Early Screening for Cardiac Amyloid Using a History of Bilateral Carpal Tunnel Syndrome

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55+
SponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Technetium-99m Pyrophosphate (Tc-99m PYP) Scan

    Diagnostic 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.

Treatment groups

139 Participants
are divided into 1 treatment group
Group A: History of Bilateral Carpal Tunnel syndromeExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Presence of Cardiac Amyloidosis

Time frame
1 year

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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