Examining the prevalence of a specific type of amyloidosis in patients undergoing carpal tunnel surgery
Prevalence of Wild-Type Transthyretin Cardiac Amyloidosis Among Patients Undergoing Carpal Tunnel Release Surgery - A Prospective Study
This study is testing if older patients having carpal tunnel surgery have a specific type of amyloidosis by checking for amyloid proteins in their wrist during the operation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Aarhus University Hospital Skejby Academic / other |
| Locations | 1 site (Aarhus, Jylland) |
| Trial ID | NCT04276220 on ClinicalTrials.gov |
What this trial studies
This study recruits patients over the age of 60 who are scheduled for carpal tunnel release surgery. During the procedure, biopsies will be taken from the wrist to check for amyloid protein presence. If amyloid is detected, patients will undergo further cardiac examinations, including blood and urine tests for transthyretin, and potentially a diagnostic scintigraphy. If cardiac amyloidosis is suspected, additional tests such as right heart catheterization and myocardial biopsies will be performed to confirm the diagnosis.
Who should consider this trial
Good fit: Ideal candidates are males over 65 years and females over 75 years who are scheduled for idiopathic carpal tunnel release surgery.
Not a fit: Patients undergoing carpal tunnel surgery for reasons other than idiopathic conditions or those with known amyloidosis will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier diagnosis and better management of transthyretin amyloidosis in older patients.
How similar studies have performed: While there is limited information on similar studies, the approach of using surgical biopsies to identify underlying conditions has shown promise in related research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Males above 65 years of age, females above 75 years of age. * Scheduled idiopathic carpal tunnel release surgery. * Informed written consent. Exclusion Criteria: * Operation by other indication, e.g. * Fracture * Ganglion * Known amyloidosis
Where this trial is running
Aarhus, Jylland
- Aarhus University Hospital — Aarhus, Jylland, Denmark (Recruiting)
Study contacts
- Study coordinator: Sie Kronborg Fensman
- Email: siefen@rm.dk
- Phone: +45 30 48 88 85
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.