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

Официальное название

Investigations in Early Screening for Cardiac Amyloid Through History of Bilateral Carpal Tunnel Syndrome

Обзор

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.

Вмешательства

• Диагностический тест Technetium-99m Pyrophosphate (Tc-99m PYP) Scan
  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.

Первичные конечные точки

• Presence of Cardiac Amyloidosis [Срок оценки: 1 year]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07580872 · WREM - 126731

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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