Imaging for the Evaluation of Transthyretin Cardiac Amyloidosis Prevalence of Patients Over 65 Hospitalized in Cardiology Wards (the IMPACT Study)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 553
- 试验地点
- 2
- 主要终点
- Percentage of patients with a positive bone scintigraphy (perugini score> or = 2) in the absence of AL cardiac amyloidosis.
研究概览
简要总结
Heart failure with preserved ejection and hypertrophic cardiomyopathy are common diseases and often associated with transthyretin cardiac amyloidosis (TTR-CM), especially in elderly people. Nevertheless, research of TTR-CM is recommended in patients with ventricular hypertrophy without other cause such as valvular disease or hypertension. Therefore, the exact prevalence of TTR-CM remains unknown. We aim to determine the prevalence of TTR-CM in patients with ventricular hypertrophy and aged ≥ 60 years old, hospitalized in our cardiology department (CHU de Poitiers) by performing bone scintigraphy and research of AL amyloidosis.
详细描述
Not Provided
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient ≥ 60 years, hospitalised in cardiology wards of the Centre Hospitalier Universitaire of Poitiers
- •Left ventricle hypertrophy on echocardiography
- •Patient able to comply with study procedures
- •Patient legally free and not subject to any custody, guardianship, tutelage or subordination measures
- •Patient having signed an informed consent after clear and fair information on the study
排除标准
- •CardiacTransplant
- •Complex congenital cardiopathies
- •Know diagnosis of amylosis
- •Contra-indication to bony scintigraphy : hypersensitivity to sodium oxidronate or one of its excipients, or to one of the components of radiopharmaceutic marked product ;
- •Subject not able to comply with study procedures
- •Patients not benefiting from a Social Security scheme or not benefiting from it through a third party
- •Persons benefiting from enhanced protection, namely minors, persons deprived of their liberty by a judicial or administrative decision, patients staying in a health or social establishment, adults under legal protection, and patients in emergency situation.
- •Women not menopausal
研究组 & 干预措施
Bony scintigraphy
Bony scintigraphy within 1 to 4 months after inclusion
干预措施: Bony scintigraphy (Procedure)
结局指标
主要结局
Percentage of patients with a positive bone scintigraphy (perugini score> or = 2) in the absence of AL cardiac amyloidosis.
时间窗: At Visit 2, one to four months after inclusion visit.
Percentage of patients with a positive bone scintigraphy (perugini score\> or = 2) in the absence of AL cardiac amyloidosis in patients over 60 years hospitalised in cardiology wards, with an hypertrophy of the left ventricle on transthoracic echocardiography (thickness of the left ventricle at the end of diastole \>12mm), whatever the possible cause of hypertrophy of the left ventricle (other potential cause not excluded), and without prior diagnosis of cardiac amylosis.
次要结局
未报告次要终点