ATTR Cardiac Amyloidosis in a Selected Population

NCT06458374 | Recruiting

• 1 other identifier: 715238
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

Patients operated for carpal tunnel syndrome (CTS) at Ålesund Hospital (200 patients) will have a biopsy to diagnose ATTR amyloidosis. Patients with positive biopsy will be examined to decide wether they have cardiac amyloidosis. All patients with positive biopsy will be followed closely for 10 years wit echocardiography an clinically.

Conditions

ATTR Amyloidosis Wild Type; ATTR Gene Mutation; Carpal Tunnel Syndrome; Cardiac Amyloidosis

Outcome Measures

Primary Outcomes (2)

• Frequency of ATTR in CTS

  Biopsy proven ATTR

  2 years

• Cardiac involvement in patients with biopsy proven ATTR

  Scintigraphic and echocardiographic cardiac involvement possibly cMRI

  10 years

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Maximum 200 patients operated at Ålesund Hospital for CTS

You may qualify if:

• Male \> 50 years
• Female \> 60 years
• operated CTS at Ålesund Hospital

You may not qualify if:

• not consented
• do not speak Norwegian
• secondary cause of CTS as traumatic or rheumatic
• cannot be followed \> 5 years due to other medical conditions
• Cardiac disease at time of operation for CTS

Sponsors & Collaborators

• Helse Møre og Romsdal HF: lead

Study Sites (1)

Ålesund Hospital

Ålesund, Møre og Romsdal, 6026, Norway

RECRUITING

MeSH Terms

Conditions

Carpal Tunnel Syndrome; Amyloid Neuropathies, Familial

Condition Hierarchy (Ancestors)

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

Study Officials

• Torstein Hole, MD, PhD

  Helse Møre og Romsdal HF and NTNU

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Torstein Hole, Professor, MD, PhD

CONTACT

+4770105000, +4793421002; torstein.hole@helse-mr.no

Jørn A Lillebø, consultant cardiology, MD

CONTACT

+4770105000; jorn.asle.lillebo@helse-mr.no

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2024
• First Posted: June 13, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): February 28, 2034
• Study Completion (Estimated): February 28, 2039
• Last Updated: October 16, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)