Early Echographic Screening of Cardiac Amyloidosis Using Red Flag Signals
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 424
- 试验地点
- 2
- 主要终点
- Frequency of cardiac amyloidosis diagnosed according to Gillmore's algorithm
研究概览
简要总结
Cardiac amyloidosis is an increasingly contributor of degenerative cardiac diseases. However, its frequency remains underestimated, and diagnosis is often realized at late stages of the disease. A larger use of clinical and echographic Red Flag signals during routine echocardiographic examination may enhance the identification of early stage of the disease.
详细描述
The objective is to evaluate the clinical and epidemiological aspects of cardiac amyloidosis using a systematic screening of even moderate left ventricular hypertrophy, taking into account the presence of Red Flag signals. Red Flag Signals will include history or symptoms of carpal tunnel syndrome, hearing loss, chronic gastrointestinal disorders, heart failure, cervical or lumbar stenosis, or echographic abnormalities such as apical sparring, increased left ventricular filling pressure, atrio-ventricular block.
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
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of left ventricular hypertrophy defined by a parietal thickness (interventricular septum or posterior wall) ≥ 12 mm on the echocardiogram
- •Age equal or greater than 45 years
- •Current residency in Martinique, Guadeloupe or French Guyana
- •Ability to receive and understand research information
- •Ability to freely deliver informed written consent
排除标准
- •Pregnant or breastfeeding woman
- •Severe uncontrolled hypertension
- •Chronic hemodialysis
- •Person under legal protection measures (guardianship, curatorship, safeguard of justice), and person deprived of liberty
结局指标
主要结局
Frequency of cardiac amyloidosis diagnosed according to Gillmore's algorithm
时间窗: 3 months
frequency of cardiac amyloidosis diagnosed according to Gillmore's algorithm at the end of the diagnosis procedures, using biological (presence of cell dyscrasia), imaging (myocardial staining of bone tracers), and tissue examination (Congo Red staining) variables
次要结局
- Diagnosis value of any Red Flag signal.(5 months)
- Frequency genotype of Transthyretin cardiac amyloidosis according to Gillmore's algorithm(5 months)
- Distribution of Red Flag signals according to Transthyretin genotype(5 months)
- Elaboration of a pre-test probability score(5 months)