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Orthopaedic Specimen Pathology and Early Diagnosis of ATTR Cardiopathy (ATTR-ORTHO)

NCT06367842 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2024-04-16

No results posted yet for this study

Summary

The goal of this observational study is to learn about the frequency of ATTR amyloid, cardiac involvement and associated features, in 150 patients aged 50 or more years, and operated for an idiopathic carpal tunnel syndrome, lumbar spine stenosis or total hip or knee arthroplasty for primary osteoarthritis. The main questions to be answered are:

1. What is the frequency of ATTR deposits in samples retrieved during surgery?
2. What is the frequency of cardiac involvement in ATTR positive patients?
3. What are the preoperative predictors of ATTR deposits? Participants will

* have operative samples stained by Congo red in search of amyloid, which will be typed by immunochemistry in positive samples,
* undergo a multimodal imaging search for cardiac involvement, if ATTR is identified,
* undergo a preoperative complete clinical examination, including collection of medical history, ECG, biochemical tests, and imaging (ultrasound scans of rotator cuff and hip capsule in all participating patients, of the carpal tunnel in patients operated at this site, and MRI + standing profile radiography of the lumbar spine, in patients operated for lumbar stenosis)
* ATTR positive patients will be proposed to be followed-up by a reference center, with the aim of an early diagnosis of cardiac involvement, allowing efficient mamagement.

Researchers will assess the frequency of ATTR deposits at each operated site, the frequency or ATTR cardiopathy in ATTR + patients, and will compare demographic, clinical, biochemical, and imaging features in patients with and without ATTR deposits, to guide the indications of pathological examination during these frequent orthopedic surgeries

Conditions

  • ATTR Amyloidosis
  • Cardiopathy
  • Carpal Tunnel Syndrome
  • Lumbar Spine Stenosis
  • Hip Prosthesis
  • Knee Prosthesis

Sponsors & Collaborators

  • Institut Mutualiste Montsouris

    lead OTHER

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-27
Primary Completion
2025-04-30
Completion
2025-09-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06367842 on ClinicalTrials.gov