Intraventricular Stasis In Cardiovascular Disease (ISBIFLOW)
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| ClinicalTrials.gov Identifier: NCT04649034 |
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Recruitment Status :
Recruiting
First Posted : December 2, 2020
Last Update Posted : February 4, 2022
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Sponsor:
Hospital General Universitario Gregorio Marañon
Collaborators:
University of Salamanca
Hospital Clinic of Barcelona
Information provided by (Responsible Party):
Javier Bermejo Thomas, Hospital General Universitario Gregorio Marañon
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Brief Summary:
This study is designed to quantify the ventricular stasis in patients with different forms of cardiomyopathy and at risk of stroke (ischemic, non-ischemic dilated cardiomyopathy and hypertrophic cardiomyopathy) by post-processing of 2D color Doppler echocardiography and phase contrast-magnetic resonance 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.
| Condition or disease | Intervention/treatment |
|---|---|
| Dilated Cardiomyopathy Thrombosis Cardiac Stroke Hypertrophic Cardiomyopathy | Diagnostic Test: Doppler echocardiogram exam Diagnostic Test: Cardiac magnetic resonance Diagnostic Test: Brain magnetic resonance Diagnostic Test: Coagulation blood test Diagnostic Test: Holter monitoring |
Cardioembolic stroke is a major source of mortality and disability worldwide and blood stasis inside the heart is the main risk factor for developing intracardiac thrombosis. We have recently developed and patented a quantitative image-based method to map blood stasis within the cardiac chambers. The method is suitable for any medical imaging modality that provides time-resolved flow maps inside the heart (magnetic resonance, echocardiography, or computational-fluid-dynamic processing from anatomical CT images). The objective of the present project is to validate this certified technology in a multicentric cross-sectional clinical trial of 258 patients with different forms of cardiomyopathy with high-risk of stroke.
We will include patients with ischemic, non-ischemic dilated cardiomyopathy and hypertrophic cardiomyopathy in sinus rhythm and 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 and phase contrast-magnetic resonance images in order to establish the relationship between quantifiable intraventricular stasis variables and the prevalence of silent brain infarctions (SBIs) and intracavitary thrombosis determined by magnetic resonance (MRI).
| Study Type : | Observational |
| Estimated Enrollment : | 258 participants |
| Observational Model: | Case-Control |
| Time Perspective: | Cross-Sectional |
| Official Title: | Personalizing The Risk Of Stroke And Silent Brain Infarct In Cardiovascular Disease |
| Actual Study Start Date : | November 24, 2020 |
| Estimated Primary Completion Date : | December 31, 2022 |
| Estimated Study Completion Date : | December 31, 2022 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Familial hypertrophic cardiomyopathy
Familial dilated cardiomyopathy
X-linked dilated cardiomyopathy
| Group/Cohort | Intervention/treatment |
|---|---|
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86 patients ischemic DCM
A cohort of 86 patients with ischemic dilated cardiomyopathy in sinus rhythm and ejection fraction (EF) of LV less than 45%
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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. Diagnostic Test: Holter monitoring At inclusion all patients will carry a Holter device for 24 hours to ensure absence of atrial fibrillation |
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86 patients non ischemic DCM
A cohort of 86 patients with non-ischemic dilated cardiomyopathy in sinus rhythm and ejection fraction (EF) of LV less than 45%
|
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. Diagnostic Test: Holter monitoring At inclusion all patients will carry a Holter device for 24 hours to ensure absence of atrial fibrillation |
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86 patients hypertrophic cardiomyopathy
A cohort of 86 patients with hypertrophic cardiomyopathy in sinus rhythm and ejection fraction (EF) of LV less than 55% or with an apical aneurism diagnosed in an image test
|
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. Diagnostic Test: Holter monitoring At inclusion all patients will carry a Holter device for 24 hours to ensure absence of atrial fibrillation |
Primary Outcome Measures :
- Prevalence of a combined binary variable consisting of ventricular thrombosis or silent brain infarct detected by magnetic resonance [ Time Frame: Within 10 days after enrollment ]The primary outcome measure will be a combined binary variable consisting of one of the following findings: ventricular thrombosis assessed by cardiac magnetic resonance or silent brain infarct detected by brain magnetic resonance
Secondary Outcome Measures :
- 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.
