Intraventricular Stasis In Cardiovascular Disease

Recruiting

• Conditions: Thrombosis Cardiac; Hypertrophic Cardiomyopathy; Dilated Cardiomyopathy; Stroke

• Registration Number: NCT04649034
• Lead Sponsor: Hospital General Universitario Gregorio Marañon

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 Timeline

• Study Start: 2020-11-24
• Study First Submitted: 2020-11-24
• Study First Submitted QC: 2020-11-24
• Study First Posted: 2020-12-02
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-21
• Last Update Posted: 2023-09-22
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 258

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...)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of a combined binary variable consisting of ventricular thrombosis or silent brain infarct detected by magnetic resonance	Within 10 days after enrollment	The primary outcome measure will be a combined binary variable consisting of one of the following findings: ventricular thrombosis assessed by cardiac magnetic resonance or silent brain infarct detected by brain magnetic resonance

Secondary Outcome Measures

Name	Time	Method
Left ventricle mural thrombosis assessed by cardiac magnetic resonance imaging	Within 10 days after enrollment	Left ventricle mural thrombosis will be assessed by contrast cardiac MRI. Early after gadolinium contrast administration (3 min), two dimensional T1-weighted fast-field-echo sequences with an inversion-recovery prepulse will be used. A long inversion time (520 ms) will be used to identify intraventricular thrombus as a LV mass with low-signal intensity surrounded by high-signal intensity structures.
Silent brain infarcts (SBI)	Within 10 days after enrollment	SBIs diagnosis entails the presence of a focal lesion \> 3 mm that meets one of the three following criteria: 1) high signal on DWI isotropic images and low signal on the map of apparent diffusion coefficient (ADC). DWI sequence allows to detecting ischemic lesions and assessing their chronology. (2) cavitary lesion hyperintense on T2, with no signal (or low) in the FLAIR sequence usually surrounded by a ring gliotic hyperintense, hypointense on T1). (3) hyperintense lesion on T2 / T1 hypointense with prior distribution defect known or new in a follow-up study. The studies will be interpreted by a neuroradiologist blinded to clinical and echocardiographic information. For the assessment of whether the brain infarct is clinically silent, a medical history and physical examination focused on neurological symptoms will be performed including for that purpose the National Institute of Health (USA) questionnaire

Trial Locations

Locations (3)

Hospital Clinic de Barcelona; 🇪🇸 Barcelona, Spain

Hospital General Universitario Gregorio Maranon; 🇪🇸 Madrid, Spain

Hospital Universitario Clínico de Salamanca; 🇪🇸 Salamanca, Spain