Quantifying blood stasis in heart disease patients
Personalizing The Risk Of Stroke And Silent Brain Infarct In Cardiovascular Disease
Hospital General Universitario Gregorio Marañon · NCT04649034
This study is trying to see how blood flow problems in the hearts of patients with different types of heart disease might lead to strokes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 258 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Hospital General Universitario Gregorio Marañon (other) |
| Locations | 3 sites (Barcelona and 2 other locations) |
| Trial ID | NCT04649034 on ClinicalTrials.gov |
What this trial studies
This observational study aims to quantify ventricular stasis in patients with various forms of cardiomyopathy who are at risk of stroke. By utilizing advanced imaging techniques such as 2D color Doppler echocardiography and phase contrast MRI, the study seeks to establish a relationship between intraventricular stasis and the prevalence of silent embolic events and intracardiac thrombosis. A total of 258 patients will be enrolled, focusing on those with ischemic and non-ischemic dilated cardiomyopathy and hypertrophic cardiomyopathy. The study will involve comprehensive cardiac and cerebral imaging to assess the risk factors associated with stroke.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with specific forms of cardiomyopathy and reduced ejection fraction.
Not a fit: Patients with significant heart valve disease, those with incompatible devices for MRI, or those on full anticoagulation therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved risk assessment and management strategies for patients with cardiomyopathy, potentially reducing the incidence of stroke.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in understanding the relationship between cardiac conditions and stroke risk.
Eligibility criteria
Show full inclusion / exclusion 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...)
Where this trial is running
Barcelona and 2 other locations
- Hospital Clinic de Barcelona — Barcelona, Spain (RECRUITING)
- Hospital General Universitario Gregorio Maranon — Madrid, Spain (RECRUITING)
- Hospital Universitario Clínico de Salamanca — Salamanca, Spain (RECRUITING)
Study contacts
- Principal investigator: Javier Bermejo Thomas, MD, PhD — Hospital General Universitario Gregorio Marañón
- Study coordinator: Javier Bermejo Thomas, MD, PhD
- Email: javier.bermejo@salud.madrid.org
- Phone: (34) 91 5868279
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Dilated Cardiomyopathy, Thrombosis Cardiac, Stroke, Hypertrophic Cardiomyopathy, Dilated cardiomyopathy, Hypertrophic cardiomyopathy, Cardiac thrombosis, Silent brain infarct