- 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 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
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 100 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
258 patients with diagnosis of ischemic, non ischemic dilated cardiomyopathy or hypertrophic cardiomyopathy under follow-up in the Cardiology Department of Gregorio Marañón General University Hospital, Madrid, Hospital Universitario Clínico de Salamanca and Hospital Clinic, Barcelona, who meet all of the inclusion criteria and none of the exclusion criteria will be included.
Criteria
Inclusion Criteria:
- Patients over 18 years of age.
- Sinus rhythm.
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Meet one of the following criteria:
- Diagnosis of non ischemic DCM and ejection fraction (EF) of LV less than 45%
- Diagnosis of ischemic DCM and ejection fraction (EF) of LV less than 45%
- Diagnosis of hypertrofic myocardiophathy and ejection fraction (EF) of LV less than 55% or apical aneurism diagnosed in an image test.
Exclusion Criteria:
- Implantable defibrillation or stimulation devices not compatible with MRI.
- Hemodinamically significant heart valve disease or prosthetic heart valves.
- Claustrophobia.
- Persistent of paroxysmal atrial fibrillation (AF).
- Prior history of significant carotid disease with stenosis greater than 50%.
- Full anticoagulation therapy prior to admission or indication of anticoagulation.
- Pro-thrombotic disorders (active oncology disease, coagulation disorders…)
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): NCT04649034
Contacts
| Contact: Javier Bermejo Thomas, MD, PhD | (34) 91 5868279 | javier.bermejo@salud.madrid.org |
Locations
| Spain | |
| Hospital Clinic de Barcelona | Recruiting |
| Barcelona, Spain, 08036 | |
| Contact: María Sitges | |
| Sub-Investigator: María Mimbrero | |
| Hospital General Universitario Gregorio Maranon | Recruiting |
| Madrid, Spain, 28007 | |
| Contact: Javier Bermejo Thomas (34) 91 5868815 javier.bermejo@salud.madrid.org | |
| Sub-Investigator: Elena Rodríguez González, MD | |
| Sub-Investigator: Candelas Pérez del Villar, MD, PhD | |
| Sub-Investigator: Pablo Martínez Legapzi, Eng, PhD | |
| Sub-Investigator: Teresa Mombiela, MD | |
| Sub-Investigator: Christian Chazo, Eng | |
| Sub-Investigator: Jesús de la Torre, MD | |
| Hospital Universitario Clínico de Salamanca | Recruiting |
| Salamanca, Spain, 37007 | |
| Contact: Pedro Luis Sánchez | |
| Sub-Investigator: Eduardo Villacorta | |
| Sub-Investigator: María Gallego | |
| Sub-Investigator: Manuel Barreiro | |
Sponsors and Collaborators
Hospital General Universitario Gregorio Marañon
University of Salamanca
Hospital Clinic of Barcelona
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: | NCT04649034 |
| Other Study ID Numbers: |
FIBHGM-ISBIFLOW |
| First Posted: | December 2, 2020 Key Record Dates |
| Last Update Posted: | February 4, 2022 |
| Last Verified: | February 2022 |
| 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:
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Dilated cardiomyopathy Hypertrophic cardiomyopathy Cardiac thrombosis Silent brain infarct Stroke |
Fluid dynamics Intracardiac blood flow Echocardiography Phase contrast magnetic resonance imaging |
Additional relevant MeSH terms:
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Stroke Cardiovascular Diseases Thrombosis Cardiomyopathies Cardiomyopathy, Hypertrophic Cardiomyopathy, Dilated Hypertrophy Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Vascular Diseases Embolism and Thrombosis Heart Diseases Pathological Conditions, Anatomical Aortic Stenosis, Subvalvular Aortic Valve Stenosis Aortic Valve Disease Heart Valve Diseases Cardiomegaly Laminopathies Genetic Diseases, Inborn |