NCT04649034

Intraventricular Stasis In Cardiovascular Disease

Personalizing The Risk Of Stroke And Silent Brain Infarct In Cardiovascular Disease

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 258 (actual)
• Sponsor: Hospital General Universitario Gregorio Marañon · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Dilated Cardiomyopathy
• Thrombosis Cardiac
• Stroke
• Hypertrophic Cardiomyopathy

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Doppler echocardiogram exam	A complete echocardiographic study will be performed at enrollment. The echocardiographic images will be acquired as clinically recommended. The protocol will include the acquisition of 1) 2D images in parasternal axis long and short axis; 2) 2D and Doppler tissue images in the apical planes of 4, 2 and 3 chambers; 3) Pulsed, continuous and color Doppler M (DCMM) of transmitral LV flow and LV ejection; 4) 3-Chamber apical plane with and without color Doppler; and 5) 3D LV images. DCMM images will be obtained from the apical window using 4 and 5 chamber planes. Blood flow velocity will be obtained using Color and Gray mode in the 3 chamber view during 5-10 beats in apnea.
DIAGNOSTIC_TEST	Cardiac magnetic resonance	A cardiac MR will be acquired within 10 days after the enrollment. The protocol includes the following sequences: cine mode of short axis from LV base to apex and 2-3-4 chambers. 3D sequence of late enhancement of inversion-recovery. Images will be acquired after 3 min and 10 min of the administration of a total of 0.2 mmol / kg of Prohance®. Intraventricular thrombosis will be monitored. Phase contrast sequences in three orthogonal planes will be acquired. Morphological parameters of LV function (LVEF), contractility ("Wall Motion Score ") and sphericity index will be measured.
DIAGNOSTIC_TEST	Brain magnetic resonance	A brain MR will be acquired within 10 days after the enrollment. Axial, sagittal and coronal spin echo sequence in T1, axial images in diffusion sequences (DWI), enhanced spin echo T2 and FLAIR (fluid-attenuated inversion recovery) sequences shall be obtained. A cerebral infarction will be positive when finding the presence of a focal lesion of\> 3 mm in diameter that meets one of these three characteristics: (1) high signal on isotropic DWI images and low signal on the apparent coefficient map Broadcast (ADC). (2) Cavitary lesion hyperintense on T2, with no signal (or low) in the FLAIR sequence. (3) Hyperintense lesion T2 / T1 hypointense with prior distribution defect known or new in a follow-up study.
DIAGNOSTIC_TEST	Coagulation blood test	5 ml of peripheral blood will be obtained for assessment of prothrombotic markers at enrollment.
DIAGNOSTIC_TEST	Holter monitoring	At inclusion all patients will carry a Holter device for 24 hours to ensure absence of atrial fibrillation

Timeline

• Start date: 2020-11-24
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2020-12-02
• Last updated: 2025-09-15

Locations

3 sites across 1 country: Spain