Brief Title
Intraventricular Stasis in Non Ischemic Dilated Myocardiopathy
Official Title
Quantification of Intraventricular Stasis and Thromboembolic Risk With New Imaging Methods in Patients With Non Ischemic Dilated Myocardiopathy
Brief Summary
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.
Detailed Description
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).
Study Type
Observational
Primary Outcome
Prevalence of the combined binary variable consisting of left ventricular mural thrombosis or silent brain infarct detected by magnetic resonance imaging
Secondary Outcome
Left ventricle mural thrombosis assessed by cardiac magnetic resonance imaging
Condition
Dilated Cardiomyopathy
Intervention
Doppler echocardiogram exam
Study Arms / Comparison Groups
80 patients non ischemic DCM
Description: A cohort of 80 patients with nonischemic dilated cardiomyopathy in sinus rhythm with left ventricle ejection fraction (EF) less than 45%. In the first 24 hours after enrollment a coagulation blood test, an electrocardiogram, a Doppler echocardiogram exam and a clinical examination (including neuropsiquiatric evaluation) will be performed. A cardiac magnetic resonance and a brain magnetic resonance will be performed within 10 days after the enrollment.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Diagnostic Test
Estimated Enrollment
80
Start Date
February 10, 2018
Completion Date
November 24, 2020
Primary Completion Date
November 23, 2020
Eligibility Criteria
Inclusion Criteria: - Diagnosis of nonischemic dilated cardiomyopathy. - Sinus rhythm. - LV ejection fraction (EF) less than 45%. - Signature of informed consent for the study. Exclusion Criteria: - 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).
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Javier Bermejo Thomas, MD, PhD, ,
Location Countries
Spain
Location Countries
Spain
Administrative Informations
NCT ID
NCT03415789
Organization ID
FIBHGM-ISBIDCM
Responsible Party
Principal Investigator
Study Sponsor
Hospital General Universitario Gregorio Marañon
Study Sponsor
Javier Bermejo Thomas, MD, PhD, Principal Investigator, Hospital General Universitario Gregorio Marañón
Verification Date
November 2020