ISBIDCM
Quantification of Intraventricular Stasis and Thromboembolic Risk With New Imaging Methods in Patients With Non Ischemic Dilated Myocardiopathy
Sponsor study identifier
observational
80
1 country
1
Study Start
February 10, 2018
Actual (reported)Primary Completion
November 23, 2020
Actual (reported)Study Completion
November 24, 2020
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 24, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 8, 2018
Actual (reported)January 30, 2018
Actual (reported)February 10, 2018
Actual (reported)November 23, 2020
Actual (reported)November 24, 2020
Actual (reported)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
Left ventricle mural thrombosis assessed by cardiac magnetic resonance imaging
Within 10 days after enrollment
Silent brain infarcts (SBI)
Within 10 days after enrollment
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.
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.
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.
Hospital General Universitario Gregorio Maranon
Madrid, 28007, 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 Physiol Heart Circ Physiol. 2014 Mar 1;306(5):H718-29. doi: 10.1152/ajpheart.00697.2013. Epub 2014 Jan 10.
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 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.
Javier Bermejo Thomas, MD, PhD
Hospital General Universitario Gregorio Marañon
80 participants (actual enrollment reported by the registry).
First Submitted
January 8, 2018
First Posted
January 30, 2018
Study Start
February 10, 2018
Actual (reported)Dry Needling for Shoulder Pain in Stroke Patients
Cognitive impact of SBIs
Within 10 days after enrollment
Neuropsychiatric impact of SBIs
Within 10 days after enrollment
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
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.
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 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.
Primary Completion
November 23, 2020
Actual (reported)Study Completion
November 24, 2020
Actual (reported)Last Updated
November 25, 2020
Record last verified: 2020-11
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: