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A hidden warning in your wrist? surgery may reveal heart risk

NCT ID NCT05793320

Diagnosis Sponsor: Henry Ford Health System Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 14, 2026 · Last updated Aug 14, 2026

Summary

This study tests whether tissue taken during routine carpal tunnel release surgery can help diagnose amyloidosis, a condition where abnormal proteins build up in organs. People with bilateral carpal tunnel syndrome and certain risk factors—like age, heart issues, or family history—will have a biopsy during surgery. If the biopsy is positive, they'll be referred to a cardiologist for further heart evaluation. The goal is to see if carpal tunnel syndrome can serve as an early warning sign for amyloidosis.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Carpal tunnel release surgery with tissue biopsy
What this could lead to
If it works, this could lead to earlier detection of amyloidosis, allowing timely heart care and better outcomes.
What could go wrong
The study is exploratory and may not prove that biopsy findings reliably predict heart amyloidosis. Risks include surgical complications and false positives.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

250 people

The number who actually took part.

Started

Aug 2023

Finished

Dec 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

amyloidosis carpal tunnel syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Amyloidosis

Contacts and locations

Locations

  • Henry Ford Main Campus

    Detroit, Michigan, 48202, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.