AmyloidosisAMICARNCT04245098
Carpal Tunnel Syndrome and Amyloidosis
A study testing Carpal tunnel syndrome surgery in people with Amyloidosis and Carpal Tunnel Syndrome, run by Corporacion Parc Tauli at 1 site in Spain.
Trial summary
Carpal tunnel syndrome has been suggested to be an early sign of amyloidosi. The investigators will evaluate tissue samples obtained from patients undergoing carpal tunnel release surgery for amyloid. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Amyloidosis, Carpal Tunnel Syndrome
- What is being tested?
- Carpal tunnel syndrome surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 8 Jan 2020to 8 Jan 2023
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients undergoing carpal tunnel syndrome surgery
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Maria Del Carmen Navarro-Saez
Sabadell, Barcelona, 08208
Maria del Carmen Navarro-Saez, M.D., 937 231 010 ext. 21990, mnavarros@tauli.cat
Carlos Feijoo-Massó, M.D.
About this study
Carpal tunnel syndrome has been suggested to be an early sign of amyloidosi. The investigators will evaluate tissue samples obtained from patients undergoing carpal tunnel release surgery for amyloid.
Read the detailed description
Carpal tunnel syndrome (CTS) can be caused by the deposition and accumulation of misfolded proteins called amyloid and is often an early manifestation of systemic amyloidosis.
Patients with cardiac amyloidosis often have carpal tunnel syndrome that precedes cardiac manifestations by several years, and many patients will have undergone surgery for idiopathic carpal tunnel syndrome since the protein also deposits in the transversal carpal ligament of the hand.
The investigators sought to identify the prevalence and type of amyloid deposits in patients undergoing carpal tunnel surgery and evaluate for cardiac involvement
- Conditions
- Amyloidosis, Carpal Tunnel Syndrome
- Being tested
- Carpal tunnel syndrome surgery
- Keywords
- carpal tunnel syndrome, amyloidosis
- Medical subject headings
- Amyloidosis, Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carpal tunnel syndrome surgeryProcedure or surgery
Biopsy
| Study group | Role | What they receive |
|---|---|---|
| Amyloid | Experimental | Biopsy Receives: Procedure: Carpal tunnel syndrome surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with amyloid deposits in patients undergoing carpal tunnel surgery
Prevalence of amyloid deposits in biopsy in patients undergoing carpal tunnel syndrome surgery
Measured: 2 years
Secondary outcomes (1)
Number of participants with cardiac involvement in echocardiogram
Cardiac involment in echocardiography
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study start8 Jan 2020
- Primary completion8 Jan 2022 (estimated)
- Study completion8 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria del Carmen Navarro-Saez, Corporacion Parc Tauli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04245098
- Sponsor's protocol ID
- CSPT_AMICAR1
- Acronym
- AMICAR
- Status last verified
- Jan 2020
- First submitted
- 22 Jan 2020
- Last updated
- 28 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carpal Tunnel Syndrome and Amyloidosis
- ClinicalTrials.gov ID
- NCT04245098
- Acronym / sponsor ID
- AMICAR / CSPT_AMICAR1
- Conditions
- Amyloidosis, Carpal Tunnel Syndrome
- Keywords
- carpal tunnel syndrome, amyloidosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Study start
- 8 Jan 2020 (actual)
- Primary completion
- 8 Jan 2022 (estimated)
- Study completion
- 8 Jan 2023 (estimated)
- First posted
- 28 Jan 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.
Carpal tunnel syndrome has been suggested to be an early sign of amyloidosi. The investigators will evaluate tissue samples obtained from patients undergoing carpal tunnel release surgery for amyloid.
Detailed description
Carpal tunnel syndrome (CTS) can be caused by the deposition and accumulation of misfolded proteins called amyloid and is often an early manifestation of systemic amyloidosis.
Patients with cardiac amyloidosis often have carpal tunnel syndrome that precedes cardiac manifestations by several years, and many patients will have undergone surgery for idiopathic carpal tunnel syndrome since the protein also deposits in the transversal carpal ligament of the hand.
The investigators sought to identify the prevalence and type of amyloid deposits in patients undergoing carpal tunnel surgery and evaluate for cardiac involvement
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Amyloid | Experimental | Procedure: Carpal tunnel syndrome surgeryBiopsy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing carpal tunnel syndrome surgery
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Carpal tunnel syndrome surgeryBiopsy | Procedure or surgery | Amyloid |
Primary outcome
Number of participants with amyloid deposits in patients undergoing carpal tunnel surgery
Time frame: 2 years
Prevalence of amyloid deposits in biopsy in patients undergoing carpal tunnel syndrome surgery
1 secondary outcome
Number of participants with cardiac involvement in echocardiogram
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2020.
- Individual participant dataSharing planned: No
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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?
A study testing Carpal tunnel syndrome surgery in people with Amyloidosis and Carpal Tunnel Syndrome, run by Corporacion Parc Tauli at 1 site in Spain.
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 28 Jan 2020. 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 Spain. 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 Maria del Carmen Navarro-Saez, M.D. (937 231 010 ext. 21990, mnavarros@tauli.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with amyloid deposits in patients undergoing carpal tunnel surgery (time frame: 2 years). 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 28 Jan 2020.