Intraventricular Stasis in Non Ischemic Dilated Myocardiopathy
- Conditions
- ThrombosisDilated CardiomyopathyStroke
- Registration Number
- NCT03415789
- Lead Sponsor
- Hospital General Universitario Gregorio Marañon
- Brief Summary
This study is designed to quantify the ventricular stasis in patients with non-ischemic dilated cardiomyopathy by post-processing of 2D color Doppler echocardiography 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 determined by magnetic resonance.
- Detailed Description
In patients with left ventricular dysfunction, intraventricular mural thrombosis is a recognized risk factor for cardioembolic events. The flow stasis accompanying ventricular remodeling and myocardial dysfunction could favor the formation of small intracavitary thrombi between LV trabeculae, small enough not be detected by conventional imaging techniques. Computational post-processing techniques allow a robust and complete characterization of numerous aspects of fluid dynamics within the heart using the flow field obtained by Echo or MRI imaging, and it is possible to quantify the stasis and washing of blood in the left ventricular cavity.
A cross-sectional study in 80 patients with non-ischemic DCM in sinus rhythm is proposed in which 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 images in order to establish the relationship between quantifiable intraventricular stasis variables and the prevalence of silent and embolic events and intracavitary thrombosis determined by magnetic resonance (MRI).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
- Diagnosis of nonischemic dilated cardiomyopathy.
- Sinus rhythm.
- LV ejection fraction (EF) less than 45%.
- Signature of informed consent for the study.
- Implantable defibrillation or stimulation devices not compatible with MRI.
- Hemodynamically significant primary valvular disease or cardiac valve prosthesis.
- Claustrophobia.
- Documented history of paroxysmal or persistent atrial fibrillation (AF).
- Previous carotid disease diagnosed with stenosis greater than 50%.
- Complete oral anticoagulation prior to inclusion in the study or indication of anticoagulation.
- Known prothrombotic states (active oncological pathology, alteration of the coagulation cascade).
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Prevalence of the combined binary variable consisting of left ventricular mural thrombosis or silent brain infarct detected by magnetic resonance imaging Within 10 days after enrollment Quantification of the prevalence of the combined binary variable consisting of one of the following: ventricular thrombosis assessed by cardiac magnetic resonance or silent brain infarct detected by brain magnetic resonance.
- Secondary Outcome Measures
Name Time Method Cognitive impact of SBIs Within 10 days after enrollment Cognitive impact of SBIs assessed by MMSE. The Mini Mental State Examination (MMSE) is a tool that can be used to systematically and thoroughly assess mental status. It is an 11-question measure that tests five areas of cognitive function: orientation, registration, attention and calculation, recall, and language. The maximum score is 30, and the minimum score is 0. A score of 23 or lower is indicative of cognitive impairment.
The following three cut-off levels are employed to classify the severity of cognitive impairment: no cognitive impairment = 24-30; mild cognitive impairment = 18-23; severe cognitive impairment = 0-17.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 (4 hours) 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.
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.
Neuropsychiatric impact of SBIs Within 10 days after enrollment Neuropsychiatric impact of SBIs assessed by the Beck Depression Inventory. The Beck Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression; each set is ranked in terms of severity and scored from 0 to 3. The maximun score for the whole test is 63 and the lowest is 0. The cut-off scores with patients diagnosed as having an affective disorder are the following: none or minimal depression is \< 10; mild to moderate depression is 10-18; moderate to severe depression is 19-29; and severe depression is 30-63.
Trial Locations
- Locations (1)
Hospital General Universitario Gregorio Maranon
🇪🇸Madrid, Spain
Hospital General Universitario Gregorio Maranon🇪🇸Madrid, Spain