ST Elevation Myocardial Infarction Treated by RADIAL or Femoral Approach - Randomized Multicenter Study Comparing Radial Versus Femoral Approach in Primary PCI. The STEMI-RADIAL Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 707
- 试验地点
- 8
- 主要终点
- Occurrence of bleeding or entry site complications
研究概览
简要总结
Percutaneous coronary interventions (PCIs) from the femoral approach have more bleeding complications related to access site in comparison to the radial approach in patients with acute coronary syndrome (ACS). Major bleeding and access site complications have an important role in results of PCI for ACS and lead to higher morbidity and mortality. Primary PCIs in ST elevation myocardial infarction (STEMI) are associated with more aggressive antithrombotic treatment than in elective or semi-urgent interventions. Currently, both radial and femoral approaches are routinely used for primary PCI in STEMI. However, only non-randomized studies and registries or small randomized single center studies comparing both approaches in primary PCI have been published until now. The aim of STEMI-RADIAL trial is to evaluate potential reduction of bleeding complications in the radial approach primary PCI compared to femoral approach in randomized, multicenter study.
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
- •Age over 18 years
- •Admission for STEMI less than 12 hours after onset of symptoms
- •Patients have typical chest pain for at least 20 minutes and have ECG changes typical for STEMI (ST elevation ≥ 2 mm in two continuous precordial leads or ST elevations ≥ 1 mm in two limb leads or new left bundle branch block) or ECG changes compatible with true posterior MI.
- •Patients are planned to be treated with primary PCI
- •Ability to sign written informed consent
排除标准
- •Killip IV class or unconsciousness
- •Patient disagreement
- •Prior aortobifemoral bypass
- •Absence of both radial or femoral artery pulsation
- •Participation in another clinical trial randomizing ACS patients using antithrombotic drug.
- •Negative Allen's test or Barbeau test type D
- •Treatment with oral anticoagulants
结局指标
主要结局
Occurrence of bleeding or entry site complications
时间窗: 30 days
次要结局
- Angiographical procedural success
- Contrast media consumption
- Procedural and fluoroscopic times
- Duration of hospital / ICU stay
- TVR/TLR + any new hospitalization
- Occurence of major adverse cardiovascular events
- Primary access site failure - conversion to another access
研究者
Ivo Bernat
MD, PhD
Charles University, Czech Republic