Orthopaedic Specimen Pathology and Early Diagnosis of ATT... | NCT06367842

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

NCT06367842

Sponsor

Institut Mutualiste Montsouris

Status

Unknown status

Last Update Posted

Apr 16, 2024Actual

Enrollment

150Estimated

Phase

Not provided

Conditions

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

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 27, 2024Actual

Primary Completion Date

Apr 2025Estimated

Completion Date

Sep 2025Estimated

First Submitted Date

Mar 6, 2024

First Submission Date that Met QC Criteria

Apr 10, 2024

First Posted Date

Apr 16, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 10, 2024

Last Update Posted Date

Apr 16, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

What is the frequency of ATTR deposits in samples retrieved during surgery?
What is the frequency of cardiac involvement in ATTR positive patients?
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

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
frequency of ATTR amyloidosis	presence of ATTR amyloidosis in surgical samples by immunohistochemistry performed when samples countain amyloi by Congo red.ATTR will be semiquantitalively assessed using a published scale.	18 months

Secondary Outcomes

Measure	Description	Time Frame
presence of ATTR cardiopathy	Diagnosis by multimodal imaging(bone scintigraphy, cardiac US scan, MRI)	20 months
proportion of wild type and hereditary ATTR	hereditary: patients exibit a mutation of the TTR gene, wild type: no mutation. TTR genotyping will determine if the gene is muted (hereditary ATTR) or not (wild type).

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients aged 50 or over
having signed an informed consent form
undergoing surgery for
1. idiopathic carpal tunnel syndrome
2. or lumbar spinal canal stenosis
3. or prosthetic replacement of a hip or knee for primary osteoarthritis

Exclusion Criteria:

secondary carpal tunnel syndrome (inflammatory rheumatism, diabetes, hypothyroidism, etc.)
Indication of prosthesis for a condition other than primary osteoarthritis.
Known amyloidosis
Refusal of consent
Inability to understand the study
Age < 50 years

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients meeting the inclusion criteria in a single orthopaedic surgery center located in Paris, France

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mutualist Montsouris Institute	Recruiting	Paris		75014	France

Condition Browse Module

MeSH Terms

ID	Term
D006331	Heart Diseases
D002349	Carpal Tunnel Syndrome
D028227	Amyloid Neuropathies, Familial

Ancestor Terms

ID	Term
D002318	Cardiovascular Diseases
D020423	Median Neuropathy
D020422	Mononeuropathies
D010523	Peripheral Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided