ATTR Cardiac Amyloidosis in a Selected Population

Prevalence and Long Tem Follow Up of ATTR Cardiac Amyloidosis in a Selected Population of Patients Operated on Carpal Tunnel Syndrome

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.

Study Overview

• Status: Recruiting
• Conditions: Carpal Tunnel Syndrome; Cardiac Amyloidosis; ATTR Amyloidosis Wild Type; ATTR Gene Mutation

Detailed Description

Biopsy proven ATTR (v/wt) amyloidosis inpatients operated with CTS will undergo standard guidelines recommended examinations as 99mTcDPD SPECT CT, echocardiography, ECG, Holter, genetic testing (v/wt), and lab testing, and CMRI as indicated. Exclusion of light chain disease will be done.

All patients will be followed at least yearly as indicated by guidelines (ESC), and patients with development of cardiac amyloidosis will get standard treatment in accordance with guidelines and as approved by the Norwegian government. All patients will be followed for 10 years.

• Study Type: Observational
• Enrollment (Estimated): 180

Contacts and Locations

• Study Contact: Name: Torstein Hole, Professor, MD, PhD; Phone Number: +4770105000, +4793421002; Email: torstein.hole@helse-mr.no
• Study Contact Backup: Name: Jørn A Lillebø, consultant cardiology, MD; Phone Number: +4770105000; Email: jorn.asle.lillebo@helse-mr.no

Study Locations

• Norway
  • Møre og Romsdal
    • Ålesund, Møre og Romsdal, Norway, 6026
      • Recruiting
      • Ålesund Hospital
      • Contact: Torstein Hole, PhD; Phone Number: +4770105000; Email: torstein.hole@helse-mr.no
      • Contact: Jørn A Lillebø, MD; Phone Number: +4770105000; Email: jorn.asle.lillebo@helse-mr.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Maximum 200 patients operated at Ålesund Hospital for CTS

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Helse Møre og Romsdal HF
• Investigators: Principal Investigator: Torstein Hole, MD, PhD, Helse Møre og Romsdal HF and NTNU

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2024
• Primary Completion (Estimated): February 28, 2034
• Study Completion (Estimated): February 28, 2039

Study Registration Dates

• First Submitted: June 7, 2024
• First Submitted That Met QC Criteria: June 10, 2024
• First Posted (Actual): June 13, 2024

Study Record Updates

• Last Update Posted (Actual): October 16, 2024
• Last Update Submitted That Met QC Criteria: October 14, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Nervous System Diseases; Wounds and Injuries; Disease; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Proteostasis Deficiencies; Syndrome; Carpal Tunnel Syndrome; Amyloidosis
• Other Study ID Numbers: 715238

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No