CompletedNot Applicable

Hereditary Transthyretin Amyloidosis Polyneuropathy in Patients With Carpal Tunnel Syndrome in Russia

Russia721 participantsStarted 2023-12-29

Plain-language summary

This is a multicenter observational study consisting of retrospective and prospective phases. The retrospective phase will entail secondary data collection from electronic or paper medical records of patients who underwent surgery for CTS to assess their probability of having ATTR PN.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Patients with the established diagnosis of CTS.
✓. Bilateral involvement of carpal tunnel established between the 1st January 2021 and the 31st December 2024 (both patients who underwent CTS surgical intervention and without it are enrolled).
✓. Age ≥ 18 years at the time of CTS diagnosis.
✓. Provided written informed consent for the prospective phase of the study (including molecular genetic testing).
✓. Presence of ≥1 of the following features (red flags):
✓. Absence of previously established ATTR PN diagnosis (ICD-10 code Е85.1, "Neuropathic hereditary familial amyloidosis").

Exclusion criteria

✕. Participation in any interventional trial within the period since identification of bilateral involvement of carpal tunnel until the end of current study.
✕. Previously performed TTR genetic testing;
✕. Verified B12 deficiency;
✕. History of alcohol abuse according to the patient's medical record.

What they're measuring

To define the prevalence of ATTR PN in patients diagnosed with CTS and having bilateral involvement in routine clinical practice in the Russian Federation.

Timeframe: Up to 12 months

Trial details

NCT IDNCT06414746

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-06-12

View on ClinicalTrials.gov More Hereditary Transthyretin Amyloidosis trials