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

NCT03993834 | Completed

• 1 other identifier: 2017-00622
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

Transradial catheterization; Transradial access; Radial artery occlusion; Palmar arch collateral circulation; Collateral flow index

Outcome Measures

Primary Outcomes (1)

• Radial artery occlusion

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

  3 months after transradial coronary angiography

Secondary Outcomes (2)

• 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

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients electively referred for coronary angiography undergoing transradial access

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

University Hospital Inselspital, Bern

Bern, 3010, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 35065801 DERIVED

Related 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.

MeSH Terms

Conditions

Coronary Artery Disease; Arterial Occlusive Diseases

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Vascular Diseases

Study Officials

• Christian Seiler, MD, Prof

  Inselspital, Bern University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2019
• First Posted: June 21, 2019
• Study Start: January 25, 2018
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: July 27, 2021

Record last verified: 2021-07

Locations

CH (1)