rate of CRP(5 days)
- Peak of creatine kinase(4-6 hours post-PCI)
- creatine kinase(5 days)
- Measure hsCRP(5 days)
- Major Adverse Cardiac Events (MACE)(6 months)
- Renal failure(6 months)