Quantification of Intraventricular Stasis and Thromboembolic Risk With New Imaging Methods in Patients With Non Ischemic Dilated Myocardiopathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Prevalence of the combined binary variable consisting of left ventricular mural thrombosis or silent brain infarct detected by magnetic resonance imaging
研究概览
简要总结
This study is designed to quantify the ventricular stasis in patients with non-ischemic dilated cardiomyopathy by post-processing of 2D color Doppler echocardiography 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 determined by magnetic resonance.
详细描述
In patients with left ventricular dysfunction, intraventricular mural thrombosis is a recognized risk factor for cardioembolic events. The flow stasis accompanying ventricular remodeling and myocardial dysfunction could favor the formation of small intracavitary thrombi between LV trabeculae, small enough not be detected by conventional imaging techniques. Computational post-processing techniques allow a robust and complete characterization of numerous aspects of fluid dynamics within the heart using the flow field obtained by Echo or MRI imaging, and it is possible to quantify the stasis and washing of blood in the left ventricular cavity.
A cross-sectional study in 80 patients with non-ischemic DCM in sinus rhythm is proposed in which 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 images in order to establish the relationship between quantifiable intraventricular stasis variables and the prevalence of silent and embolic events and intracavitary thrombosis determined by magnetic resonance (MRI).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of nonischemic dilated cardiomyopathy.
- •Sinus rhythm.
- •LV ejection fraction (EF) less than 45%.
- •Signature of informed consent for the study.
排除标准
- •Implantable defibrillation or stimulation devices not compatible with MRI.
- •Hemodynamically significant primary valvular disease or cardiac valve prosthesis.
- •Claustrophobia.
- •Documented history of paroxysmal or persistent atrial fibrillation (AF).
- •Previous carotid disease diagnosed with stenosis greater than 50%.
- •Complete oral anticoagulation prior to inclusion in the study or indication of anticoagulation.
- •Known prothrombotic states (active oncological pathology, alteration of the coagulation cascade).
结局指标
主要结局
Prevalence of the combined binary variable consisting of left ventricular mural thrombosis or silent brain infarct detected by magnetic resonance imaging
时间窗: Within 10 days after enrollment
Quantification of the prevalence of the combined binary variable consisting of one of the following: ventricular thrombosis assessed by cardiac magnetic resonance or silent brain infarct detected by brain magnetic resonance.
次要结局
- Cognitive impact of SBIs(Within 10 days after enrollment)
- Silent brain infarcts (SBI)(Within 10 days after enrollment)
- Left ventricle mural thrombosis assessed by cardiac magnetic resonance imaging(Within 10 days after enrollment)
- Neuropsychiatric impact of SBIs(Within 10 days after enrollment)
研究者
Javier Bermejo Thomas
Head of Cardiac Imaging. Principal Investigator.
Hospital General Universitario Gregorio Marañon