Evaluating nerve damage risk after radial artery procedures
Association Between Radial Artery Intervention and Development of Neuropathy in the Hand - A Prospective Study - The ACCESS IV Study
This study is testing if patients who have procedures on their radial artery for heart disease experience nerve damage by checking their nerve function before and after the procedure.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Aarhus University Hospital Skejby Academic / other |
| Locations | 1 site (Aarhus) |
| Trial ID | NCT05365282 on ClinicalTrials.gov |
What this trial studies
This study evaluates the potential for nerve damage in patients undergoing radial artery interventions for ischemic heart disease. Patients scheduled for radial coronary angiography or percutaneous coronary intervention will undergo sensory and motor nerve examinations before and one month after the procedure. Each patient serves as their own control, allowing for a direct comparison of nerve function. Additionally, patients will complete questionnaires regarding hand and arm symptoms and perform specific activities to assess functional impact.
Who should consider this trial
Good fit: Ideal candidates are patients scheduled for radial coronary angiography or PCI who can provide informed consent.
Not a fit: Patients who are pregnant or have a negative Barbeau test will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify risks associated with radial artery access, leading to improved patient safety and outcomes.
How similar studies have performed: While this study explores a specific association, similar observational studies have indicated potential risks with radial access, suggesting that this area warrants further investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * The patient must be able to give informed consent Exclusion Criteria: * Pregnancy * Negative Barbeau test
Where this trial is running
Aarhus
- Department of cardiology, Aarhus University Hospital in Skejby — Aarhus, Denmark (Recruiting)
Study contacts
- Study coordinator: Christel G Aagren Nielsen
- Email: chisnils@rm.dk
- Phone: +45 78452213
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.