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Intraventricular Stasis in Non Ischemic Dilated Myocardiopathy (ISBIDCM)

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ClinicalTrials.gov Identifier: NCT03415789
Recruitment Status : Recruiting
First Posted : January 30, 2018
Last Update Posted : August 23, 2018
Sponsor:
Information provided by (Responsible Party):
Javier Bermejo Thomas, 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.

Condition or disease Intervention/treatment
Dilated Cardiomyopathy Thrombosis Stroke Diagnostic Test: Doppler echocardiogram exam Diagnostic Test: Cardiac Magnetic Resonance Diagnostic Test: Brain Magnetic Resonance Diagnostic Test: Coagulation blood test

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).


Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Quantification of Intraventricular Stasis and Thromboembolic Risk With New Imaging Methods in Patients With Non Ischemic Dilated Myocardiopathy
Actual Study Start Date : February 10, 2018
Estimated Primary Completion Date : December 15, 2019
Estimated Study Completion Date : December 15, 2019


Group/Cohort Intervention/treatment
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.

Diagnostic Test: Doppler echocardiogram exam
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.

Diagnostic Test: Cardiac Magnetic Resonance
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.

Diagnostic Test: Brain Magnetic Resonance
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.

Diagnostic Test: Coagulation blood test
5 ml of peripheral blood will be obtained for assessment of prothrombotic markers at enrollment.




Primary Outcome Measures :
  1. Prevalence of the combined binary variable consisting of left ventricular mural thrombosis or silent brain infarct detected by magnetic resonance imaging [ Time Frame: 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 :
  1. Left ventricle mural thrombosis assessed by cardiac magnetic resonance imaging [ Time Frame: 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.

  2. Silent brain infarcts (SBI) [ Time Frame: 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.

  3. Cognitive impact of SBIs [ Time Frame: 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.


  4. Neuropsychiatric impact of SBIs [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

Inclusion Criteria:

  • Diagnosis of nonischemic dilated cardiomyopathy.
  • Sinus rhythm.
  • LV ejection fraction (EF) less than 45%.
  • Signature of informed consent for the study.

Exclusion Criteria:

  • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03415789


Contacts
Contact: Javier Bermejo Thomas (34) 91 5868279 javier.bermejo@salud.madrid.org

Locations
Spain
Hospital General Universitario Gregorio Maranon Recruiting
Madrid, Spain, 28007
Contact: Javier Bermejo Thomas    (34) 91 5868815    javier.bermejo@salud.madrid.org   
Principal Investigator: Javier Bermejo Thomas, MD, PhD         
Sub-Investigator: Elena Rodríguez González, MD         
Sub-Investigator: Candelas Pérez del Villar, MD, PhD         
Sub-Investigator: Pablo Martínez Legazpi, Eng, PhD         
Sub-Investigator: Ana González Mansilla, MD, PhD         
Sub-Investigator: Esther Pérez David, MD, PhD         
Sub-Investigator: Raquel Yotti Álvarez, MD, PhD         
Sub-Investigator: Irene Méndez Fernández, MD         
Sub-Investigator: Sofía Cuenca Parra, MD, PhD         
Sub-Investigator: Juan Adán Guzmán de Villoria, MD, PhD         
Sub-Investigator: Jesús de la Torre Fernández, MD         
Sub-Investigator: Yolanda Benito, DCS         
Sponsors and Collaborators
Hospital General Universitario Gregorio Marañon
Investigators
Principal Investigator: Javier Bermejo Thomas, MD, PhD Hospital General Universitario Gregorio Marañón

Publications of Results:
Responsible Party: Javier Bermejo Thomas, Head of Cardiac Imaging. Principal Investigator., Hospital General Universitario Gregorio Marañon
ClinicalTrials.gov Identifier: NCT03415789     History of Changes
Other Study ID Numbers: FIBHGM-ISBIDCM
First Posted: January 30, 2018    Key Record Dates
Last Update Posted: August 23, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Javier Bermejo Thomas, Hospital General Universitario Gregorio Marañon:
Non ischemic dilated cardiomyopathy
Cardiac thrombosis
Silent brain infarct
Fluid dynamics
Intracardiac blood flow
Echocardiography

Additional relevant MeSH terms:
Thrombosis
Cardiomyopathies
Cardiomyopathy, Dilated
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Heart Diseases
Cardiomegaly