Association Between Radial Artery Intervention and Development of Neuropathy in the Hand - A Prospective Study

Recruiting

• Conditions: Carpal Tunnel Syndrome; Ischemic Heart Disease; Nerve Injury

• Registration Number: NCT05365282
• Lead Sponsor: Aarhus University Hospital Skejby

Brief Summary

Evaluation of potential nerve damage after radial CAG/PCI.

Detailed Description

Prospective patients scheduled for radial CAG/ PCI will be enrolled in the study. Prior to the procedure, sensory and motor nerve examination is performed at the wrists in both arms / hands. The examination is performed on both the median nerve and the ulnar nerve. Each patient acts as their own control. The nerve test is repeated bilaterally 1 month after the procedure. This creates 2 groups, A and B.

Patients will be asked to complete 2 questionnaires in relation to hand and arm symptoms. The patients ability to perform certain activities before and after the CAG/PCI procedure are also addressed. In addition, a diagnostic tool (Katz chart) will be completed, also before and after the CAG/PCI procedure.

Hypothesis:

Radial access is associated with an increased risk of pain and an increased incidence of nerve damage similar to the median nerve at the carpal tunnel or the ulnar nerve at the Guyon's canal.

Study Timeline

• Study First Submitted: 2022-05-04
• Study First Submitted QC: 2022-05-04
• Study First Posted: 2022-05-09
• Study Start: 2024-01-01
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-01
• Last Update Posted: 2025-01-03
• Primary Completion: 2026-03-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• The patient must be able to give informed consent

Exclusion Criteria

• Pregnancy
• Negative Barbeau test

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Neurophysiological measurements	Aprox 1 hour	The primary aim is the incidence/presence of electrofysiological signs of median and/or ulnar nerve lesion at the wrist and the presence of carpaltunnel syndrom.; The electrodiagnosis of carpaltunnelsyndrom will be determined from the clinical picture and signs of prolonged distal motor lantency and reduced motor and sensory nerveconduction velocity across the wrist and/or reduced amplitudes of the median nerve and normal ulnar nerve at the wrist.

Secondary Outcome Measures

Name	Time	Method
Severity of hand symptoms and hand dysfunction	10 min	QuickDash questionaire

Trial Locations

Locations (1)

Department of cardiology, Aarhus University Hospital in Skejby; 🇩🇰 Aarhus, Denmark