Distal Radial Artery Access in Comparison to Forearm Radial Artery Access for Cardiac Catheterization, a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 212
- 试验地点
- 1
- 主要终点
- Radial artery occlusion
研究概览
简要总结
The Distal Radial Access (DRA) to the coronaries has emerged recently. It's done via the distal radial artery in the radial fossa, which is known as the snuff-box. The rationale of conducting this research is to assess this new access advantages and disadvantages, in comparison with the standard conventional forearm radial access and examine if it's worthy to be a future alternative method for coronary angiography. It aims to randomly compare between the new distal radial access via the snuffbox and the conventional forearm radial access for percutaneous coronary angiography and angioplasty procedures. The objectives of comparing both procedures are to analyze the frequency of complications in terms of occlusion, arterial spasm, hematoma, and to weigh accesses effectiveness in terms of time and attempts to puncture, crossover rate, procedure duration, hemostasis time, and convenience of the patients and operators.
Candidates for coronary angiography are being randomized into the interventional group to undergo the angiography through the distal radial artery as the access site, or the control group accessing through the radial artery in the forearm. Procedural and post procedural outcomes and complications are being reported while patients are in hospital. All patients undergo doppler ultrasonography within 24 hours after the 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
- Single (Outcomes Assessor)
盲法说明
Patients enrolled to the study were randomized into Forearm Radial or Distal Radial groups. Care providers operated on patients and investigators collected their data during and after the operation. The independent variable - Access site (Forearm Radial or Distal Radial) - was coded into X or Z groups, then data was sent to the outcomes assessor.
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
- •Patients who agree to participate in the study and sign the consent form.
- •Patients with an indication for coronary catheterization
- •Clinically stable patients
- •Patients with palpable pulses on both access sites of the radial artery.
排除标准
- •Patients with STEMI
- •Patients with radial AV shunt for hemodialysis
- •Patients with previous CABG using radial artery
- •Patients with previous CABG using LIMA, RIMA or both.
- •Patients with Renaud phenomenon or lymphedema
结局指标
主要结局
Radial artery occlusion
时间窗: Within 24 hours after the procedure.
Doppler Ultrasonography of the radial artery for occlusions along its course, in both groups.
次要结局
- Puncture Time(During the procedure)
- Puncture Attempts(During the procedure)
- Procedure Duration(During the procedure)
- Radiation Duration(During the procedure)
- Radiology Dose(During the procedure)
- Compression "hemostasis" time(Up to 240 minutes after band placement)
- Arterial spasm(During the procedure)
- Hematoma and bleeding complications(Within 24 hours after the procedure)
- Crossover (failure to puncture)(During the procedure)
- Procedural pain(During the procedure)
- Radial Artery Occlusion on follow up(After 2 weeks of the procedure.)
- Ischemic changes to the hand(Within 24 hours after the procedure)
- Post-procedural pain(Within 24 hours after the procedure)
- Rare complications(Within 24 hours after the procedure)
研究者
Yunis Daralammouri
Assistant Professor
An-Najah National University