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

Study Overview
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Brief Summary
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Evaluation of potential nerve damage after radial CAG/PCI.

Detailed Description
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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.

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

Conditions
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Nerve Injury, Ischemic Heart Disease, Carpal Tunnel Syndrome

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient must be able to give informed consent Exclusion Criteria: Pregnancy Negative Barbeau test

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group A<br>Access pathway a. radialis (right or left) and neurophysiological measurements of the same hand (ipsilateral intervention group). | |
| Group B<br>Access pathway a.radialis (right or left) and neurophysiological measurements of opposite hand (contralateral intervention group). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurophysiological measurements | 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 | Boston questionaire | 10min | 
| Severity of hand symptoms and hand dysfunction | QuickDash questionaire | 10 min | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transradial access, Ischemic Heart Disease, Hand Dysfunction