Dilated CardiomyopathyISBIFLOWNCT04649034
Intraventricular Stasis In Cardiovascular Disease
An observational study of Dilated Cardiomyopathy and Thrombosis Cardiac, run by Hospital General Universitario Gregorio Marañon at 3 sites in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Dilated Cardiomyopathy, Thrombosis Cardiac, Stroke
- What is being tested?
- Doppler echocardiogram exam, Cardiac magnetic resonance and Brain magnetic resonance
- How many people
- 258 participants
- Where
- 3 sitesSpain
- Study dates
- 24 Nov 2020to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients over 18 years of age.
- Sinus rhythm.
- 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.
Who cannot join
- 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…)
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Hospital Clinic de Barcelona
Barcelona, 08036
Hospital General Universitario Gregorio Maranon
Madrid, 28007
Hospital Universitario Clínico de Salamanca
Salamanca, 37007
About this study
Official title: Personalizing The Risk Of Stroke And Silent Brain Infarct In Cardiovascular Disease
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.
Read the detailed description
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).
- Being tested
- Doppler echocardiogram exam, Cardiac magnetic resonance, Brain magnetic resonance, Coagulation blood test, Holter monitoring
- Keywords
- Dilated cardiomyopathy, Hypertrophic cardiomyopathy, Cardiac thrombosis, Silent brain infarct, Stroke, Fluid dynamics, Intracardiac blood flow, Echocardiography, Phase contrast magnetic resonance imaging
- Medical subject headings
- Cardiomyopathy, Dilated, Stroke, Cardiomyopathy, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doppler echocardiogram examDiagnostic 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 resonanceDiagnostic 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 resonanceDiagnostic 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 testDiagnostic test
5 ml of peripheral blood will be obtained for assessment of prothrombotic markers at enrollment.
Holter monitoringDiagnostic test
At inclusion all patients will carry a Holter device for 24 hours to ensure absence of atrial fibrillation
| Study group | Role | What they receive |
|---|---|---|
| 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% Receives: Diagnostic Test: Doppler echocardiogram exam; Diagnostic Test: Cardiac magnetic resonance; Diagnostic Test: Brain magnetic resonance; Diagnostic Test: Coagulation blood test; Diagnostic Test: Holter monitoring | |
| 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% Receives: Diagnostic Test: Doppler echocardiogram exam; Diagnostic Test: Cardiac magnetic resonance; Diagnostic Test: Brain magnetic resonance; Diagnostic Test: Coagulation blood test; Diagnostic Test: Holter monitoring | |
| 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 Receives: Diagnostic Test: Doppler echocardiogram exam; Diagnostic Test: Cardiac magnetic resonance; Diagnostic Test: Brain magnetic resonance; Diagnostic Test: Coagulation blood test; Diagnostic Test: Holter monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of a combined binary variable consisting of ventricular thrombosis or silent brain infarct detected by magnetic resonance
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
Measured: Within 10 days after enrollment
Secondary outcomes (2)
Left ventricle mural thrombosis assessed by cardiac magnetic resonance imaging
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.
Measured: Within 10 days after enrollment
Silent brain infarcts (SBI)
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
Measured: Within 10 days after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2020
- Study start24 Nov 2020
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Dilated CardiomyopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 258 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital General Universitario Gregorio Marañon
- Sponsor type
- University, hospital or other
- Collaborators
- University of Salamanca, Hospital Clinic of Barcelona
- Responsible party
- Principal investigator, Javier Bermejo Thomas, Hospital General Universitario Gregorio Marañon
- Investigators
- Javier Bermejo Thomas, MD, PhD, Principal investigator, Hospital General Universitario Gregorio Marañon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04649034
- Sponsor's protocol ID
- FIBHGM-ISBIFLOW
- Acronym
- ISBIFLOW
- Status last verified
- Sep 2025
- First submitted
- 24 Nov 2020
- Last updated
- 15 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 24414062Rossini 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.
PubMed 26680013Vermeer 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.
PubMed 17582361Martinez-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.
PubMed 28917683Delgado-Montero A, Martinez-Legazpi P, Desco MM, Rodriguez-Perez D, Diaz-Otero F, Rossini L, Perez Del Villar C, Rodriguez-Gonzalez E, Chazo C, Benito Y, Flores O, Antoranz JC, Fernandez-Aviles F, Del Alamo JC, Bermejo J. Blood Stasis Imaging Predicts Cerebral Microembolism during Acute Myocardial Infarction. J Am Soc Echocardiogr. 2020 Mar;33(3):389-398. doi: 10.1016/j.echo.2019.09.020. Epub 2019 Dec 5.
