Prevalence of wtATTR-CM After Carpal Tunnel Release Surgery

Not Applicable

Recruiting

• Conditions: Transthyretin Cardiac Amyloidosis; Wild-Type Transthyretin-Related (ATTR)Amyloidosis; Transthyretin Amyloidosis
• Interventions: Diagnostic Test: Tenosynovial biopsy

• Registration Number: NCT04276220
• Lead Sponsor: Steen Hvitfeldt Poulsen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-18
• Study First Submitted QC: 2020-02-18
• Study First Posted: 2020-02-19
• Study Start: 2020-04-01
• Status Verified: 2024-01
• Last Update Submitted: 2024-02-05
• Last Update Posted: 2024-02-08
• Primary Completion: 2026-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tenosynovial Biopsy	Tenosynovial biopsy	-

Primary Outcome Measures

Name	Time	Method
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.	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 Outcome Measures

Name	Time	Method
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.	Compare NAC-stage, NYHA-class, LVEF ect.
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.	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.

Trial Locations

Locations (1)

Aarhus University Hospital; 🇩🇰 Aarhus, Jylland, Denmark