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

Carpal Tunnel Syndrome Clinical Trial

— ACCESS-IV  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05365282
• Other study ID #: 1-10-72-177-20
• Status: Recruiting
• Start date: March 18, 2024
• Est. completion date: December 1, 2026

Study information

• Verified date: March 2024
• Source: Aarhus University Hospital Skejby
• Contact: Christel G Aagren Nielsen
• Phone: +45 78452213
• Email: chisnils[@]rm.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Evaluation of potential nerve damage after radial CAG/PCI.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 1, 2026
• Est. primary completion date: March 1, 2026
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• The patient must be able to give informed consent

Exclusion Criteria:

• Pregnancy

• Negative Barbeau test

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Coronary Artery Disease
• Heart Diseases
• Ischemic Heart Disease
• Myocardial Ischemia
• Nerve Injury

Locations

Country	Name	City	State
Denmark	Department of cardiology, Aarhus University Hospital in Skejby	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
Aarhus University Hospital Skejby

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Severity of hand symptoms and hand dysfunction	Boston questionaire	10min
Secondary	Severity of hand symptoms and hand dysfunction	QuickDash questionaire	10 min