Clinical trial NCT04649034: Intraventricular Stasis In Cardiovascular Disease
Official title: Personalizing The Risk Of Stroke And Silent Brain Infarct In Cardiovascular Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Dilated Cardiomyopathy
Thrombosis Cardiac
Stroke
Hypertrophic Cardiomyopathy
Keywords: Dilated cardiomyopathy
Hypertrophic cardiomyopathy
Cardiac thrombosis
Silent brain infarct
Stroke
Fluid dynamics
Intracardiac blood flow
Echocardiography
Phase contrast magnetic resonance imaging
Lead sponsor: Hospital General Universitario Gregorio Marañon
Sponsor class: OTHER
Collaborators: name: University of Salamanca
name: Hospital Clinic of Barcelona
First posted: 2020-12-02
Enrollment: 258
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 258 patients with diagnosis of ischemic, non ischemic dilated cardiomyopathy or hypertrophic cardiomyopathy under follow-up in the Cardiology Department of Gregorio Marañón General University Hospital, Madrid, Hospital Universitario Clínico de Salamanca and Hospital Clinic, Barcelona, 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 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).

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...)

Primary outcomes:
measure: Prevalence of a combined binary variable consisting of ventricular thrombosis or silent brain infarct detected by magnetic resonance
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
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon
city: Salamanca
country: Spain
facility: Hospital Universitario Clínico de Salamanca
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.
citation: Delgado-Montero A, Martinez-Legazpi P, Desco MM, Rodriguez-Perez D, Diaz-Otero F, Rossini L, Perez Del Villar C, Rodriguez-Gonzalez E, Chazo C, Benito Y, Flores O, Antoranz JC, Fernandez-Aviles F, Del Alamo JC, Bermejo J. Blood Stasis Imaging Predicts Cerebral Microembolism during Acute Myocardial Infarction. J Am Soc Echocardiogr. 2020 Mar;33(3):389-398. doi: 10.1016/j.echo.2019.09.020. Epub 2019 Dec 5.