Adverse Clinical Outcomes Associated With Conventional Versus Distal Radial Access in Patients With Acute Coronary Syndrome With ST-segment Elevation Treated by Percutaneous Coronary Intervention
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,922
- 试验地点
- 1
- 主要终点
- Composite of adverse events of all-cause mortality, myocardial infarction, cerebral vascular event, BARC 3-5 (Bleeding Academic Research Consortium), myocardial infarction and cerebrovascular event, bleeding measure will be with BARC classification.
研究概览
简要总结
This clinical trial aims to compare conventional radial access versus distal radial access in patients with STEMI undergoing PCI. The main question it aims to answer is:
• Mayor adverse cardiac events (MACE) at 30 days in STEMI patients treated by PCI are not inferior when comparing the distal radial approach versus the conventional radial approach ?
Participants will:
- sign the informed consent to enroll in the clinical trial.
- will agree to be treated by PCI
- will be randomized 1:1 to perform PCI by conventional radial or distal radial approach.
If there is a comparison group:
Researchers will compare conventional radial access vs distal radial access to see if the distal approach is not inferior compared to the conventional radial access in order to offer less or equal MACE and a similar rate of a successful procedure.
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
- •STEMI patients underwent PCI.
- •Patent radial access (distal and conventional)
- •Patients who agree to participate in the study and sign the informed consent form.
排除标准
- •Cardiogenic shock.
- •Previous coronary artery bypass grafting (CABG).
- •Absence of palpable radial pulse.
- •Arteriovenous fistula for hemodialysis.
- •Previous radial artery occlusion.
结局指标
主要结局
Composite of adverse events of all-cause mortality, myocardial infarction, cerebral vascular event, BARC 3-5 (Bleeding Academic Research Consortium), myocardial infarction and cerebrovascular event, bleeding measure will be with BARC classification.
时间窗: 24 hours and 30 days after PCI.
At 24 hours and 30 days after the procedure, patients will be evaluated by radial doppler ultrasonography, lab test, and interrogation of clinical adverse events during hospital stay or 30 days after PCI.
次要结局
- Incidence of cerebral vascular event (hemorrhagic or ischemic stroke) after the procedure(24 hours to 30 days after PCI.)
- Incidence of myocardial infarction after the procedure(24 hours to 30 days after PCI)
- Bleeding assessed by BARC 3-5 to 30 days of evolution in patients with STEMI who received interventional treatment via RD access versus RC access.(24 hours to 30 days after PCI.)
- Definite stent thrombosis(If the patient requires repeat catheterisation for myocardial infarction within the first 30 days after PCI.)
- Urgent TVR (Revascularization of the treated vessel)(If the patient requires repeat catheterisation for myocardial infarction within the first 30 days after PCI.)
研究者
Guering Eid Lidt
Director of Cardiac Catheterization Lab
Instituto Nacional de Cardiologia Ignacio Chavez