Intraventricular Stasis In Cardiovascular Disease (ISBIFLOW)

Hospital General Universitario Gregorio Marañon

Status: Completed

Conditions: Stroke; Thrombosis Cardiac; Hypertrophic Cardiomyopathy; Dilated Cardiomyopathy

Treatments: Diagnostic Test: Holter monitoring; Diagnostic Test: Doppler echocardiogram exam; Diagnostic Test: Brain magnetic resonance; Diagnostic Test: Coagulation blood test; Diagnostic Test: Cardiac magnetic resonance

Study type: Observational

Funder types: Other

Identifiers

NCT04649034

FIBHGM-ISBIFLOW

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 258 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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…)

Trial design

258 participants in 3 patient groups

86 patients ischemic DCM

Description:

A cohort of 86 patients with ischemic dilated cardiomyopathy in sinus rhythm and ejection fraction (EF) of LV less than 45%

Treatment:

Diagnostic Test: Coagulation blood test

Diagnostic Test: Cardiac magnetic resonance

Diagnostic Test: Brain magnetic resonance

Diagnostic Test: Doppler echocardiogram exam

Diagnostic Test: Holter monitoring

86 patients non ischemic DCM

Description:

A cohort of 86 patients with non-ischemic dilated cardiomyopathy in sinus rhythm and ejection fraction (EF) of LV less than 45%

Treatment:

Diagnostic Test: Coagulation blood test

Diagnostic Test: Cardiac magnetic resonance

Diagnostic Test: Brain magnetic resonance

Diagnostic Test: Doppler echocardiogram exam

Diagnostic Test: Holter monitoring

86 patients hypertrophic cardiomyopathy

Description:

A cohort of 86 patients with hypertrophic cardiomyopathy in sinus rhythm and ejection fraction (EF) of LV less than 55% or with an apical aneurism diagnosed in an image test

Treatment:

Diagnostic Test: Coagulation blood test

Diagnostic Test: Cardiac magnetic resonance

Diagnostic Test: Brain magnetic resonance

Diagnostic Test: Doppler echocardiogram exam

Diagnostic Test: Holter monitoring