Femoral Versus Radial Access for Coronary Intervention in the Acute Phase of ST-Elevation Myocardial Infarction
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 439
- 试验地点
- 6
- 主要终点
- All cause mortality at 30 days
研究概览
简要总结
The aim of this study is to compare the radial and femoral access for percutaneous interventions in the acute phase of the ST elevation acute myocardial infarction in terms of efficacy and security.
详细描述
Some groups have previously used the radial artery as the access route in the procedures of percutaneous coronary revascularization, with good results. The advantages of the radial compared with femoral access are related to a lower incidence of vascular complications. The radial access has also inconveniences such as a less predictable anatomy which can make the procedure difficult and prolong the time required.The patients with ST elevation myocardial infarction have an increased risk of vascular complications after interventional procedures because previous antithrombotic or thrombolytic therapy.On the other hand, the time and success of the procedure are significant prognostic issues.In this sitting, the radial approach might reduce vascular complications and increase other cardiovascular events when comparing with the classical femoral access. For this reason, the purpose of the study is to compare both arterial access in terms of efficacy and security and to quantify the consequences of the advantages and drawbacks of both.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with ST elevation acute myocardial infarction referred for primary,facilitated or of rescue coronary angioplasty in the first 12 hours since the start of the symptoms.
排除标准
- •Patients in cardiogenic shock were excluded following operator criteria.
- •Previous coronary surgery with mammary artery graft
- •Coronary artery intervention in the previous month
- •Absolute or relative contraindication for access via the radial artery route:Radial pulse absent or weak, abnormal Allen test,anatomy known to impede the use of the radial route or hemodialysis or advanced chronic renal insufficiency (creatinine >3 mg/dl).
- •Patients with absolute or relative contraindication for the use of the femoral route.
- •Absence of informed consent from the patient
结局指标
主要结局
All cause mortality at 30 days
时间窗: within the first 30 days (plus or minus 5 days) after the index myocardial infarction
New ST elevation acute myocardial infarction at 30 days
时间窗: within the first 30 days (plus or minus 5 days) after the index myocardial infarction
Coronary revascularization as a result of recurrent ischemia at 30 days
时间窗: within the first 30 days (plus or minus 5 days) after the index myocardial infarction
Major vascular complications at 30 days.
时间窗: within the first 30 days (plus or minus 5 days) after the index myocardial infarction
次要结局
- Embolic stroke at 30 days(within the first 30 days (plus or minus 5 days) after the index myocardial infarction)
- Coronary revascularization at 30 days(within the first 30 days (plus or minus 5 days) after the index myocardial infarction)
- Cardiovascular mortality at 30 days(within the first 30 days (plus or minus 5 days) after the index myocardial infarction)
- Procedural time
- Hospital stay
- Estimation of costs