Effect of Single-cycle Remote Ischemic Preconditioning and Postconditioning on Myocardial Injury in Patients Undergoing Emergency and Elective Percutaneous Intervention in Phramongkutklao Hospital and Thammasat University
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 370
- 试验地点
- 2
- 主要终点
- Change in cardiac Troponin-T from baseline
研究概览
简要总结
This trial is a 2 x 2 factorial design, double-blinded, randomized controlled trial to evaluate efficacy and safety of remote ischemic preconditioning and postconditioning in patient undergoing coronary angioplasty.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, 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
- •Eligible for percutaneous coronary intervention (elective and emergency cases)
- •Age > 18-year-old
- •Informed consent
排除标准
- •Previous CABG
- •Previous PCI in 1 week / treatment with thrombolysis within 30 days
- •Peripheral arterial disease / A-V shunt of upper extremities (AVF for hemodialysis)
- •Paresis of upper limb
- •Unstable patient such as cardiogenic shock / vasopressor / IABP / cooling (hypothermia)
- •Fatal cardiac arrhythmia (VT / VF)
- •Chronic hypoxia
研究组 & 干预措施
RIPre + RIPost
Intervention: RIPre 200 mmHg + RIPost 200 mmHg
干预措施: RIPre (Procedure)
RIPre + RIPost
Intervention: RIPre 200 mmHg + RIPost 200 mmHg
干预措施: RIPost (Procedure)
RIPre + Sham
Intervention: RIPre 200 mmHg + Sham 10 mmHg
干预措施: RIPre (Procedure)
RIPre + Sham
Intervention: RIPre 200 mmHg + Sham 10 mmHg
干预措施: Sham-Post (Procedure)
Sham + RIPost
Intervention: Sham 10 mmHg + RIPost 200 mmHg
干预措施: Sham-Pre (Procedure)
Sham + RIPost
Intervention: Sham 10 mmHg + RIPost 200 mmHg
干预措施: RIPost (Procedure)
Sham + Sham
Intervention: Sham 10 mmHg + Sham 10 mmHg
干预措施: Sham-Pre (Procedure)
Sham + Sham
Intervention: Sham 10 mmHg + Sham 10 mmHg
干预措施: Sham-Post (Procedure)
结局指标
主要结局
Change in cardiac Troponin-T from baseline
时间窗: within 24 hours
次要结局
- Major adverse cardiovascular events (MACE) in each intervention group(6 months)
- Incidence of myocardial injury(within 24 hours)
- Incidence of myocardial injury in differrent subgroups of patient characteristics(within 24 hours)
- Incidence of MACE in differrent subgroups of patient characteristics(6 months)
- Incidence of MACE in patients with vs. without RIPre and RIPost(6 months)
- Incidence of MACE in patients who have myocardial injury vs. patients who have no myocardial injury(6 months)
- Incidence of myocardial injury in patients with vs. without RIPre and RIPost(24 hours)