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

Aarhus University Hospital Skejby

Status: Enrolling

Conditions: Ischemic Heart Disease; Carpal Tunnel Syndrome; Nerve Injury

Study type: Observational

Funder types: Other

Identifiers

NCT05365282

1-10-72-177-20

Details and patient eligibility

About

Evaluation of potential nerve damage after radial CAG/PCI.

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The patient must be able to give informed consent

Exclusion criteria

• Pregnancy
• Negative Barbeau test

Trial design

400 participants in 2 patient groups

Group A

Description:

Access pathway a. radialis (right or left) and neurophysiological measurements of the same hand (ipsilateral intervention group).

Group B

Description:

Access pathway a.radialis (right or left) and neurophysiological measurements of opposite hand (contralateral intervention group).