Prevalence of wtATTR-CM After Carpal Tunnel Release Surgery

NCT04276220 | Completed DMC

• 1 other identifier: 1-10-72-178-19
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Prevalence of wild-type transthyretin cardiac amyloidosis in patients undergoing surgery for idiopathic Carpal Tunnel Syndrome Surgery where biopsies from transverse carpal ligament stain positive for amyloid.

  We will examine the amyloid deposits prevalence in biopsies from the Carpal Tunnel and ATTRwt prevalence in an aged and predominantly male population operated for idiopathic Carpal Tunnel Syndrom. Diagnosis of wild-type cardiac amyloidosis will be determined by TC99-DPD scintigraphy, endomyocardial biopsy, or both. Biopsies will be examined using Congo Red staining and fluorescent light

  Through study completion, 6 years.

Secondary Outcomes (2)

• Levels of transthyretin in blood and urine from patients with suspected wild-type transthyretin cardiac amyloidosis

  Has been added after study start, will run through study completion, 3 years.

• Comparing patients diagnosed with wild-type transthyretin cardiac amyloidosis due to screening with age and gender matched clinically diagnosed ATTRwt patients.

  Through study completion, 6 years.

Study Arms (1)

Tenosynovial Biopsy

OTHER

Diagnostic Test: Tenosynovial biopsy

Interventions

Tenosynovial biopsy DIAGNOSTIC_TEST

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

Tenosynovial Biopsy

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Males above 65 years of age, females above 75 years of age.
• Scheduled idiopathic carpal tunnel release surgery.
• Informed written consent.

You may not qualify if:

• Operation by other indication, e.g.
• Fracture
• Ganglion
• Known amyloidosis

Sponsors & Collaborators

• Steen Hvitfeldt Poulsen: lead

Study Sites (1)

Aarhus University Hospital

Aarhus, Jylland, 8200, Denmark

Location

MeSH Terms

Conditions

Amyloidosis, Hereditary, Transthyretin-Related

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, DMSc

Study Record Dates

• First Submitted: February 18, 2020
• First Posted: February 19, 2020
• Study Start: April 1, 2020
• Primary Completion: May 21, 2025
• Study Completion: May 21, 2025
• Last Updated: August 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)