Contribution of Systematic Pathological Examination of Orthopaedic Specimens to the Early Diagnosis of Tranthyretin Amyloid Heart Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- frequency of ATTR amyloidosis
研究概览
简要总结
The goal of this observational study is to learn about the frequency of ATTR amyloid, cardiac involvement and associated features, in 150 patients aged 50 or more years, and operated for an idiopathic carpal tunnel syndrome, lumbar spine stenosis or total hip or knee arthroplasty for primary osteoarthritis. The main questions to be answered are:
- What is the frequency of ATTR deposits in samples retrieved during surgery?
- What is the frequency of cardiac involvement in ATTR positive patients?
- What are the preoperative predictors of ATTR deposits? Participants will
- have operative samples stained by Congo red in search of amyloid, which will be typed by immunochemistry in positive samples,
- undergo a multimodal imaging search for cardiac involvement, if ATTR is identified,
- undergo a preoperative complete clinical examination, including collection of medical history, ECG, biochemical tests, and imaging (ultrasound scans of rotator cuff and hip capsule in all participating patients, of the carpal tunnel in patients operated at this site, and MRI + standing profile radiography of the lumbar spine, in patients operated for lumbar stenosis)
- ATTR positive patients will be proposed to be followed-up by a reference center, with the aim of an early diagnosis of cardiac involvement, allowing efficient mamagement.
Researchers will assess the frequency of ATTR deposits at each operated site, the frequency or ATTR cardiopathy in ATTR + patients, and will compare demographic, clinical, biochemical, and imaging features in patients with and without ATTR deposits, to guide the indications of pathological examination during these frequent orthopedic surgeries
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
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
- •patients aged 50 or over
- •having signed an informed consent form
- •undergoing surgery for
- •idiopathic carpal tunnel syndrome
- •or lumbar spinal canal stenosis
- •or prosthetic replacement of a hip or knee for primary osteoarthritis
排除标准
- •secondary carpal tunnel syndrome (inflammatory rheumatism, diabetes, hypothyroidism, etc.)
- •Indication of prosthesis for a condition other than primary osteoarthritis.
- •Known amyloidosis
- •Refusal of consent
- •Inability to understand the study
- •Age < 50 years
结局指标
主要结局
frequency of ATTR amyloidosis
时间窗: 18 months
presence of ATTR amyloidosis in surgical samples by immunohistochemistry performed when samples countain amyloi by Congo red.ATTR will be semiquantitalively assessed using a published scale.
次要结局
- proportion of wild type and hereditary ATTR(20 months)
- Description of preoperative predictors of ATTR(18 months)
- presence of ATTR cardiopathy(20 months)
- preoperative predictors of ATTR(18 months)