此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

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

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.

研究概览

研究类型

介入性

注册 (估计的)

139

阶段

  • 不适用

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:诊断
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:History of Bilateral Carpal Tunnel syndrome
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.

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Presence of Cardiac Amyloidosis
大体时间:1 year
1 year

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年7月1日

初级完成 (估计的)

2027年7月1日

研究完成 (估计的)

2028年1月1日

研究注册日期

首次提交

2026年4月22日

首先提交符合 QC 标准的

2026年5月5日

首次发布 (实际的)

2026年5月12日

研究记录更新

最后更新发布 (实际的)

2026年5月12日

上次提交的符合 QC 标准的更新

2026年5月5日

最后验证

2026年5月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