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NCT Number: NCT05365282

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

Evaluation of potential nerve damage after radial CAG/PCI.

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Key information

Conditions

Ischemic Heart Disease Cardiovascular Diseases Carpal Tunnel Syndrome Cumulative Trauma Disorders Heart Diseases Median Neuropathy Mononeuropathies Myocardial Ischemia Nerve Compression Syndromes Nerve Injury Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Sprains and Strains Vascular Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of cardiology, Aarhus University Hospital in Skejby

Aarhus, 8200, Denmark

Location status: Recruiting

Location contact

Christian J Terkelsen, MD,PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The patient must be able to give informed consent

Exclusion criteria

  • Pregnancy
  • Negative Barbeau test

Treatment and study plan

Primary outcomes

  1. 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

  1. Severity of hand symptoms and hand dysfunction

    Time frame: 10min

    Boston questionaire

  2. Severity of hand symptoms and hand dysfunction

    Time frame: 10 min

    QuickDash questionaire

Study contacts

Contact information is provided by the study sponsor or research team.

Christel G Aagren Nielsen

CONTACT

[email protected]

+45 78452213

Christian J Terkelsen, Professor

CONTACT

[email protected]

78452017

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital Skejby

Other

Registry information

Official study title

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

Acronym: ACCESS-IV

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
May 9, 2022
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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