Association Between Radial Artery Intervention and Development of Neuropathy in the Hand - A Prospective Study
ACCESS-IV
1 other identifier
observational
400
1 country
1
Brief Summary
Evaluation of potential nerve damage after radial CAG/PCI.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2024
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 4, 2022
CompletedFirst Posted
Study publicly available on registry
May 9, 2022
CompletedStudy Start
First participant enrolled
January 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2028
April 23, 2026
April 1, 2026
4.2 years
May 4, 2022
April 22, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Severity of hand symptoms and hand dysfunction
10min
Severity of hand symptoms and hand dysfunction
10 min
Study Arms (2)
Group A
Access pathway a. radialis (right or left) and neurophysiological measurements of the same hand (ipsilateral intervention group).
Group B
Access pathway a.radialis (right or left) and neurophysiological measurements of opposite hand (contralateral intervention group).
Eligibility Criteria
Patients suspected of ischemic heart disease scheduled for radial CAG/PCI at Aarhus University Hospital
You may qualify if:
- The patient must be able to give informed consent
You may not qualify if:
- Pregnancy
- Negative Barbeau test
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of cardiology, Aarhus University Hospital in Skejby
Aarhus, 8200, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Christian J Terkelsen, Professor
Aarhus University Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Professor, Chief Physician, PhD.
Study Record Dates
First Submitted
May 4, 2022
First Posted
May 9, 2022
Study Start
January 1, 2024
Primary Completion (Estimated)
March 1, 2028
Study Completion (Estimated)
December 1, 2028
Last Updated
April 23, 2026
Record last verified: 2026-04