Prevalence and Long Tem Follow up of ATTR Cardiac Amyloidosis in a Selected Population of Patients Operated on Carpal Tunnel Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Frequency of ATTR in CTS
研究概览
简要总结
Patients operated for carpal tunnel syndrome (CTS) at Ålesund Hospital (200 patients) will have a biopsy to diagnose ATTR amyloidosis. Patients with positive biopsy will be examined to decide wether they have cardiac amyloidosis. All patients with positive biopsy will be followed closely for 10 years wit echocardiography an clinically.
详细描述
Biopsy proven ATTR (v/wt) amyloidosis inpatients operated with CTS will undergo standard guidelines recommended examinations as 99mTcDPD SPECT CT, echocardiography, ECG, Holter, genetic testing (v/wt), and lab testing, and CMRI as indicated. Exclusion of light chain disease will be done.
All patients will be followed at least yearly as indicated by guidelines (ESC), and patients with development of cardiac amyloidosis will get standard treatment in accordance with guidelines and as approved by the Norwegian government. All patients will be followed for 10 years.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Male > 50 years
- •Female > 60 years
- •operated CTS at Ålesund Hospital
排除标准
- •not consented
- •do not speak Norwegian
- •secondary cause of CTS as traumatic or rheumatic
- •cannot be followed > 5 years due to other medical conditions
- •Cardiac disease at time of operation for CTS
结局指标
主要结局
Frequency of ATTR in CTS
时间窗: 2 years
Biopsy proven ATTR
Cardiac involvement in patients with biopsy proven ATTR
时间窗: 10 years
Scintigraphic and echocardiographic cardiac involvement possibly cMRI
次要结局
未报告次要终点