NCT05701397招募中不适用
Prevalence of Cardiac Amyloidosis in Patients Undergoing Surgery for Lumbar Spinal Stenosis.
Steen Hvitfeldt Poulsen2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Diagnosis of cardiac amyloidosis
研究概览
简要总结
Patients undergoing surgery for lumbar spinal stenosis will have biopsies of the ligamentum flavum sent to the department of pathology for histologic screening.
If the ligament biopsy contains amyloid, patients will receive an echocardiogram, an ecg, biomarker testing, and a bone tracer scintigraphy diagnostic of cardiac amyloidosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 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
- •Scheduled for surgery for lumbar spinal stenosis
- •Age > 65 years
- •Informed written consent
排除标准
- •Known amyloidosis
- •Myelomatosis
- •Monoclonal gammopathy of unknown significance, MGUS
- •Morbus Waldenstrøm
结局指标
主要结局
Diagnosis of cardiac amyloidosis
时间窗: 1 year
DPD scintigraphy with a Perugini Grade 2 og higher.
次要结局
未报告次要终点
研究者
Steen Hvitfeldt Poulsen
Professor, PhD, DMSci
Aarhus University Hospital Skejby
研究点 (2)
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