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

Steen Hvitfeldt Poulsen

Status: Completed

Conditions: Transthyretin Amyloidosis; Transthyretin Cardiac Amyloidosis; Wild-Type Transthyretin-Related (ATTR)Amyloidosis

Treatments: Diagnostic Test: Tenosynovial biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT04276220

1-10-72-178-19

Details and patient eligibility

About

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.

Enrollment: 109 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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109 participants in 1 patient group

Tenosynovial Biopsy

Other group

Treatment:

Diagnostic Test: Tenosynovial biopsy