Intraventricular Stasis In Cardiovascular Disease

Brief Title

Intraventricular Stasis In Cardiovascular Disease

Official Title

Personalizing The Risk Of Stroke And Silent Brain Infarct In Cardiovascular Disease

Brief Summary

      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.
    

Detailed 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).
    

Study Type

Observational

Primary Outcome

Prevalence of a combined binary variable consisting of ventricular thrombosis or silent brain infarct detected by magnetic resonance

Secondary Outcome

 Left ventricle mural thrombosis assessed by cardiac magnetic resonance imaging

Condition

Dilated Cardiomyopathy

Intervention

Doppler echocardiogram exam

Study Arms / Comparison 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%

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Diagnostic Test

Estimated Enrollment

258

Start Date

November 24, 2020

Completion Date

December 31, 2021

Primary Completion Date

December 31, 2021

Eligibility Criteria

        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…)
      

Gender

All

Ages

18 Years - 100 Years

Accepts Healthy Volunteers

No

Contacts

Javier Bermejo Thomas, MD, PhD, (34) 91 5868279, [email protected]

Location Countries

Spain

Location Countries

Spain

NCT ID

NCT04649034

Organization ID

FIBHGM-ISBIFLOW

Responsible Party

Principal Investigator

Study Sponsor

Hospital General Universitario Gregorio Marañon

Collaborators

 Hospital Universitario de Salamanca

Study Sponsor

Javier Bermejo Thomas, MD, PhD, Principal Investigator, Hospital General Universitario Gregorio Marañón

Verification Date

November 2020