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

Coronary Artery Disease Clinical Trial

— PAIRAO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03993834
• Other study ID #: 2017-00622
• Status: Completed
• Start date: January 25, 2018
• Est. completion date: July 1, 2021

Study information

• Verified date: July 2021
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: July 1, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease

Locations

Country	Name	City	State
Switzerland	University Hospital Inselspital, Bern	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radial artery occlusion	Frequency of radial artery occlusion after transradial coronary angiography; assessed by Doppler ultrasound measurements	3 months after transradial coronary angiography
Secondary	Palmar arch collateral circulation	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
Secondary	Radial artery stenosis	Frequency of radial artery stenosis after transradial coronary angiography; assessed by Doppler ultrasound measurements	3 months after transradial coronary angiography

External Links

•   Jolly SS et al. Lancet 2011 - Radial versus femoral access for coronary angiography and intervention in patients with acute coronary syndromes (RIVAL): a randomised, parallel group, multicentre trial.
•   Kotowycz and Džavík Circulation Cardiovascular Interventions 2012 - Radial Artery Patency After Transradial Catheterization