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

April 22, 2026 updated by: Christian Juhl Terkelsen, Aarhus University Hospital Skejby

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

Evaluation of potential nerve damage after radial CAG/PCI.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Christel G Aagren Nielsen
  • Phone Number: +45 78452213
  • Email: chisnils@rm.dk

Study Contact Backup

  • Name: Christian J Terkelsen, Professor
  • Phone Number: 78452017
  • Email: Chriterk@rm.dk

Study Locations

  • Denmark
      • Aarhus, Denmark, 8200
        • Recruiting
        • Department of cardiology, Aarhus University Hospital in Skejby
        • Principal Investigator:
          • Christian J Terkelsen, MD,PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Patients suspected of ischemic heart disease scheduled for radial CAG/PCI at Aarhus University Hospital

Description

Inclusion Criteria:

  • The patient must be able to give informed consent

Exclusion Criteria:

  • Pregnancy
  • Negative Barbeau test

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Group A
Access pathway a. radialis (right or left) and neurophysiological measurements of the same hand (ipsilateral intervention group).
Group B
Access pathway a.radialis (right or left) and neurophysiological measurements of opposite hand (contralateral intervention group).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Aprox 1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity of hand symptoms and hand dysfunction
Time Frame: 10min
Boston questionaire
10min
Severity of hand symptoms and hand dysfunction
Time Frame: 10 min
QuickDash questionaire
10 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aarhus University Hospital Skejby

Investigators

  • Study Chair: Christian J Terkelsen, Professor, Aarhus University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

May 4, 2022

First Submitted That Met QC Criteria

May 4, 2022

First Posted (Actual)

May 9, 2022

Study Record Updates

Last Update Posted (Actual)

April 23, 2026

Last Update Submitted That Met QC Criteria

April 22, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-10-72-177-20

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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