Prevalence of Wild-Type Transthyretin Cardiac Amyloidosis Among Patients Undergoing Carpal Tunnel Release Surgery - A Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 109
- 试验地点
- 2
- 主要终点
- Prevalence of wild-type transthyretin cardiac amyloidosis in patients undergoing surgery for idiopathic Carpal Tunnel Syndrome Surgery where biopsies from transverse carpal ligament stain positive for amyloid.
研究概览
简要总结
Patients above the age of 60 will be recruited at their carpal tunnel release surgery. Biopsies will be taken from the wrist and examined for the presence of amyloid protein. A amyloid-positive biopsy will refer the patients for cardiac examination including blod- and urine samples examined for transthyretin.
If the result of the cardiac examination is suspected cardiac amyloidosis, the patient will be referred for a diagnostic TC99-DPD scintigraphy. If the scintigraphy is positive, the patient will be referred for right heart catherization (RHC) and an exercise test.
Myocardial biopsies will be taken at the RHC and examined with electron microscopy and high resolution respirometry.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males above 65 years of age, females above 75 years of age.
- •Scheduled idiopathic carpal tunnel release surgery.
- •Informed written consent.
排除标准
- •Operation by other indication, e.g.
- •Known amyloidosis
结局指标
主要结局
Prevalence of wild-type transthyretin cardiac amyloidosis in patients undergoing surgery for idiopathic Carpal Tunnel Syndrome Surgery where biopsies from transverse carpal ligament stain positive for amyloid.
时间窗: Through study completion, 6 years.
We will examine the amyloid deposits prevalence in biopsies from the Carpal Tunnel and ATTRwt prevalence in an aged and predominantly male population operated for idiopathic Carpal Tunnel Syndrom. Diagnosis of wild-type cardiac amyloidosis will be determined by TC99-DPD scintigraphy, endomyocardial biopsy, or both. Biopsies will be examined using Congo Red staining and fluorescent light
次要结局
- Comparing patients diagnosed with wild-type transthyretin cardiac amyloidosis due to screening with age and gender matched clinically diagnosed ATTRwt patients.(Through study completion, 6 years.)
- Levels of transthyretin in blood and urine from patients with suspected wild-type transthyretin cardiac amyloidosis(Has been added after study start, will run through study completion, 3 years.)
研究者
Steen Hvitfeldt Poulsen
Professor, DMSc
Aarhus University Hospital Skejby