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

Not Applicable

Completed

• Conditions: Amyloidosis Cardiac; Carpal Tunnel Syndrome
• Interventions: Diagnostic Test: DPD Scintigraphy

• Registration Number: NCT03996382
• Lead Sponsor: Aarhus University Hospital Skejby

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-17
• Study First Submitted: 2019-06-17
• Study First Submitted QC: 2019-06-21
• Study First Posted: 2019-06-24
• Primary Completion: 2020-12-01
• Study Completion: 2020-12-01
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-01
• Last Update Posted: 2021-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Suspicion of cardiac amyloidosis	DPD Scintigraphy	Patients who display signs of cardiac amyloidosis will be referred for further diagnosis.

Primary Outcome Measures

Name	Time	Method
Prevalence of cardiac amyloidosis.	Through study completion, an average of 2 years.	The prevalence of cardiac amyloidosis among patients previously operated for ipiopathic carpal tunnel syndrome.

Trial Locations

Locations (1)

Department of Heart Disease; 🇩🇰 Aarhus, Denmark