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Clinical Trials/NCT05365282
NCT05365282
Recruiting
Not Applicable

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

Aarhus University Hospital Skejby1 site in 1 country400 target enrollmentJanuary 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Ischemic Heart Disease
Sponsor
Aarhus University Hospital Skejby
Enrollment
400
Locations
1
Primary Endpoint
Neurophysiological measurements
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2024
End Date
December 1, 2026
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Aarhus University Hospital Skejby
Responsible Party
Principal Investigator
Principal Investigator

Christian Juhl Terkelsen

Professor, Professor, Chief Physician, PhD.

Aarhus University Hospital Skejby

Eligibility Criteria

Inclusion Criteria

  • The patient must be able to give informed consent

Exclusion Criteria

  • Pregnancy
  • Negative Barbeau test

Outcomes

Primary Outcomes

Neurophysiological measurements

Time Frame: 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 Outcomes

  • Severity of hand symptoms and hand dysfunction(10 min)

Study Sites (1)

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