Stroke Clinical Trial
— ISBIFLOWOfficial title:
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.
Status | Recruiting |
Enrollment | 258 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | 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…) |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Clinic de Barcelona | Barcelona | |
Spain | Hospital General Universitario Gregorio Maranon | Madrid | |
Spain | Hospital Universitario Clínico de Salamanca | Salamanca |
Lead Sponsor | Collaborator |
---|---|
Hospital General Universitario Gregorio Marañon | Hospital Clinic of Barcelona, University of Salamanca |
Spain,
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 Physio — View 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 Cer — View 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 — View 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 me — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Prevalence of a combined binary variable consisting of ventricular thrombosis or silent brain infarct detected by magnetic resonance | 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 | Within 10 days after enrollment | |
Secondary | Left ventricle mural thrombosis assessed by cardiac magnetic resonance imaging | 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. | Within 10 days after enrollment | |
Secondary | Silent brain infarcts (SBI) | 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 | Within 10 days after enrollment |
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