Clinical trial NCT03993834: Palmar Arch Insufficiency as a Risk Factor for Radial Artery Occlusion After Transradial Catheterization
Official title: Palmar Arch Insufficiency as a Risk Factor for Radial Artery Occlusion After Transradial Catheterization - a Single-Centre Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: Transradial catheterization
Transradial access
Radial artery occlusion
Palmar arch collateral circulation
Collateral flow index
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2019-06-21
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients electively referred for coronary angiography undergoing transradial access

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Radial artery occlusion
timeFrame: 3 months after transradial coronary angiography
Secondary outcomes:
measure: Palmar arch collateral circulation
timeFrame: 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
measure: Radial artery stenosis
timeFrame: 3 months after transradial coronary angiography
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: University Hospital Inselspital, Bern
Study officials:
affiliation: Inselspital, Bern University Hospital
name: Christian Seiler, MD, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bigler MR, Buffle E, Rappo MV, Grossenbacher R, Tschannen C, Seiler C. Association of Palmar Arch Collateral Function and Radial Artery Occlusion After Transradial Access. Am J Cardiol. 2022 Apr 1;168:151-158. doi: 10.1016/j.amjcard.2021.12.020. Epub 2022 Jan 20.