Effects of Long-term Remote Ischemic Preconditioning on Clinical Outcome in Patients With Acute Myocardial Infarction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,146
- 试验地点
- 1
- 主要终点
- Rate of MACCEs
研究概览
简要总结
At present, there are 290 million cardiovascular patients in China, including 11 million patients with coronary heart disease. Remote ischemic preconditioning(RIPC) may play an effective endogenous cardiac protection.This study will explore whether long-term use of RIPC in patients with AMI after PCI and non interventional therapy can reduce the incidence of major adverse cardiovascular cerebrovascular events(MACCE) and improve clinical outcomes and long-term prognosis.
详细描述
A total of 2146 patients with AMI are expected included as the research objects and randomly divided into experimental group and control group with 1073 cases in each group. After admission, Patients in the experimental group received everyday RIPC of upper limbs to the end of follow-up.The control group is a blank control and undergoes conventional medical procedures. Routine blood indexes, ultrasound, electrocardiogram, were detected On the day of admission. 12 months post- discharge, the incidence of MACCE(include Cardiovascular death, non-fatal acute myocardial infarction, stent thrombosis, revascularization, stroke, admission due to heart failure and the above composite events were independent components) and Poce(All deaths, all strokes, all myocardial infarction, or all revascularization events)will recorded by telephone follow-up.
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
- •Patients with acute myocardial infarction were diagnosed in accordance with the criteria of the "Global Unified Definition of Fourth Myocardial Infarction"
排除标准
- •The patients could not tolerate RIPC or RIPerC
- •Aortic dissection, coronary artery aneurysm, coronary artery fistula and other systemic organic diseases
- •The uncontrolled systolic blood pressure and diastolic blood pressure of severe hypertension were 180 mmHg and 120 mmHg respectively
- •severe liver dysfunction (bilirubin > 20 mmol / L, prothrombin time > 2.0 ratio)
- •Severe renal insufficiency (GFR < 30 ml / min / 1.73 m2);
- •patients taking nicorandil and other drugs affecting microcirculation
研究组 & 干预措施
Experimental Group1（RIPerC+RIPC）
Remote ischemic PERconditioning was initiated immediately after the diagnosis of acute myocardial infarction， and Remote ischemic PREconditioning was performed daily after discharge
干预措施: RIPerC (Other)
Experimental Group1（RIPerC+RIPC）
Remote ischemic PERconditioning was initiated immediately after the diagnosis of acute myocardial infarction， and Remote ischemic PREconditioning was performed daily after discharge
干预措施: RIPC (Other)
Experimental Group2（RIPerC）
Remote ischemic PERconditioning was initiated immediately after the diagnosis of acute myocardial infarction
干预措施: RIPerC (Other)
Control group
A group of patients who received conventional treatment without any additional intervention
结局指标
主要结局
Rate of MACCEs
时间窗: 12 months after discharge
MACCE(include Cardiovascular death, non-fatal acute myocardial infarction, revascularization, stroke, admission due to heart failure )
次要结局
- Rate of Cardiovascular death events(12 months after discharge)
- Rate of non-fatal acute myocardial infarction events(12 months after discharge)
- Rate of revascularization events(12 months after discharge)
- Rate of stroke events(12 months after discharge)
- Rate of admission due to heart failure events(12 months after discharge)
- Rate of all all-cause death events(12 months after discharge)