Screening for Systemic Amyloidosis Via the Ligamentum Flavum
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Incidence of amyloidosis in older patients undergoing spinal stenosis surgery
研究概览
简要总结
The investigators will prospectively evaluate for the presence of amyloid deposits in ligamentum flavum (yellow ligament) tissue samples obtained from patients undergoing spinal stenosis surgery. Patients who have tissue that stains positive for amyloid will be referred to an amyloidosis specialist.
详细描述
Similar to carpal tunnel syndrome, spinal stenosis is associated with systemic amyloidosis and presents earlier than cardiac amyloidosis symptoms - 21-45% of ATTR patients and case reports in AL patients. The investigators' recent study found that 10% of older patients undergoing carpal tunnel release surgery were positive for amyloidosis, with 20% of that group presenting with cardiac involvement. 70% of the amyloid-positive group had a history of spinal stenosis and 40% required surgical intervention. Surgical intervention for spinal stenosis could provide an opportunity to screen for amyloidosis through yellow ligament (ligamentum flavum) biopsy.
This study will look at the prevalence of amyloidosis in patients undergoing surgical intervention for non-congenital spinal stenosis and spondyloarthropathy. The investigators hypothesize that 10% of such patients will be positive for amyloidosis.
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
- •Age ≥50 years
- •Undergoing surgical intervention for non-congenital spinal stenosis and/or spondyloarthropathy
- •Able to consent
排除标准
- •History of congenital spinal stenosis or congenital spondyloarthropathy
结局指标
主要结局
Incidence of amyloidosis in older patients undergoing spinal stenosis surgery
时间窗: Baseline to 30 days
Incidence of amyloid deposits in removed ligamentum flavum tissue of older patients undergoing spinal stenosis surgery
次要结局
未报告次要终点
研究者
Mazen Hanna MD
Principle Investigator
The Cleveland Clinic