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Palmar Arch Insufficiency as a Risk Factor for Radial Artery Occlusion After Transradial Catheterization (PAIRAO)

2021年7月26日 更新者:University Hospital Inselspital, Berne

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

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.

研究概览

地位

完全的

研究类型

观察性的

注册 (实际的)

200

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Bern、瑞士、3010
        • University Hospital Inselspital, Bern

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Patients electively referred for coronary angiography undergoing transradial access

描述

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
Normal modified Allen Test
Patients undergoing transradial coronary angiography with a modified Allen-Test ≤ 15 seconds
Abnormal modified Allen Test
Patients undergoing transradial coronary angiography with a modified Allen-Test > 15 seconds

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Radial artery occlusion
大体时间:3 months after transradial coronary angiography
Frequency of radial artery occlusion after transradial coronary angiography; assessed by Doppler ultrasound measurements
3 months after transradial coronary angiography

次要结果测量

结果测量
措施说明
大体时间
Palmar arch collateral circulation
大体时间: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
Quantitatively measure of the pressure-derived function of the palmar collateral circulation during transradial catheterization. Assessment of the collateral function by setting the invasively obtained blood pressure during external occlusion in relation to the unaffected blood pressure of the radial artery.
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
大体时间:3 months after transradial coronary angiography
Frequency of radial artery stenosis after transradial coronary angiography; assessed by Doppler ultrasound measurements
3 months after transradial coronary angiography

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2018年1月25日

初级完成 (实际的)

2021年7月1日

研究完成 (实际的)

2021年7月1日

研究注册日期

首次提交

2019年6月18日

首先提交符合 QC 标准的

2019年6月18日

首次发布 (实际的)

2019年6月21日

研究记录更新

最后更新发布 (实际的)

2021年7月27日

上次提交的符合 QC 标准的更新

2021年7月26日

最后验证

2021年7月1日

更多信息

与本研究相关的术语

药物和器械信息、研究文件

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研究美国 FDA 监管的设备产品

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