跳至主要内容
临床试验/NCT03993834
NCT03993834已完成不适用

Palmar Arch Insufficiency as a Risk Factor for Radial Artery Occlusion After Transradial Catheterization - a Single-Centre Observational Study

Insel Gruppe AG, University Hospital Bern1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2018年1月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
200
试验地点
1
主要终点
Radial artery occlusion

研究概览

简要总结

Transradial access (TRA) is commonly used in different medical fields due to the superficial position of the radial artery and related advantages. Despite its popularity, the incidence and importance of related complications, in particular, radial artery occlusion (RAO) remains unclear. Further, the only known independent predictors of the radial artery occlusion are the periprocedural anticoagulation as well as the catheter size. The effect of a variable arterial anatomy has so far not been evaluated.

In this context, most institutions prefer to evaluate the collateral circulation of the hand, i.e., the arterial palmar arch and forearm circulation before TRA. The most commonly employed tests are the modified Allen test (MAT) or the combination of pulse oximetry and plethysmography according to Barbeau.In addition, there are more precise, but still semi-quantitative non-invasive methods for palmar arterial collateral function testing.

Despite the wealth of these variably accurate and practical tests, invasive and direct hemodynamic measurement of the arterial forearm circulation and its components is lacking. Thus, the human physiologic circulatory reference at this site has been unknown so far. Further, the need of pre-procedural testing itself can be questioned in light of the reported, widely varying prevalence of RAO (1-38%) or critical ischemia (0-0.09%) after TRA.

The present study investigated in a first step the invasively obtained, pressure-derived hemodynamic function, i.e., the physiology of the human arterial palmar arch and forearm collateral circulation and in a second step the clinical consequences of the variable palmar arterial anatomy.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age > 18 years
  • Patient receiving transradial coronary angiography and undergoing evaluation of the palmar arterial arch circulation as a quality control
  • Written informed consent to participate in the follow-up Doppler ultrasound examination

排除标准

  • Changed anatomical conditions of the radial artery, e.g. after coronary artery bypass surgery with radial harvest

结局指标

主要结局

Radial artery occlusion

时间窗: 3 months after transradial coronary angiography

Frequency of radial artery occlusion after transradial coronary angiography; assessed by Doppler ultrasound measurements

次要结局

  • Palmar arch collateral circulation(Measured during transradial access of the coronary angiography, expected to be 1 minute after local anesthesia and direct after successful punctuation of the radial artery)
  • Radial artery stenosis(3 months after transradial coronary angiography)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验