Carpal tunnel release surgery for patients at risk of amyloidosis
Prospective Histopathologic and Clinical Evaluation of Patients Undergoing Carpal Tunnel Release With Risk Markers for Amyloidosis
This study is testing if patients with carpal tunnel syndrome have signs of amyloidosis by taking tissue samples during surgery to see if they need further heart checks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | Henry Ford Health System Academic / other |
| Locations | 1 site (Detroit, Michigan) |
| Trial ID | NCT05793320 on ClinicalTrials.gov |
What this trial studies
This study investigates the relationship between bilateral carpal tunnel syndrome and amyloidosis by performing tissue biopsies during carpal tunnel release surgery. Patients with bilateral symptoms will be identified and undergo biopsy for congo red staining to check for amyloid presence. Those with positive biopsy results will be referred to cardiology for further evaluation of potential cardiac amyloidosis. The study aims to assess the rate of amyloid positivity and common subtypes, as well as echocardiographic findings post-referral.
Who should consider this trial
Good fit: Ideal candidates include males over 50 and females over 60 with bilateral carpal tunnel symptoms or a history of related surgeries.
Not a fit: Patients who have previously been diagnosed with cardiac amyloidosis will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier diagnosis and management of cardiac amyloidosis in patients with carpal tunnel syndrome.
How similar studies have performed: While previous studies have explored the connection between carpal tunnel syndrome and amyloidosis, this specific approach of early referral based on biopsy results is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Positive screening is defined as two characteristics from Tier 1 or one characteristic from Tier 1 and one from Tier 2 Tier 1 * Male \> 50 years old * Female \> 60 years old * Bilateral carpal tunnel symptoms or prior release surgery Tier 2 * Spinal stenosis * History of biceps tendon rupture * Atrial fibrillation or flutter (active or previous history) * Pacemaker * Congestive heart failure * Family history of transthyretin amyloidosis (ATTR) Exclusion Criteria: * Unable or unwilling to follow up with cardiology. * Previous diagnosis of cardiac amyloidosis.
Where this trial is running
Detroit, Michigan
- Henry Ford Main Campus — Detroit, Michigan, United States (Recruiting)
Study contacts
- Principal investigator: Charles Day, MD — Henry Ford Health System
- Study coordinator: Logan Hansen, MD
- Email: lhansen2@hfhs.org
- Phone: 313-916-2600
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.