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Procedure

Carpal Tunnel Release Surgery for Amyloidosis

N/A
Recruiting
Led By Charles Day, MD
Research Sponsored by Henry Ford Health System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Atrial fibrillation or flutter (active or previous history)
Bilateral carpal tunnel symptoms or prior release surgery
Must not have
Previous diagnosis of cardiac amyloidosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up biopsy sent for testing immediately after the procedure
Awards & highlights
No Placebo-Only Group

Summary

This trial will analyze if carpal tunnel patients with amyloid-positive biopsies will benefit from an early referral to cardiology.

Who is the study for?
This trial is for people over 50 (men) or 60 (women) with bilateral carpal tunnel symptoms, a family history of ATTR, heart issues like congestive heart failure or atrial fibrillation, spinal stenosis, pacemaker, or biceps tendon rupture. They must not have been previously diagnosed with cardiac amyloidosis and be willing to follow up with cardiology.
What is being tested?
The study tests if patients undergoing carpal tunnel release surgery who are found to have amyloid deposits benefit from early cardiology referral for potential cardiac amyloidosis. It involves biopsy during surgery and subsequent echocardiographic monitoring after referral.
What are the potential side effects?
Potential side effects include those associated with any surgical procedure such as pain at the incision site, infection risk, nerve damage near the operated area, and complications related to anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have or had atrial fibrillation/flutter.
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I have symptoms of carpal tunnel in both hands or had surgery for it.
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I have been diagnosed with congestive heart failure.
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I have been diagnosed with spinal stenosis.
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I am a man over 50 years old.
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I have had a biceps tendon rupture in the past.
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My family has a history of transthyretin amyloidosis.
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I am a woman older than 60.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with cardiac amyloidosis before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~biopsy sent for testing immediately after the procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and biopsy sent for testing immediately after the procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Rate of amyloid positivity

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Carpal Tunnel ReleaseExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Henry Ford Health SystemLead Sponsor
311 Previous Clinical Trials
2,176,146 Total Patients Enrolled
Charles Day, MDPrincipal InvestigatorHenry Ford Health System
~107 spots leftby Dec 2025
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