NCT04301921Unknown不适用
Strategies to Maintain Radial Artery Patency Following Diagnostic Coronary Angiography - Diagnostic Transradial Coronary Angiography Without Systemic Anticoagulatio
Prof. Dr. med. Ingo Eitel0 个研究点目标入组 400 人开始时间: 2020年5月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 400
- 主要终点
- Bleeding events
研究概览
简要总结
To investigate whether omitting systemic anticoagulation during transradial coronary angiography and/or a distal radial access reduce the risk of postprocedural radial artery occlusion
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Clinical indication to perform diagnostic coronary angiography
- •Age > 18 years
- •Written informed consent
排除标准
- •Preexisting or already administered anticoagulation prior to coronary angiography
- •Planned coronary intervention
- •Preexisting radial artery occlusion or missing pulse at the potential puncture sites
- •Allergy / intolerance to anticoagulants
- •Active bleeding or comorbidity with elevated bleeding risk
- •Pregnancy
- •Inability to sign informed consent
- •Participation in another trial
结局指标
主要结局
Bleeding events
时间窗: Day 1
Will be bleeding events according to Bleeding Academic Research Consortium (BARC) criteria.
Occurrence of postprocedural RAO
时间窗: Day 1
Will be the occurrence of postprocedural RAO assessed with high-resolution vascular ultrasound. Experienced sonographers will perform color Doppler ultrasound in all study patients after removal of the compression device to examine the radial, ulnar, and brachial arteries of the access forearm.
次要结局
- Sonographic characteristics of radial artery occlusion(3 Month)
研究者
Prof. Dr. med. Ingo Eitel
Senior physician
University of Luebeck
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