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

NCT ID: NCT05365282

Last Updated: 2025-01-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-01

Study Completion Date

2026-12-01

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.

Conditions

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Ischemic Heart Disease Nerve Injury Carpal Tunnel Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group A

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

No interventions assigned to this group

Group B

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

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* The patient must be able to give informed consent

Exclusion Criteria

* Pregnancy
* Negative Barbeau test
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aarhus University Hospital Skejby

OTHER

Sponsor Role lead

Responsible Party

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Christian Juhl Terkelsen

Professor, Professor, Chief Physician, PhD.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christian J Terkelsen, Professor

Role: STUDY_CHAIR

Aarhus University Hospital

Locations

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Department of cardiology, Aarhus University Hospital in Skejby

Aarhus, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Christel G Aagren Nielsen

Role: CONTACT

+45 78452213

Christian J Terkelsen, Professor

Role: CONTACT

Other Identifiers

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1-10-72-177-20

Identifier Type: -

Identifier Source: org_study_id

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