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

NCT03996382 | Completed

• 1 other identifier: 1-10-72-330-18
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Amyloidosis Cardiac; Carpal Tunnel Syndrome

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

Suspicion of cardiac amyloidosis

OTHER

Patients who display signs of cardiac amyloidosis will be referred for further diagnosis.

Diagnostic Test: DPD Scintigraphy

Interventions

DPD Scintigraphy DIAGNOSTIC_TEST

Confirms/Refutes diagnosis of cardiac amyloidosis.

Suspicion of cardiac amyloidosis

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aarhus University Hospital Skejby: lead
• Regional Hospital Holstebro: collaborator

Study Sites (1)

Department of Heart Disease

Aarhus, 8200, Denmark

Location

MeSH Terms

Conditions

Amyloid Neuropathies, Familial; Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Nervous System Diseases; Amyloid Neuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Amyloidosis, Familial; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases; Amyloidosis; Proteostasis Deficiencies; Median Neuropathy; Mononeuropathies; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 17, 2019
• First Posted: June 24, 2019
• Study Start: June 17, 2019
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: October 8, 2021

Record last verified: 2021-10

Locations

DK (1)