Skip to main content
OpenTrials
Completed

NCT Number: NCT04276220

Prevalence of wtATTR-CM After Carpal Tunnel Release Surgery

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus University Hospital

Aarhus, Jylland, 8200, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tenosynovial biopsy

Diagnostic Test

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

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.

    Time frame: Through study completion, 6 years.

    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

Secondary outcomes

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

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

    We will investigate the plasma and urine levels of different forms of TTR (total TTR, misTTR, and fragTTR) in patients with amyloid deposits in the transverse carpal ligament, patients subsequently diagnosed with ATTRwt-CM and in patients with already diagnosed ATTRwt matched age and gender.

    We will investigate whether the levels of TTR is higher among ligament amyloid positive patients that are subsequently diagnosed ATTRwt-CM as compared to those without ATTR-CM.

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

    Time frame: Through study completion, 6 years.

    Compare NAC-stage, NYHA-class, LVEF ect.

Sponsors and collaborators

Lead sponsor

Steen Hvitfeldt Poulsen

Other

Registry information

Official study title

Prevalence of Wild-Type Transthyretin Cardiac Amyloidosis Among Patients Undergoing Carpal Tunnel Release Surgery - A Prospective Study

Acronym: CACTuS2

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Feb 19, 2020
Registry last updated
Aug 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.