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临床试验/NCT05793320
NCT05793320已完成不适用

Prospective Histopathologic and Clinical Evaluation of Patients Undergoing Carpal Tunnel Release With Risk Markers for Amyloidosis

Henry Ford Health System1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2023年8月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
250
试验地点
1
主要终点
Rate of amyloid positivity

研究概览

简要总结

Bilateral carpal tunnel syndrome has been demonstrated in previous literature to be a warning sign for potential amyloidosis. One study has been performed in which patients with bilateral carpal tunnel syndrome underwent tissue biopsy (either tendon sheath or transverse carpal ligament) at the time of carpal tunnel release to determine the strength of association as well as most common subtypes. However, no study has been done demonstrating whether or not patients with amyloid-positive carpal tunnel biopsy would benefit from an early referral to cardiology for a work-up of potential cardiac amyloidosis. In our study, patients with bilateral carpal tunnel symptoms who are indicated for carpal tunnel release would be identified in clinic and undergo biopsy for congo red staining at the time of surgery. All patients with positive biopsy results would be referred to cardiology. Outcomes would include the rate of amyloid positivity, common subtypes, and echocardiographic findings after cardiac referral.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

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

入选标准

  • •Positive screening is defined as two characteristics from Tier 1 or one characteristic from Tier 1 and one from Tier 2 Tier 1
  • •Male > 50 years old
  • •Female > 60 years old
  • •Bilateral carpal tunnel symptoms or prior release surgery Tier 2
  • •Spinal stenosis
  • •History of biceps tendon rupture
  • •Atrial fibrillation or flutter (active or previous history)
  • •Pacemaker
  • •Congestive heart failure
  • •Family history of transthyretin amyloidosis (ATTR)

排除标准

  • •Unable or unwilling to follow up with cardiology.
  • •Previous diagnosis of cardiac amyloidosis.

研究组 & 干预措施

Carpal Tunnel Release

Experimental

干预措施: Carpal Tunnel Release Surgery (Procedure)

结局指标

主要结局

Rate of amyloid positivity

时间窗: Biopsy sent for testing immediately after the procedure

How many patients who participate in study have positive biopsy for amyloidosis.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Charles S Day

Interim Chairman & Medical Director, Professor of Orthopaedic Surgery, Department of Orthopaedic Surgery & Service Line, Wayne State University School of Medicine, Henry Ford Health

Henry Ford Health System

研究点 (1)

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