Bilateral Carpal Tunnel Syndrome (Diagnosis)NCT07580872
Early Screening for Cardiac Amyloid Using a History of Bilateral Carpal Tunnel Syndrome
A study testing Technetium-99m Pyrophosphate (Tc-99m PYP) Scan in people with Bilateral Carpal Tunnel Syndrome (Diagnosis) and Cardiac Amyloidosis, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's.
Trial summary
Cardiac amyloidosis is a condition where abnormal protein deposits build up in the heart, making it stiff and causing it to work less effectively. One common type is caused by a normal blood protein called transthyretin (TTR), which can become unstable and form these deposits. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Bilateral Carpal Tunnel Syndrome (Diagnosis), Cardiac Amyloidosis
- What is being tested?
- Technetium-99m Pyrophosphate (Tc-99m PYP) Scan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- No sites listed yet
- Study dates
- Jul 2026to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 55 and older at the time of surgery.
- Patients who have had bilateral carpal tunnel release surgery (i.e., at least two carpal tunnel release surgeries, one for each hand).
- Patients who underwent surgery between the years 2010-2015.
Who cannot join
- Patients under the age of 55 at time of surgery.
- Patients who had unilateral carpal tunnel release surgery or surgery on only one hand.
- Patients known alternative neurologic diagnosis explaining CTS
- Patients with incomplete medical records
- Patient denies PYP scan
- Previously diagnosed amyloidosis through previous positive PYP, medical notes or self-reported
- Patients with prior negative amyloid work up
- Cognitive/communication issues without available translation support
About this study
Official title: Investigations in Early Screening for Cardiac Amyloid Through History of Bilateral Carpal Tunnel Syndrome
Cardiac amyloidosis is a condition where abnormal protein deposits build up in the heart, making it stiff and causing it to work less effectively. One common type is caused by a normal blood protein called transthyretin (TTR), which can become unstable and form these deposits. When this happens, it is called ATTR-CM, a form of heart disease caused by TTR protein buildup. This can lead to symptoms like tiredness, shortness of breath, or swelling.
Bilateral carpal tunnel syndrome (CTS) is recognized as an early clinical sign of systemic amyloidosis, especially in the context of TTR amyloidosis, where amyloid deposits accumulate in the median nerve. Early identification of cardiac amyloidosis, particularly in patients with bilateral CTS, may allow for earlier intervention with disease-modifying therapies, such as tafamidis, which has been shown to improve survival and reduce hospitalizations in patients with cardiac amyloidosis.
The purpose of this study is to identify patients to evaluate them for previously undiagnosed cardiac amyloidosis. The collected information will help estimate the prevalence of cardiac amyloidosis among participants with prior bilateral CTS using a PYP nuclear scan (technetium-99m pyrophosphate scan). A PYP scan is a special heart imaging test that helps doctors see if certain abnormal proteins are building up in the heart. It's mainly used to help diagnose cardiac amyloidosis.
- Being tested
- Technetium-99m Pyrophosphate (Tc-99m PYP) Scan
- Medical subject headings
- Disease, Amyloid Neuropathies, Familial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technetium-99m Pyrophosphate (Tc-99m PYP) ScanDiagnostic test
In this study, Technetium-99m pyrophosphate (Tc-99m PYP) cardiac scintigraphy will be performed in participants with a documented history of bilateral carpal tunnel syndrome, a recognized extracardiac manifestation associated with transthyretin (ATTR) amyloidosis. The purpose of this imaging intervention is to evaluate for the presence of cardiac transthyretin amyloid deposition in an at-risk population.
| Study group | Role | What they receive |
|---|---|---|
| History of Bilateral Carpal Tunnel syndrome | Experimental | Not described Receives: Diagnostic Test: Technetium-99m Pyrophosphate (Tc-99m PYP) Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of Cardiac Amyloidosis
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study startJul 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bilateral Carpal Tunnel Syndrome (Diagnosis)Studies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 139 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ryan Davey, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07580872
- Sponsor's protocol ID
- WREM - 126731
- Status last verified
- May 2026
- First submitted
- 22 Apr 2026
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigations in Early Screening for Cardiac Amyloid Through History of Bilateral Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT07580872
- Acronym / sponsor ID
- WREM - 126731
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 139 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- Jul 2026 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 12 May 2026 (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.
Cardiac amyloidosis is a condition where abnormal protein deposits build up in the heart, making it stiff and causing it to work less effectively. One common type is caused by a normal blood protein called transthyretin (TTR), which can become unstable and form these deposits. When this happens, it is called ATTR-CM, a form of heart disease caused by TTR protein buildup. This can lead to symptoms like tiredness, shortness of breath, or swelling.
Bilateral carpal tunnel syndrome (CTS) is recognized as an early clinical sign of systemic amyloidosis, especially in the context of TTR amyloidosis, where amyloid deposits accumulate in the median nerve. Early identification of cardiac amyloidosis, particularly in patients with bilateral CTS, may allow for earlier intervention with disease-modifying therapies, such as tafamidis, which has been shown to improve survival and reduce hospitalizations in patients with cardiac amyloidosis.
The purpose of this study is to identify patients to evaluate them for previously undiagnosed cardiac amyloidosis. The collected information will help estimate the prevalence of cardiac amyloidosis among participants with prior bilateral CTS using a PYP nuclear scan (technetium-99m pyrophosphate scan). A PYP scan is a special heart imaging test that helps doctors see if certain abnormal proteins are building up in the heart. It's mainly used to help diagnose cardiac amyloidosis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| History of Bilateral Carpal Tunnel syndrome | Experimental | Diagnostic Test: Technetium-99m Pyrophosphate (Tc-99m PYP) Scan |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 55 and older at the time of surgery.
- Patients who have had bilateral carpal tunnel release surgery (i.e., at least two carpal tunnel release surgeries, one for each hand).
- Patients who underwent surgery between the years 2010-2015.
Key exclusion criteria (8 listed)
- Patients under the age of 55 at time of surgery.
- Patients who had unilateral carpal tunnel release surgery or surgery on only one hand.
- Patients known alternative neurologic diagnosis explaining CTS
- Patients with incomplete medical records
- Patient denies PYP scan
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 |
|---|---|---|
| Technetium-99m Pyrophosphate (Tc-99m PYP) ScanIn this study, Technetium-99m pyrophosphate (Tc-99m PYP) cardiac scintigraphy will be performed in participants with a documented history of bilateral carpal tunnel syndrome, a recognized extracardiac manifestation associated with transthyretin (ATTR) amyloidosis. The purpose of this imaging intervention is to evaluate for the presence of cardiac transthyretin amyloid deposition in an at-risk population. | Diagnostic test | History of Bilateral Carpal Tunnel syndrome |
Primary outcome
Presence of Cardiac Amyloidosis
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Technetium-99m Pyrophosphate (Tc-99m PYP) Scan in people with Bilateral Carpal Tunnel Syndrome (Diagnosis) and Cardiac Amyloidosis, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's.
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 3 inclusion and 8 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: opening soon, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Presence of Cardiac Amyloidosis (time frame: 1 year). 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 12 May 2026.