Personalizing The Risk Of Stroke And Silent Brain Infarct In Cardiovascular Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 258
- 试验地点
- 3
- 主要终点
- Prevalence of a combined binary variable consisting of ventricular thrombosis or silent brain infarct detected by magnetic resonance
研究概览
简要总结
This study is designed to quantify the ventricular stasis in patients with different forms of cardiomyopathy and at risk of stroke (ischemic, non-ischemic dilated cardiomyopathy and hypertrophic cardiomyopathy) by post-processing of 2D color Doppler echocardiography and phase contrast-magnetic resonance images in order to establish the relationship between quantitative variables of intraventricular stasis and the prevalence of silent embolic events and/or intraventricular mural thrombosis.
详细描述
Cardioembolic stroke is a major source of mortality and disability worldwide and blood stasis inside the heart is the main risk factor for developing intracardiac thrombosis. We have recently developed and patented a quantitative image-based method to map blood stasis within the cardiac chambers. The method is suitable for any medical imaging modality that provides time-resolved flow maps inside the heart (magnetic resonance, echocardiography, or computational-fluid-dynamic processing from anatomical CT images). The objective of the present project is to validate this certified technology in a multicentric cross-sectional clinical trial of 258 patients with different forms of cardiomyopathy with high-risk of stroke.
We will include patients with ischemic, non-ischemic dilated cardiomyopathy and hypertrophic cardiomyopathy in sinus rhythm and an echocardiogram, cardiac and cerebral MRI will be performed. Our objective is to quantify the ventricular stasis by post-processing of 2D color Doppler echocardiography and phase contrast-magnetic resonance images in order to establish the relationship between quantifiable intraventricular stasis variables and the prevalence of silent brain infarctions (SBIs) and intracavitary thrombosis determined by magnetic resonance (MRI).
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
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years of age.
- •Sinus rhythm.
- •Meet one of the following criteria:
- •Diagnosis of non ischemic DCM and ejection fraction (EF) of LV less than 45%
- •Diagnosis of ischemic DCM and ejection fraction (EF) of LV less than 45%
- •Diagnosis of hypertrofic myocardiophathy and ejection fraction (EF) of LV less than 55% or apical aneurism diagnosed in an image test.
排除标准
- •Implantable defibrillation or stimulation devices not compatible with MRI.
- •Hemodinamically significant heart valve disease or prosthetic heart valves.
- •Claustrophobia.
- •Persistent of paroxysmal atrial fibrillation (AF).
- •Prior history of significant carotid disease with stenosis greater than 50%.
- •Full anticoagulation therapy prior to admission or indication of anticoagulation.
- •Pro-thrombotic disorders (active oncology disease, coagulation disorders…)
结局指标
主要结局
Prevalence of a combined binary variable consisting of ventricular thrombosis or silent brain infarct detected by magnetic resonance
时间窗: Within 10 days after enrollment
The primary outcome measure will be a combined binary variable consisting of one of the following findings: ventricular thrombosis assessed by cardiac magnetic resonance or silent brain infarct detected by brain magnetic resonance
次要结局
- Left ventricle mural thrombosis assessed by cardiac magnetic resonance imaging(Within 10 days after enrollment)
- Silent brain infarcts (SBI)(Within 10 days after enrollment)
研究者
Javier Bermejo Thomas
Head of Cardiac Imaging. Principal Investigator.
Hospital General Universitario Gregorio Marañon