← Back to Search

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up biopsy sent for testing immediately after the procedure

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I have or had atrial fibrillation/flutter.

Select...

I have symptoms of carpal tunnel in both hands or had surgery for it.

Select...

I have been diagnosed with congestive heart failure.

Select...

I have been diagnosed with spinal stenosis.

Select...

I am a man over 50 years old.

Select...

I have had a biceps tendon rupture in the past.

Select...

My family has a history of transthyretin amyloidosis.

Select...

I am a woman older than 60.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ biopsy sent for testing immediately after the procedure

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Rate of amyloid positivity

Trial Design

1Treatment groups

Experimental Treatment

Group I: Carpal Tunnel ReleaseExperimental Treatment1 Intervention

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

Henry Ford Health SystemLead Sponsor

300 Previous Clinical Trials

2,099,632 Total Patients Enrolled

Charles Day, MDPrincipal InvestigatorHenry Ford Health System

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this trial presently welcoming enrollees?

"Affirmative. Clinicaltrials.gov has data that indicates the current searching for participants in this clinical trial, which was first made known on August 3rd 2023 and updated lastly on 11/3/2023. The study is enrolling 250 patients from a single medical centre."

Answered by AI

How many subjects are participating in this medical experiment?

"Affirmative. Based on information provided by clinicaltrials.gov, this experiment is actively seeking out participants. It first went up for recruitment on August 3rd 2023 and was last revised November 3rd 2023; the study aims to enroll a total of 250 individuals at one location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Carpal Tunnel Release With Risk Factors for Amyloidosis

Charles S Day 2023. "Carpal Tunnel Release With Risk Factors for Amyloidosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05793320.

All > Carpal Tunnel > Amyloidosis