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Personalizing The Risk Of Stroke And Silent Brain Infarct In Cardiovascular Disease
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.
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).
Age
18 - 100 years
Sex
ALL
Healthy Volunteers
No
Hospital Clinic de Barcelona
Barcelona, Spain
Hospital General Universitario Gregorio Maranon
Madrid, Spain
Hospital Universitario Clínico de Salamanca
Salamanca, Spain
Start Date
November 24, 2020
Primary Completion Date
December 31, 2024
Completion Date
December 31, 2024
Last Updated
September 15, 2025
258
ACTUAL participants
Doppler echocardiogram exam
DIAGNOSTIC_TEST
Cardiac magnetic resonance
DIAGNOSTIC_TEST
Brain magnetic resonance
DIAGNOSTIC_TEST
Coagulation blood test
DIAGNOSTIC_TEST
Holter monitoring
DIAGNOSTIC_TEST
Lead Sponsor
Hospital General Universitario Gregorio Marañon
Collaborators
NCT07371455
NCT05093673
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT06258538