Intraventricular Stasis in Non Ischemic Dilated Myocardiopathy
ISBIDCM
Quantification of Intraventricular Stasis and Thromboembolic Risk With New Imaging Methods in Patients With Non Ischemic Dilated Myocardiopathy
1 other identifier
observational
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2018
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 8, 2018
CompletedFirst Posted
Study publicly available on registry
January 30, 2018
CompletedStudy Start
First participant enrolled
February 10, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 23, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 24, 2020
CompletedNovember 25, 2020
November 1, 2020
2.8 years
January 8, 2018
November 24, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Prevalence of the combined binary variable consisting of left ventricular mural thrombosis or silent brain infarct detected by magnetic resonance imaging
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.
Within 10 days after enrollment
Secondary Outcomes (4)
Left ventricle mural thrombosis assessed by cardiac magnetic resonance imaging
Within 10 days after enrollment
Silent brain infarcts (SBI)
Within 10 days after enrollment
Cognitive impact of SBIs
Within 10 days after enrollment
Neuropsychiatric impact of SBIs
Within 10 days after enrollment
Study Arms (1)
80 patients non ischemic DCM
A cohort of 80 patients with nonischemic dilated cardiomyopathy in sinus rhythm with left ventricle ejection fraction (EF) less than 45%. In the first 24 hours after enrollment a coagulation blood test, an electrocardiogram, a Doppler echocardiogram exam and a clinical examination (including neuropsiquiatric evaluation) will be performed. A cardiac magnetic resonance and a brain magnetic resonance will be performed within 10 days after the enrollment.
Interventions
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.
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.
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.
5 ml of peripheral blood will be obtained for assessment of prothrombotic markers at enrollment.
Eligibility Criteria
80 patients with diagnosis of non-ischemic dilated cardiomyopathy under follow-up in the Cardiology Department of Gregorio Marañón General University Hospital, Madrid, who meet all of the inclusion criteria and none of the exclusion criteria will be included.
You may qualify if:
- Diagnosis of nonischemic dilated cardiomyopathy.
- Sinus rhythm.
- LV ejection fraction (EF) less than 45%.
- Signature of informed consent for the study.
You may not qualify if:
- 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%.
- Known prothrombotic states (active oncological pathology, alteration of the coagulation cascade).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital General Universitario Gregorio Maranon
Madrid, 28007, Spain
Related Publications (4)
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 Physiol Heart Circ Physiol. 2014 Mar 1;306(5):H718-29. doi: 10.1152/ajpheart.00697.2013. Epub 2014 Jan 10.
PMID: 24414062RESULTRossini 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 method for mapping and quantifying blood stasis in the left ventricle. J Biomech. 2016 Jul 26;49(11):2152-2161. doi: 10.1016/j.jbiomech.2015.11.049. Epub 2015 Nov 30.
PMID: 26680013RESULTVermeer 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.
PMID: 17582361RESULTMartinez-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 Infarction. JACC Cardiovasc Imaging. 2018 Mar;11(3):514-515. doi: 10.1016/j.jcmg.2017.06.012. Epub 2017 Oct 5. No abstract available.
PMID: 28917683RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Javier Bermejo Thomas, MD, PhD
Hospital General Universitario Gregorio Marañón
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Cardiac Imaging. Principal Investigator.
Study Record Dates
First Submitted
January 8, 2018
First Posted
January 30, 2018
Study Start
February 10, 2018
Primary Completion
November 23, 2020
Study Completion
November 24, 2020
Last Updated
November 25, 2020
Record last verified: 2020-11