Intraventricular Stasis in Non Ischemic Dilated Myocardiopathy (ISBIDCM)

Hospital General Universitario Gregorio Marañon

Status: Completed

Conditions: Stroke; Thrombosis; Dilated Cardiomyopathy

Treatments: Diagnostic Test: Doppler echocardiogram exam; Diagnostic Test: Coagulation blood test; Diagnostic Test: Cardiac Magnetic Resonance; Diagnostic Test: Brain Magnetic Resonance

Study type: Observational

Funder types: Other

Identifiers

NCT03415789

FIBHGM-ISBIDCM

Details and patient eligibility

About

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.

Full 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).

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

80 participants in 1 patient group

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.

Treatment:

Diagnostic Test: Cardiac Magnetic Resonance

Diagnostic Test: Brain Magnetic Resonance

Diagnostic Test: Doppler echocardiogram exam

Diagnostic Test: Coagulation blood test