Transthyretin AmyloidosisPRATHYCNCT04611204
Transthyretin Cardiac Amyloidosis in Patients With Idiopathic Carpal Tunnel Syndrome Referred for Release Surgery
An observational study of Transthyretin Amyloidosis and Carpal Tunnel Syndrome, run by University Hospital, Toulouse at 1 site in France.
Trial summary
This study will determine the prevalence of transthyretin amyloidosis in pathology of the transverse carpal ligament and cardiac involvement using natriuretic peptides, electrocardiography and echocardiography in patients referred for carpal tunnel release surgery of idiopathic carpal tunnel syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transthyretin Amyloidosis, Carpal Tunnel Syndrome
- What is being tested?
- Descriptive cohort
- How many people
- 6 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2020to 23 Feb 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Interventional transversal monocentric study with prospective recruitment.
Who may be able to join
- Patients over 18 year-old
- Indication carpal tunnel release surgery of idiopathic carpal tunnel syndrome.
- To agree to participate (signature of the informed consent)
- Affiliate or beneficiary of a social security scheme
Who cannot join
- Patients with non-idiopathic carpal tunnel syndrome with medical contraindication : pregnancy, obesity (body mass index > 30), diabetes, rheumatoid arthritis, sarcoidosis, purulent tenosynovitis, tuberculosis, systemic lupus erythematosus, hypothyroidism or hyperthyroidism and gout.
- Patients with history of cardiac disease or coronary artery disease.
- Patients with systemic amyloidosis already known.
- Patients unde guardianship or curatorship
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence of Transthyretin Cardiac Amyloidosis in Patients With Idiopathic Carpal Tunnel Syndrome Referred for Release Surgery
This study will determine the prevalence of transthyretin amyloidosis in pathology of the transverse carpal ligament and cardiac involvement using natriuretic peptides, electrocardiography and echocardiography in patients referred for carpal tunnel release surgery of idiopathic carpal tunnel syndrome. This study will describe the relationship between amyloid deposition observed on the transverse carpal ligament and the presence of cardiac involvement.
Read the detailed description
Unrecognized wild-type transthyretin amyloidosis (ATTRwt) in patients with idiopathic carpal tunnel syndrome (CTS) is a prevalent aging-related disorder. Amyloid deposition in the tenosynovial tissue has been reported in ~35% of patients with idiopathic carpal tunnel syndrome.
Otherwise, CTS has been shown to be the most common initial symptom of systemic wild-type transthyretin amyloidosis. The clinical significance of subclinical ATTRwt deposits in the heart in elderly patients has yet to be determined, but these deposits could contribute to the development of heart failure with preserved ejection fraction. ATTRwt has been reported in ~15% of patients with heart failure with preserved ejection fraction. Early detection of amyloid deposition in the transverse carpal ligament of patients with CTS could anticipate cardiac damage and progression to heart failure.The aim of this study is to determine the prevalence of transthyretin amyloidosis in pathology of the transverse carpal ligament and cardiac involvement using natriuretic peptides, electrocardiography and echocardiography in patients referred for carpal tunnel release surgery of idiopathic carpal tunnel syndrome.
- Conditions
- Transthyretin Amyloidosis, Carpal Tunnel Syndrome
- Being tested
- Descriptive cohort
- Keywords
- cardiac amyloidosis, transthyretin amyloidosis, carpal tunnel syndrome
- Medical subject headings
- Amyloidosis, Hereditary, Transthyretin-Related, Carpal Tunnel Syndrome, Amyloid Neuropathies, Familial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Descriptive cohortOther
NT-proBNP assay, electrocardiogram and transthoracic echocardiography before CTS surgery release. Pathological analysis for amyloid deposits of transverse carpal ligament of patients included.
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac involvement
Prevalence of cardiac involvement in presence of transthyretin amyloid deposition in the transverse carpal ligament of patients with CTS referred for surgery released.
