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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05365282

Acronym

ACCESS-IV

Enrollment

400

Registered

2022-05-09

Start date

2024-01-01

Completion date

2028-12-01

Last updated

2026-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carpal Tunnel Syndrome, Ischemic Heart Disease, Nerve Injury

Keywords

Transradial access, Ischemic Heart Disease, Hand Dysfunction

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Inclusion criteria

* The patient must be able to give informed consent

Exclusion criteria

* Pregnancy * Negative Barbeau test

Design outcomes

Primary

Measure	Time frame	Description
Neurophysiological measurements	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

Measure	Time frame	Description
Severity of hand symptoms and hand dysfunction	10min	Boston questionaire

Countries

Denmark

Contacts

CONTACTChristel G Aagren Nielsen

chisnils@rm.dk+45 78452213

CONTACTChristian J Terkelsen, Professor

Chriterk@rm.dk78452017

STUDY_CHAIRChristian J Terkelsen, Professor

Aarhus University Hospital

Outcome results