Transthyretin AmyloidosisCarPoSNCT05409833
Systemic Transthyretin Amyloidosis: Carpal Tunnel Syndrome in a Portuguese Population
An observational study of Transthyretin Amyloidosis and Carpal Tunnel Syndrome, run by Universidade do Porto at 2 sites in Portugal.
Trial summary
Systemic transthyretin amyloidosis is an aging-related disorder. It is usually associated with cardiac disease but also extends to other organs. Recent studies found that idiopathic carpal tunnel syndrome patients may have amyloid deposition in tenosynovial tissue. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Transthyretin Amyloidosis, Carpal Tunnel Syndrome
- What is being tested?
- Synovial biopsy and Cardiac scintigraphy with [99mTc]Tc-DPD
- How many people
- 100 participants
- Where
- 2 sitesPortugal
- Study dates
- 1 Jun 2020to 1 Jun 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with ≥60 years old submitted to hand surgery
Who may be able to join
- . Patients aged ≥ 60 years old with symptomatic idiopathic carpal tunnel syndrome or other hand surgery indications.
Who cannot join
- . Diabetes mellitus, hypothyroidism, hemodialysis, rheumatoid arthritis, and other inflammatory arthropathies, multiple myeloma, gout, chondrocalcinosis, Colles fracture, space-occupying lesions, and infectious synovitis.
Trial locations and contacts
2 sites in 1 country.
Portugal2 sites, 2 recruiting
- Recruiting
Centro Hospitalar Universitário São João
Porto, 4200-319
Elisabete Martins, MD, PhD, (+351) 965913480, ebernardes@med.up.pt
Elisabete Martins, MD, PhD
- Recruiting
Faculty of Medicine (FMUP)
Porto, 4200-319
Janete Santos, PhD, (+351) 225 513 600, investigaclinica@med.up.pt
About this study
Official title: Systemic Transthyretin Amyloidosis: Carpal Tunnel Syndrome in a Portuguese Population (CarPoS Study)
Systemic transthyretin amyloidosis is an aging-related disorder. It is usually associated with cardiac disease but also extends to other organs. Recent studies found that idiopathic carpal tunnel syndrome patients may have amyloid deposition in tenosynovial tissue. The main aims of this project are the characterization of the association between idiopathic carpal tunnel syndrome and transthyretin amyloidosis and its evaluation as a predictive factor of cardiac amyloidosis
- Conditions
- Transthyretin Amyloidosis, Carpal Tunnel Syndrome
- Being tested
- Synovial biopsy and Cardiac scintigraphy with [99mTc]Tc-DPD
- Medical subject headings
- Amyloidosis, Hereditary, Transthyretin-Related, Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synovial biopsy and Cardiac scintigraphy with [99mTc]Tc-DPDDiagnostic test
Congo red and Immunohistochemical analysis and/or Mass spectrometry analysis
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Patients aged ≥ 60 years old with symptomatic carpal tunnel syndrome submitted to surgery Receives: Diagnostic Test: Synovial biopsy and Cardiac scintigraphy with [99mTc]Tc-DPD | |
| Group 2 | Patients aged ≥ 60 years old without symptomatic carpal tunnel syndrome submitted to hand surgery Receives: Diagnostic Test: Synovial biopsy and Cardiac scintigraphy with [99mTc]Tc-DPD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of transthyretin amyloidosis in synovial in patients with ≥60 years old
Number of patients with transthyretin amyloidosis in synovial in relation to total number of patients submitted to hand surgery
Measured: 24 months
Secondary outcomes (2)
Association between synovial transthyretin amyloidosis with carpal tunnel syndrome
Comparison between group 1 and 2
Measured: 24 months
Association between idiopathic carpal tunnel syndrome with cardiac transthyretin amyloidosis
Comparison between group 1 and 2
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2022
- Study start1 Jun 2020
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jun 2025 (estimated)
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.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Collaborators
- Centro Hospitalar De São João, E.P.E., Centro de Investigação em Tecnologias e Serviços de Saúde, Rede de Investigação em Saúde
- Responsible party
- Sponsor
- Investigators
- Elisabete Martins, MD, PhD, Principal investigator, Universidade do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05409833
- Sponsor's protocol ID
- CarPoS
- Acronym
- CarPoS
- Status last verified
- Jun 2023
- First submitted
- 3 Jun 2022
- Last updated
- 19 Oct 2023
- 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 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systemic Transthyretin Amyloidosis: Carpal Tunnel Syndrome in a Portuguese Population (CarPoS Study)
- ClinicalTrials.gov ID
- NCT05409833
- Acronym / sponsor ID
- CarPoS / CarPoS
- Conditions
- Transthyretin Amyloidosis, Carpal Tunnel Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Collaborators
- Centro Hospitalar De São João, E.P.E., Centro de Investigação em Tecnologias e Serviços de Saúde, Rede de Investigação em Saúde
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 8 Jun 2022 (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.
Systemic transthyretin amyloidosis is an aging-related disorder. It is usually associated with cardiac disease but also extends to other organs. Recent studies found that idiopathic carpal tunnel syndrome patients may have amyloid deposition in tenosynovial tissue. The main aims of this project are the characterization of the association between idiopathic carpal tunnel syndrome and transthyretin amyloidosis and its evaluation as a predictive factor of cardiac amyloidosis
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Diagnostic Test: Synovial biopsy and Cardiac scintigraphy with [99mTc]Tc-DPDPatients aged ≥ 60 years old with symptomatic carpal tunnel syndrome submitted to surgery |
| Group 2 | – | Diagnostic Test: Synovial biopsy and Cardiac scintigraphy with [99mTc]Tc-DPDPatients aged ≥ 60 years old without symptomatic carpal tunnel syndrome submitted to hand surgery |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with ≥60 years old submitted to hand surgery
Key inclusion criteria (1 listed)
- . Patients aged ≥ 60 years old with symptomatic idiopathic carpal tunnel syndrome or other hand surgery indications.
Key exclusion criteria (1 listed)
- . Diabetes mellitus, hypothyroidism, hemodialysis, rheumatoid arthritis, and other inflammatory arthropathies, multiple myeloma, gout, chondrocalcinosis, Colles fracture, space-occupying lesions, and infectious synovitis.
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 |
|---|---|---|
| Synovial biopsy and Cardiac scintigraphy with [99mTc]Tc-DPDCongo red and Immunohistochemical analysis and/or Mass spectrometry analysis | Diagnostic test | Group 1, Group 2 |
Primary outcome
Frequency of transthyretin amyloidosis in synovial in patients with ≥60 years old
Time frame: 24 months
Number of patients with transthyretin amyloidosis in synovial in relation to total number of patients submitted to hand surgery
2 secondary outcomes
Association between synovial transthyretin amyloidosis with carpal tunnel syndrome
Time frame: 24 months
Association between idiopathic carpal tunnel syndrome with cardiac transthyretin amyloidosis
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2023.
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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.
Elisabete Martins, MD, PhD principal investigator
Universidade do Porto
2 sites 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 Universidade do Porto at 2 sites in Portugal.
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 1 inclusion and 1 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 19 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Portugal. 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?
Contact Elisabete Martins, MD, PhD ((+351) 965913480, ebernardes@med.up.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of transthyretin amyloidosis in synovial in patients with ≥60 years old (time frame: 24 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 19 Oct 2023.