Measured: 1 day
Secondary outcomes (1)
Transthyretin amyloid involvement
Prevalence of transthyretin amyloid deposition in the transverse carpal ligament of patients with CTS referred for surgery released. Electrocardiographic features of cardiac involvement in case of presence of transthyretin amyloid deposition in the transverse carpal ligament of patients with CTS referred for surgery released.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2020
- Study start1 Oct 2020
- Primary completion23 Feb 2023
- Study completion23 Feb 2023
Why it stopped: insufficient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transthyretin AmyloidosisStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier LAIREZ, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04611204
- Sponsor's protocol ID
- RC31/18/0470
- Acronym
- PRATHYC
- Status last verified
- Feb 2024
- First submitted
- 26 Oct 2020
- Last updated
- 20 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Transthyretin Cardiac Amyloidosis in Patients With Idiopathic Carpal Tunnel Syndrome Referred for Release Surgery
- ClinicalTrials.gov ID
- NCT04611204
- Acronym / sponsor ID
- PRATHYC / RC31/18/0470
- Conditions
- Transthyretin Amyloidosis, Carpal Tunnel Syndrome
- Keywords
- cardiac amyloidosis, transthyretin amyloidosis, carpal tunnel syndrome
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: insufficient recruitment
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 23 Feb 2023 (actual)
- Study completion
- 23 Feb 2023 (actual)
- First posted
- 2 Nov 2020 (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.
This study will determine the prevalence of transthyretin amyloidosis in pathology of the transverse carpal ligament and cardiac involvement using natriuretic peptides, electrocardiography and echocardiography in patients referred for carpal tunnel release surgery of idiopathic carpal tunnel syndrome. This study will describe the relationship between amyloid deposition observed on the transverse carpal ligament and the presence of cardiac involvement.
Detailed description
Unrecognized wild-type transthyretin amyloidosis (ATTRwt) in patients with idiopathic carpal tunnel syndrome (CTS) is a prevalent aging-related disorder. Amyloid deposition in the tenosynovial tissue has been reported in ~35% of patients with idiopathic carpal tunnel syndrome.
Otherwise, CTS has been shown to be the most common initial symptom of systemic wild-type transthyretin amyloidosis. The clinical significance of subclinical ATTRwt deposits in the heart in elderly patients has yet to be determined, but these deposits could contribute to the development of heart failure with preserved ejection fraction. ATTRwt has been reported in ~15% of patients with heart failure with preserved ejection fraction. Early detection of amyloid deposition in the transverse carpal ligament of patients with CTS could anticipate cardiac damage and progression to heart failure.The aim of this study is to determine the prevalence of transthyretin amyloidosis in pathology of the transverse carpal ligament and cardiac involvement using natriuretic peptides, electrocardiography and echocardiography in patients referred for carpal tunnel release surgery of idiopathic carpal tunnel syndrome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Interventional transversal monocentric study with prospective recruitment.
Key inclusion criteria (4 listed)
- Patients over 18 year-old
- Indication carpal tunnel release surgery of idiopathic carpal tunnel syndrome.
- To agree to participate (signature of the informed consent)
- Affiliate or beneficiary of a social security scheme
Key exclusion criteria (4 listed)
- Patients with non-idiopathic carpal tunnel syndrome with medical contraindication : pregnancy, obesity (body mass index > 30), diabetes, rheumatoid arthritis, sarcoidosis, purulent tenosynovitis, tuberculosis, systemic lupus erythematosus, hypothyroidism or hyperthyroidism and gout.
- Patients with history of cardiac disease or coronary artery disease.
- Patients with systemic amyloidosis already known.
- Patients unde guardianship or curatorship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Descriptive cohortNT-proBNP assay, electrocardiogram and transthoracic echocardiography before CTS surgery release. Pathological analysis for amyloid deposits of transverse carpal ligament of patients included. | Other | – |
Primary outcome
Cardiac involvement
Time frame: 1 day
Prevalence of cardiac involvement in presence of transthyretin amyloid deposition in the transverse carpal ligament of patients with CTS referred for surgery released.
1 secondary outcome
Transthyretin amyloid involvement
Time frame: 1 day
Results and safety
The study was stopped early (reason given: insufficient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 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.
Olivier LAIREZ, MD principal investigator
University Hospital, Toulouse
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 Transthyretin Amyloidosis and Carpal Tunnel Syndrome, run by University Hospital, Toulouse 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 4 inclusion and 4 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: stopped early, as of the sponsor's last update on 20 Feb 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?
The study was stopped early (reason given: insufficient recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac involvement (time frame: 1 day). 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 20 Feb 2024.