Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06367842
Status:
RECRUITING
Last Update Posted:
2024-04-16
First Post:
2024-03-06
Brief Title:
Orthopaedic Specimen Pathology and Early Diagnosis of ATTR Cardiopathy ATTR-ORTHO
Sponsor:
Institut Mutualiste Montsouris
Organization:
Institut Mutualiste Montsouris
Study Overview
Official Title:
Contribution of Systematic Pathological Examination of Orthopaedic Specimens to the Early Diagnosis of Tranthyretin Amyloid Heart Disease
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ATTR-ORTHO
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None