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Completed

NCT Number: NCT03415789

Intraventricular Stasis in Non Ischemic Dilated Myocardiopathy

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.

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Key information

Conditions

Dilated Cardiomyopathy Brain Diseases Cardiomegaly Cardiomyopathies Cardiomyopathy, Dilated Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Embolism and Thrombosis Genetic Diseases, Inborn Heart Diseases Laminopathies Nervous System Diseases Stroke Thrombosis Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital General Universitario Gregorio Maranon

Madrid, 28007, Spain

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Doppler echocardiogram exam

Diagnostic Test

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.

Cardiac magnetic resonance

Diagnostic Test

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.

Brain Magnetic Resonance

Diagnostic Test

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.

Coagulation blood test

Diagnostic Test

5 ml of peripheral blood will be obtained for assessment of prothrombotic markers at enrollment.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Hospital General Universitario Gregorio Marañon

Other

Registry information

Official study title

Quantification of Intraventricular Stasis and Thromboembolic Risk With New Imaging Methods in Patients With Non Ischemic Dilated Myocardiopathy

Acronym: ISBIDCM

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jan 30, 2018
Registry last updated
Nov 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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