Carpal Tunnel Syndrome and Amyloid Cardiomyopathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Incidence of transthyretin (TTR) amyloidosis in patients undergoing carpal tunnel release surgery
研究概览
简要总结
The investigators will prospectively evaluate tissue samples obtained from patients undergoing carpal tunnel release surgery for amyloid in the soft tissue that is removed. Patients who have tissue that stains positive for amyloid will undergo cardiac testing to look for evidence of cardiac involvement.
详细描述
Since the 1970s, the connection between amyloidosis and carpal tunnel syndrome has been described, with tenosynovial tissue staining positive for amyloid fibril deposition. Up to 30% of patients in prior studies with idiopathic carpal tunnel syndrome have biopsy tissue that stains positive for amyloid deposition. However, the prevalence of cardiac involvement at the time of carpal tunnel syndrome surgery has not been established. Furthermore, the role of TTR kinetic stability in the disease progression of amyloidosis is unclear.
Diagnosing TTR amyloidosis at the time of carpal tunnel involvement could lead to an earlier identification of the disease at a stage where the cardiomyopathy may be occult or less advanced. In addition, abnormal TTR kinetics may even precede tissue deposition in the flexor tendon retinaculum. As several emerging pharmacological strategies are in development that may slow or even halt TTR amyloidosis, earlier diagnosis is advantageous. Identification and implementation of therapy for prevention or early disease treatment may alter the natural history of this progressive systemic disease.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males ≥ 50 years of age
- •Females ≥ 60 years of age
- •Undergoing carpal tunnel release surgery (adequate symptoms are not responding to conservative management requiring surgery)
- •Able to consent
- •Underwent carpal tunnel surgery and biopsy within last 30 days, if the study was discussed prior to surgery by one of the study physicians.
排除标准
- •Secondary CTS (Hemodialysis, rheumatoid arthritis, trauma)
- •Known diagnosis of amyloidosis
结局指标
主要结局
Incidence of transthyretin (TTR) amyloidosis in patients undergoing carpal tunnel release surgery
时间窗: Biopsy completed on day of surgery
Identify the incidence of TTR amyloid deposits in the soft tissue of patients undergoing carpal tunnel surgery for idiopathic carpal tunnel syndrome
Cardiac progression of transthyretin (TTR) amyloidosis in carpal tunnel biopsy-positive patients
时间窗: 4 years from baseline cardiac assessment.
Assess the progression of cardiac disease in patients with TTR deposits found in soft tissue removed at the time of carpal tunnel surgery
次要结局
- Early transthyretin (TTR) amyloid cardiomyopathy identification in carpal tunnel biopsy-positive patients(Baseline and annual testing for 4 years in biopsy-positive patients)
- Prevalence of abnormal transthyretin (TTR) kinetics in patients undergoing carpal tunnel surgery(One-time kinetics test for biopsy-negative patients; baseline kinetics and annually for 4 years in biopsy-positive patients)
研究者
Mazen Hanna MD
Prinicipal Investigator
The Cleveland Clinic