Prevalence of wtATTR-CM After Carpal Tunnel Release Surgery (CACTuS2)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Transthyretin Amyloidosis; Transthyretin Cardiac Amyloidosis; Wild-Type Transthyretin-Related (ATTR)Amyloidosis
• Intervention / Treatment: Diagnostic test: Tenosynovial biopsy

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sie Kronborg Fensman; Phone Number: +45 30 48 88 85; Email: siefen@rm.dk

Study Locations

• Denmark
  • Jylland
    • Aarhus, Jylland, Denmark, 8200
      • Recruiting
      • Aarhus University Hospital
      • Contact: Steen Poulsen, DMSci; Email: steepoul@rm.dk
      • Contact: Bertil Ladefoged, MD; Email: berlad@rm.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Tenosynovial Biopsy	Diagnostic test: Tenosynovial biopsy; Tenosynovial biopsy taken from the wrist at the carpal tunnel release surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Levels of transthyretin in blood and urine from patients with suspected wild-type transthyretin cardiac amyloidosis	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.	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.	Compare NAC-stage, NYHA-class, LVEF ect.	Through study completion, 6 years.

Collaborators and Investigators

• Sponsor: Steen Hvitfeldt Poulsen

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2020
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: February 18, 2020
• First Submitted That Met QC Criteria: February 18, 2020
• First Posted (Actual): February 19, 2020

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Proteostasis Deficiencies; Amyloidosis
• Other Study ID Numbers: 1-10-72-178-19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No