Prevalence of Wild Type Transthyretin Cardiac Amyloidosis in Patients Operated for Idiopathic Carpal Tunnel Syndrome

Carpal Tunnel Syndrome Clinical Trial

— CACTuS  

Official title:

Prevalence of Wild Type Transthyretin Cardiac Amyloidosis in Patients Operated for Idiopathic Carpal Tunnel Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03996382
• Other study ID #: 1-10-72-330-18
• Status: Completed
• Phase: N/A
• Start date: June 17, 2019
• Est. completion date: December 1, 2020

Study information

• Verified date: October 2021
• Source: Aarhus University Hospital Skejby
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Wild-type transthyretin cardiac amyloidosis is an underdiagnosed depository disease in which fibril monomers of misfolded amyloid protein accumulates in various tissues, including the heart, and cause tissue dysfunction.

Before onset of cardiac symptoms, many patients will have undergone surgery for idiopathic carpal tunnel syndrome since the protein also deposits in the transversal carpal ligament of the hand.

This study investigates patients previously operated for idiopathic carpal tunnel syndrome to determine if they display signs and symptoms of cardiac amyloidosis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 1, 2020
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• Patients above sixty years of age previously operated for idiopathic carpal tunnel syndrome within the Region of Central Denmark (Region Midtjylland) the last five years.

• Informed written and verbal consent

Exclusion Criteria:

• Operation by different indication such as

• Fracture

• Ganglion

• Tumors

• Osteophytes

• Rheumatoid Arthritis

• Persistent medial artery

• Metabolic causes

• Alcoholism

• Hyperthyroidism

• Myxedema

• Hereditary Cardiac Amyloidosis

• Known WT ATTR

• AL Amyloidosis

• Myelomatosis

• MGUS and Morbus Waldenström

Related Conditions & MeSH terms

• Amyloidosis
• Amyloidosis Cardiac
• Carpal Tunnel Syndrome
• Syndrome

Intervention

Diagnostic Test:
• DPD Scintigraphy
Confirms/Refutes diagnosis of cardiac amyloidosis.

Locations

Country	Name	City	State
Denmark	Department of Heart Disease	Aarhus

Sponsors (2)

Lead Sponsor	Collaborator
Aarhus University Hospital Skejby	Regional Hospital Holstebro

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of cardiac amyloidosis.	The prevalence of cardiac amyloidosis among patients previously operated for ipiopathic carpal tunnel syndrome.	Through study completion, an average of 2 years.