跳至主要内容
临床试验/NCT06186167
NCT06186167招募中不适用

Histopathological Incidence of Amyloidosis in High-Risk Patients Undergoing Cardiac Device Implantation

Midwest Heart & Vascular Specialists1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年1月29日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
Diagnostic yield of chest wall fat pad biopsy for cardiac amyloidosis

研究概览

简要总结

This single-practice prospective cohort study aims to enhance the diagnosis of cardiac amyloidosis in high-risk patients undergoing standard cardiac device implantation. By analyzing chest wall fat tissue, which is usually discarded, we aim to determine the diagnostic yield of such biopsies for amyloidosis and to develop a predictive screening model based on clinical, lab, and imaging data. The study, running from December 2023 to December 2024, expects to enroll 100 patients and may provide a new, non-invasive diagnostic avenue for this condition.

详细描述

The study targets a key gap in cardiac amyloidosis diagnosis by systematically evaluating the histopathological incidence of the disease using chest wall fat pad biopsies-tissue that is typically discarded during the implantation of cardiac devices like pacemakers, ICDs, and CRT-D/Ps. Standard surgical procedures are adhered to, ensuring minimal additional risk to patients. The collected tissue samples are analyzed by the HCA pathology laboratory to detect amyloid deposits, thereby potentially identifying amyloidosis in a non-invasive manner. In addition to the primary endpoint of histopathological diagnosis, the study retrospectively aims to validate a predictive model that incorporates a wide range of data to streamline the identification of patients at high risk for cardiac amyloidosis. Strict measures are in place to protect patient confidentiality and data security. By potentially improving diagnostic efficiency, this research could contribute to earlier detection and treatment strategies, thus improving patient outcomes for those at high risk of this life-threatening condition.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who are 40 years of age or older
  • Patients who are able and willing to provide informed consent
  • Patients who are scheduled for CIED implantation within the study period and with clinical lab and imaging features suggestive of cardiac amyloidosis

排除标准

  • Individuals below the age of
  • Persons who are unable to consent or who do not consent to participate.
  • Patients who have already been diagnosed with cardiac amyloidosis prior to the study

结局指标

主要结局

Diagnostic yield of chest wall fat pad biopsy for cardiac amyloidosis

时间窗: December 2023 to December 2024, corresponding to the study duration during which patients will be enrolled and outcomes will be assessed

The primary outcome measure is the histopathologic diagnosis of amyloidosis in chest wall fat tissue removed during cardiac device implantation

次要结局

  • Development of a predictive screening model for cardiac amyloidosis(Retrospective analysis of patient data collected from December 2023 to December 2024)

研究者

发起方
Midwest Heart & Vascular Specialists
申办方类型
Other
责任方
Sponsor

研究点 (1)

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