Cardio- and Reno-protective Effect of Remote Ischemic Preconditioning in Patients Undergoing Percutaneous Coronary Intervention. A Prospective, Non-randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Incidence of PCI- related myocardial infarction (MI 4a) at 24 hours after PCI.
研究概览
简要总结
Myocyte necrosis occurs frequently in elective percutanious percutaneous coronary intervention (PCI) and is associated with subsequent cardiovascular events. This study assessed the cardio- and reno-protective effect of remote ischemic preconditioning (RIPC) in patients undergoing elective PCI. 200 patients were randomized into 2 groups: 100 patients received RIPC (created by three 5-minute inflations of a blood pressure cuff to 200 mm Hg around the upper arm, separated by 5-minute intervals of reperfusion) < 2 hours before the PCI procedure, and the control group (n = 100).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between 18 and 85 years of age,
- •scheduled to undergo an elective PCI and
- •able to give an informed consent were eligible for enrollment in the study.
- •Elective PCI was defined as any coronary revascularization in a low-risk patient who presents to the facility for a planned PCI or for a coronary angiogram followed by ad hoc PCI.
排除标准
- •(1) emergency PCI, (2) baseline troponin value ≥ 0.04 ng/mL, (3) nicorandil or glibenclamide use (preconditioning-mimetic and preconditioning-blocking medication, respectively), (4) those who could not give informed consent, and (5) patients with severe renal impairment or on regular dialysis.
研究组 & 干预措施
RIPC (Remote Ischemic Pre-Conditioning)
Patients used RIPC had a blood pressure cuff placed around their upper arm at < 2 hours before the PCI procedure. The blood pressure cuff was inflated to for 5 minutes, followed by 5 minutes of deflation. This procedure was repeated 3 times
干预措施: Remote Ischemic Pre-Conditioning (Other)
Control
Control participants did not experience this procedure of transient upper-limb ischemia.
干预措施: Remote Ischemic Pre-Conditioning (Other)
结局指标
主要结局
Incidence of PCI- related myocardial infarction (MI 4a) at 24 hours after PCI.
时间窗: 24 hours
PCI-related myocardial infarction (MI 4a) was defined as cardiac Troponin I (cTnI) elevation \>0.20ng/mL (5 times the upper reference limit) 24 hr. post PCI.
次要结局
- incidence of contrast induced nephropathy (CIN) at 72 hours after contrast exposure(72 hours)
研究者
Ayman Khairy Mohamed Hassan
Dr.
Assiut University