A National Survey of Prevalence and Accuracy of Echocardiographic Red Flags of Amyloid Cardiomyopathy in Consecutive Patients Undergoing Routine Echocardiography.
试验速览
- 阶段
- 不适用
- 入组人数
- 381
- 试验地点
- 16
- 主要终点
- The prevalence of Amyloid Cardiomyopathy
研究概览
简要总结
This study will investigate the prevalence of echocardiographic red-flags of amyloid cardiomyopathy (AC) in patients undergoing clinically-indicated echocardiography (observational phase) and the prevalence of AC among AC-suggestive echocardiograms (interventional phase).
详细描述
Prospective multicenter Italian survey consisting of two phases: observational (echocardiographic screening for amyloid cardiomyopathy among patients ≥ 55 years undergoing clinically-indicated echocardiography) and interventional (specific clinical and instrumental work-up to detect the prevalence of amyloid cardiomyopathy among amyloid cardiomyopathy-suggestive echocardiograms).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 55 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All the following:
- •Interventricular septum thickness ≥ 13 mm in men and ≥ 12 mm in women;
- •Left ventricular ejection fraction ≥ 50%;
- •Indexed end-diastolic left ventricular volume ≤ 85 mL/m
- •At least one of the following criteria:
- •"Granular sparkling" appearance of the myocardium defined granular texture with uniform increased brightness of echo-reflections;
- •Pericardial effusion regardless of severity;
- •Increased interatrial septum thickness (> 5 mm);
- •Restrictive filling pattern (Dec. Time E wave <120 ms or Dec. Time E wave ≤150 ms e E/A ratio ≥2) or increased ventricular filling pressures (E/E'15);
- •Speckle tracking derived global longitudinal strain with apical sparing pattern;
- •Increased thickness (> 5 mm) of mitral and tricuspid valve leaflets.
排除标准
- •Patients aged < 55 years or > 100 years
- •Echocardiography performed due to known or suspected amyloid cardiomyopathy;
- •Echocardiography performed due to known hypertrophic cardiomyopathy or phenocopies;
- •Refuse to sign the informed consent to the study
结局指标
主要结局
The prevalence of Amyloid Cardiomyopathy
时间窗: 3 months
The prevalence of Amyloid Cardiomyopathy in unselected echocardiographic population of patients aged \> 55 years
The prevalence of echocardiographic red flags of Amyloid Cardiomyopathy
时间窗: 6 months
The prevalence of echocardiographic red flags of Amyloid Cardiomyopathy in unselected echocardiographic population of patients aged \> 55 years
The diagnostic accuracy of echocardiographic red flags of Amyloid Cardiomyopathy
时间窗: 6 months
At the end of phase 2 of this study, patients with Amyloid Cardiomyopathy will be diagnosed, thus allowing to measure the diagnostic accuracy of the following echocardiographic red flags of Amyloid Cardiomyopathy: * Restrictive filling pattern (E wave deceleration time \<120 ms or ≤150 ms in presence of E/A ≥2) and/or E/E'≥15; * "Granular sparkling" appearance of the myocardium; * Pericardial effusion of any entity; * Interatrial septum thickness \>0.5 cm measured in subcostal or four-chamber view; * Thickening of the atrio-ventricular (AV) valves (leaflets thickness \>0.5 cm); * Left ventricular "apical sparing" pattern at speckle-tracking echocardiography.
次要结局
- Multiparametric echocardiographic score(6 months)
研究者
Marco Merlo
MD, Associate Professor
University of Trieste