ClinicalTrials.gov record NCT07580872
Early Screening for Cardiac Amyloid Using a History of Bilateral Carpal Tunnel Syndrome
Investigations in Early Screening for Cardiac Amyloid Through History of Bilateral Carpal Tunnel Syndrome
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AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This diagnostic study screens people with a history of bilateral carpal tunnel syndrome for previously undiagnosed cardiac amyloidosis. Participants will have a Technetium-99m pyrophosphate (Tc-99m PYP) heart scan to look for transthyretin (ATTR) deposits. The study will estimate how common cardiac amyloidosis is in this group.
What it is studying. Whether people with prior bilateral carpal tunnel syndrome have previously undiagnosed cardiac transthyretin (ATTR) amyloid detectable by Tc-99m PYP scanning, and the prevalence of cardiac amyloidosis in this group.
What the researchers hope to learn. Estimate how often cardiac transthyretin amyloid is found among people with prior bilateral carpal tunnel syndrome and evaluate PYP scanning as a way to identify previously undiagnosed cases.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Diagnostic test
- Technetium-99m Pyrophosphate (Tc-99m PYP) Scan
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- 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.
Exclusion criteria
- 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
Study description and what participation involves
The registry record has no detailed description beyond the summary above.
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AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
If eligible, you would allow review of your medical and surgical records to confirm the history of bilateral carpal tunnel surgery and then undergo a Technetium-99m pyrophosphate (Tc-99m PYP) cardiac scan (a nuclear heart imaging test) to look for transthyretin-related cardiac amyloid. The registry does not give a full schedule of visits or other tests. If you decline the PYP scan you are not eligible to participate.
How the study is structured. Interventional diagnostic study in a single group: all participants with a documented history of bilateral carpal tunnel syndrome receive a Technetium-99m pyrophosphate (Tc-99m PYP) heart scan. There is no masking; outcomes include presence of cardiac amyloidosis measured over one year.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- The registry lists this study under Bilateral Carpal Tunnel Syndrome (Diagnosis); Cardiac Amyloidosis. Does it apply to my diagnosis?
- The registry says recruitment has not started. When is it expected to open, and can I register interest now?
- No sites are listed on the registry yet. Where will the study take place?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on wild-type ATTR amyloidosis
This trial is also listed on this site under ATTRv amyloidosis.
Important dates
- Study start
- July 2026 (estimated)
- Primary completion
- July 2027 (estimated)
- Study completion
- January 2028 (estimated)
- Target enrollment
- 139 participants (estimated)
- Last updated on registry
- May 12, 2026
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Principal investigator
- Ryan Davey, Associate Professor, Western University - Lead London Heart Failure Sciences
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Participating sites
Study locations have not been posted on ClinicalTrials.gov yet. This study is not yet recruiting, so sites may be added when recruitment begins.
Terms used on this page · explanations by MedicalUpdates.ai
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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