Clinical trial NCT03415789: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dilated Cardiomyopathy
Thrombosis
Stroke
Keywords: Non ischemic dilated cardiomyopathy
Cardiac thrombosis
Silent brain infarct
Fluid dynamics
Intracardiac blood flow
Echocardiography
Lead sponsor: Hospital General Universitario Gregorio Marañon
Sponsor class: OTHER
First posted: 2018-01-30
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 80 patients with diagnosis of non-ischemic dilated cardiomyopathy under follow-up in the Cardiology Department of Gregorio Marañón General University Hospital, Madrid, who meet all of the inclusion criteria and none of the exclusion criteria will be included.

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).

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).

Primary outcomes:
measure: Prevalence of the combined binary variable consisting of left ventricular mural thrombosis or silent brain infarct detected by magnetic resonance imaging
timeFrame: Within 10 days after enrollment
Secondary outcomes:
measure: Left ventricle mural thrombosis assessed by cardiac magnetic resonance imaging
timeFrame: Within 10 days after enrollment
measure: Silent brain infarcts (SBI)
timeFrame: Within 10 days after enrollment
measure: Cognitive impact of SBIs
timeFrame: Within 10 days after enrollment
measure: Neuropsychiatric impact of SBIs
timeFrame: Within 10 days after enrollment
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon
Study officials:
affiliation: Hospital General Universitario Gregorio Marañón
name: Javier Bermejo Thomas, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bermejo J, Benito Y, Alhama M, Yotti R, Martinez-Legazpi P, Del Villar CP, Perez-David E, Gonzalez-Mansilla A, Santa-Marta C, Barrio A, Fernandez-Aviles F, Del Alamo JC. Intraventricular vortex properties in nonischemic dilated cardiomyopathy. Am J Physiol Heart Circ Physiol. 2014 Mar 1;306(5):H718-29. doi: 10.1152/ajpheart.00697.2013. Epub 2014 Jan 10.
citation: Rossini L, Martinez-Legazpi P, Vu V, Fernandez-Friera L, Perez Del Villar C, Rodriguez-Lopez S, Benito Y, Borja MG, Pastor-Escuredo D, Yotti R, Ledesma-Carbayo MJ, Kahn AM, Ibanez B, Fernandez-Aviles F, May-Newman K, Bermejo J, Del Alamo JC. A clinical method for mapping and quantifying blood stasis in the left ventricle. J Biomech. 2016 Jul 26;49(11):2152-2161. doi: 10.1016/j.jbiomech.2015.11.049. Epub 2015 Nov 30.
citation: Vermeer SE, Longstreth WT Jr, Koudstaal PJ. Silent brain infarcts: a systematic review. Lancet Neurol. 2007 Jul;6(7):611-9. doi: 10.1016/S1474-4422(07)70170-9.
citation: Martinez-Legazpi P, Rossini L, Perez Del Villar C, Benito Y, Devesa-Cordero C, Yotti R, Delgado-Montero A, Gonzalez-Mansilla A, Kahn AM, Fernandez-Aviles F, Del Alamo JC, Bermejo J. Stasis Mapping Using Ultrasound: A Prospective Study in Acute Myocardial Infarction. JACC Cardiovasc Imaging. 2018 Mar;11(3):514-515. doi: 10.1016/j.jcmg.2017.06.012. Epub 2017 Oct 5. No abstract available.