Actively Recruiting
Prevalence and Long Term Follow Up of ATTR Cardiac Amyloidosis in Patients Operated on for Carpal Tunnel Syndrome
Led by Helse Møre og Romsdal HF · Updated on 2024-10-16
180
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the prevalence and long-term follow-up of ATTR amyloidosis among patients who have undergone surgery for carpal tunnel syndrome (CTS) at Ålesund Hospital. The study focuses on patients who have biopsy-proven ATTR amyloidosis, including both wild type and gene mutation forms. It aims to assess cardiac involvement in this selected population and monitor disease progression over time. Patients with confirmed ATTR amyloidosis through biopsy will receive examinations following standard guidelines, including 99mTcDPD SPECT CT scans, echocardiography, ECG, Holter monitoring, genetic testing, and laboratory tests. Cardiac magnetic resonance imaging (CMRI) will be performed when indicated. Light chain disease will be excluded. All patients will be followed yearly according to ESC guidelines, and those who develop cardiac amyloidosis will receive standard treatments approved by the Norwegian government. Participants will be monitored for up to 10 years with regular clinical evaluations and echocardiography to track cardiac involvement and disease status. The study's main outcomes include the frequency of ATTR amyloidosis in CTS patients over 2 years and cardiac involvement in biopsy-proven ATTR patients over 10 years. This long-term observation aims to provide valuable information on disease progression and management.
CONDITIONS
Brief Title
ATTR Cardiac Amyloidosis in a Selected Population
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male participants over 50 years old
- Female participants over 60 years old
- Have undergone carpal tunnel syndrome surgery at Ålesund Hospital
You will not qualify if you...
- Have not given consent to participate
- Do not speak Norwegian
- Carpal tunnel syndrome caused by trauma or rheumatic conditions
- Unable to be followed for more than 5 years due to other medical conditions
- Have cardiac disease at the time of carpal tunnel surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years
Participants undergo examinations including 99mTcDPD SPECT CT, echocardiography, ECG, Holter monitoring, genetic and lab testing, and CMRI as indicated to assess for ATTR cardiac amyloidosis.
1 to 2 visits depending on testing requirements
Duration - Up to 10 years
Participants are followed yearly according to guidelines to monitor cardiac status and progression of ATTR amyloidosis. Those who develop cardiac amyloidosis receive standard treatment as per guidelines.
Annual visits for up to 10 years
Trial Site Locations
Total: 1 location
1
Ålesund Hospital
Ålesund, Møre og Romsdal, Norway, 6026
Actively Recruiting
Research Team
T
Torstein Hole, Professor, MD, PhD
J
Jørn A Lillebø, consultant cardiology, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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