Prevalence of wtATTR-CM After Carpal Tunnel Release Surgery

Steen Hvitfeldt Poulsen109 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

109

Conditions

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

Outcomes

Primary Outcomes

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

Time frame: Through study completion, 6 years.

Secondary Outcomes

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.

Time frame: 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.