Intraventricular Stasis in Non Ischemic Dilated Myocardiopathy

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 Status

Diagnostic Test

Estimated Enrollment

80

Start Date

February 10, 2018

Completion Date

December 15, 2020

Primary Completion Date

December 15, 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, (34) 91 5868279, [email protected]

Location Countries

Spain

Location Countries

Spain

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

April 2020