Prevalence of wtATTR-CM After Carpal Tunnel Release Surgery

NCT ID: NCT04276220

Last Updated: 2025-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

109 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-01

Study Completion Date

2025-05-21

Brief Summary

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Patients above the age of 60 will be recruited at their carpal tunnel release surgery. Biopsies will be taken from the wrist and examined for the presence of amyloid protein. A amyloid-positive biopsy will refer the patients for cardiac examination including blod- and urine samples examined for transthyretin.

If the result of the cardiac examination is suspected cardiac amyloidosis, the patient will be referred for a diagnostic TC99-DPD scintigraphy. If the scintigraphy is positive, the patient will be referred for right heart catherization (RHC) and an exercise test.

Myocardial biopsies will be taken at the RHC and examined with electron microscopy and high resolution respirometry.

Detailed Description

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Conditions

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Transthyretin Amyloidosis Transthyretin Cardiac Amyloidosis Wild-Type Transthyretin-Related (ATTR)Amyloidosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Tenosynovial Biopsy

Group Type OTHER

Tenosynovial biopsy

Intervention Type DIAGNOSTIC_TEST

Tenosynovial biopsy taken from the wrist at the carpal tunnel release surgery.

Interventions

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Tenosynovial biopsy

Tenosynovial biopsy taken from the wrist at the carpal tunnel release surgery.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Steen Hvitfeldt Poulsen

OTHER

Sponsor Role lead

Responsible Party

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Steen Hvitfeldt Poulsen

Professor, DMSc

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Aarhus University Hospital

Aarhus, Jylland, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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1-10-72-178-19

Identifier Type: -

Identifier Source: org_study_id

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