ATTR AmyloidosisATTR-ORTHONCT06367842
Orthopaedic Specimen Pathology and Early Diagnosis of ATTR Cardiopathy (ATTR-ORTHO)
An observational study of ATTR Amyloidosis and Cardiopathy, run by Institut Mutualiste Montsouris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- ATTR Amyloidosis, Cardiopathy, Carpal Tunnel Syndrome
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 27 Feb 2024to Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients meeting the inclusion criteria in a single orthopaedic surgery center located in Paris, France
Who may be able to join
- patients aged 50 or over
- having signed an informed consent form
- undergoing surgery for
- idiopathic carpal tunnel syndrome
- or lumbar spinal canal stenosis
- or prosthetic replacement of a hip or knee for primary osteoarthritis
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Mutualist Montsouris Institute
Paris, 75014
Thomas M Bardin, Pr, +33 156616263, thomas.bardin@imm.fr
About this study
Official title: Contribution of Systematic Pathological Examination of Orthopaedic Specimens to the Early Diagnosis of Tranthyretin Amyloid Heart Disease
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
Read more
- 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
- Keywords
- ATTR amyloidosis, cardiac amyloidosis, orthopaedic surgery
- Medical subject headings
- Heart Diseases, Carpal Tunnel Syndrome, Amyloid Neuropathies, Familial
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 months
Secondary outcomes (5)
presence of ATTR cardiopathy
Diagnosis by multimodal imaging(bone scintigraphy, cardiac US scan, MRI)
Measured: 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).
Measured: 20 months
Description of preoperative predictors of ATTR
features more frequent in patients diagnosed with ATTR versus not:
- demographic and clinical characteristics, will be collected before surgery and compared in ATTR positive and ATTR negative patients.
Measured: 18 months
Description of preoperative predictors of ATTR
features more frequent in patients diagnosed with ATTR versus not:
- imaging characteristics (USscans of rotator cuff, hip capsula and carpal tunel) will be collected before surgery and compared in ATTR positive and ATTR negative patients.
Measured: 18 months
preoperative predictors of ATTR
biochemical features more frequent in patients diagnosed with ATTR versus not:
- troponine (g/L)
- BNP (ng/L)
- proteuniria (ng/L) will be collected before surgery and compared in ATTR positive and ATTR negative patients.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start27 Feb 2024
- Primary completionApr 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ATTR AmyloidosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Mutualiste Montsouris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06367842
- Sponsor's protocol ID
- MED-02-2023
- Acronym
- ATTR-ORTHO
- Status last verified
- Apr 2024
- First submitted
- 6 Mar 2024
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of Systematic Pathological Examination of Orthopaedic Specimens to the Early Diagnosis of Tranthyretin Amyloid Heart Disease
- ClinicalTrials.gov ID
- NCT06367842
- Acronym / sponsor ID
- ATTR-ORTHO / MED-02-2023
- Conditions
- ATTR Amyloidosis, Cardiopathy, Carpal Tunnel Syndrome, Lumbar Spine Stenosis, Hip Prosthesis, Knee Prosthesis
- Keywords
- ATTR amyloidosis, cardiac amyloidosis, orthopaedic surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Institut Mutualiste MontsourisUniversity, hospital or other
- Study start
- 27 Feb 2024 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 16 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients meeting the inclusion criteria in a single orthopaedic surgery center located in Paris, France
Key inclusion criteria (6 listed)
- patients aged 50 or over
- having signed an informed consent form
- undergoing surgery for
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
frequency of ATTR amyloidosis
Time frame: 18 months
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.
5 secondary outcomes
presence of ATTR cardiopathy
Time frame: 20 months
proportion of wild type and hereditary ATTR
Time frame: 20 months
Description of preoperative predictors of ATTR
Time frame: 18 months
Description of preoperative predictors of ATTR
Time frame: 18 months
preoperative predictors of ATTR
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ATTR Amyloidosis and Cardiopathy, run by Institut Mutualiste Montsouris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
frequency of ATTR amyloidosis (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2024.