Association Between Radial Artery Intervention and Development of Neuropathy in the Hand - A Prospective Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Ischemic Heart Disease, Nerve Injury, Carpal Tunnel Syndrome. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Association Between Radial Artery Intervention and Development of Neuropathy in the Hand - A Prospective Study - The ACCESS IV Study
Overview
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.
Primary outcome measures
- Neurophysiological measurements [Time frame: Aprox 1 hour]
Secondary outcome measures (2)
- Severity of hand symptoms and hand dysfunction [Time frame: 10min]
- Severity of hand symptoms and hand dysfunction [Time frame: 10 min]
Eligibility criteria
Inclusion criteria
- The patient must be able to give informed consent
Exclusion criteria
- Pregnancy
- Negative Barbeau test
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Denmark · 1 center
- Department of cardiology, Aarhus University Hospital in Skejby — Aarhus
Identifiers
NCT: NCT05365282 · 1-10-72-177-20