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Prevalence of wtATTR-CM After Carpal Tunnel Release Surgery

NCT04276220 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 109

Last updated 2025-08-15

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

Tenosynovial biopsy

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

Sponsors & Collaborators

  • Steen Hvitfeldt Poulsen

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-01
Primary Completion
2025-05-21
Completion
2025-05-21

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04276220 on ClinicalTrials.gov