PubMed 31813676
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalizing The Risk Of Stroke And Silent Brain Infarct In Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT04649034
- Acronym / sponsor ID
- ISBIFLOW / FIBHGM-ISBIFLOW
- Keywords
- Dilated cardiomyopathy, Hypertrophic cardiomyopathy, Cardiac thrombosis, Silent brain infarct, Stroke, Fluid dynamics, Intracardiac blood flow, Echocardiography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 258 participants (actual)
- Lead sponsor
- Hospital General Universitario Gregorio MarañonUniversity, hospital or other
- Collaborators
- University of Salamanca, Hospital Clinic of Barcelona
- Study start
- 24 Nov 2020 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 2 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 86 patients ischemic DCM | – | Diagnostic Test: Doppler echocardiogram exam, Diagnostic Test: Cardiac magnetic resonance, Diagnostic Test: Brain magnetic resonance, Diagnostic Test: Coagulation blood test, Diagnostic Test: Holter monitoringA cohort of 86 patients with ischemic dilated cardiomyopathy in sinus rhythm and ejection fraction (EF) of LV less than 45% |
| 86 patients non ischemic DCM | – | Diagnostic Test: Doppler echocardiogram exam, Diagnostic Test: Cardiac magnetic resonance, Diagnostic Test: Brain magnetic resonance, Diagnostic Test: Coagulation blood test, Diagnostic Test: Holter monitoringA cohort of 86 patients with non-ischemic dilated cardiomyopathy in sinus rhythm and ejection fraction (EF) of LV less than 45% |
| 86 patients 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 monitoringA 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 |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- Patients over 18 years of age.
- Sinus rhythm.
- Meet one of the following criteria:
Key exclusion criteria (7 listed)
- 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%.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Doppler echocardiogram examA 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 | 86 patients hypertrophic cardiomyopathy, 86 patients ischemic DCM, 86 patients non ischemic DCM |
| Cardiac magnetic resonanceA 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 | 86 patients hypertrophic cardiomyopathy, 86 patients ischemic DCM, 86 patients non ischemic DCM |
| Brain magnetic resonanceA 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 | 86 patients hypertrophic cardiomyopathy, 86 patients ischemic DCM, 86 patients non ischemic DCM |
| Coagulation blood test5 ml of peripheral blood will be obtained for assessment of prothrombotic markers at enrollment. | Diagnostic test | 86 patients hypertrophic cardiomyopathy, 86 patients ischemic DCM, 86 patients non ischemic DCM |
| Holter monitoringAt inclusion all patients will carry a Holter device for 24 hours to ensure absence of atrial fibrillation | Diagnostic test | 86 patients hypertrophic cardiomyopathy, 86 patients ischemic DCM, 86 patients non ischemic DCM |
Primary outcome
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
2 secondary outcomes
Left ventricle mural thrombosis assessed by cardiac magnetic resonance imaging
Time frame: Within 10 days after enrollment
Silent brain infarcts (SBI)
Time frame: Within 10 days after enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Results publication: PubMed 24414062Bermejo 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.
- Results publication: PubMed 26680013Rossini 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.
- Results publication: PubMed 17582361Vermeer 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.
- Results publication: PubMed 28917683Martinez-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.
- Results publication: PubMed 31813676Delgado-Montero A, Martinez-Legazpi P, Desco MM, Rodriguez-Perez D, Diaz-Otero F, Rossini L, Perez Del Villar C, Rodriguez-Gonzalez E, Chazo C, Benito Y, Flores O, Antoranz JC, Fernandez-Aviles F, Del Alamo JC, Bermejo J. Blood Stasis Imaging Predicts Cerebral Microembolism during Acute Myocardial Infarction. J Am Soc Echocardiogr. 2020 Mar;33(3):389-398. doi: 10.1016/j.echo.2019.09.020. Epub 2019 Dec 5.
- Individual participant dataSharing planned: Undecided
Related trials for Dilated Cardiomyopathy
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Active, not recruiting
Microvascular Dysfunction Assessment to Predict Left Ventricular Reverse Remodeling
Heart Failure, Left Ventricular Dysfunction
RecruitingPhase 1/2
An AAV Gene Therapy Trial of AFTX-201 in Adults With BAG3-Associated Dilated Cardiomyopathy (DCM)
Dilated Cardiomyopathy (DCM), BAG3 Mutation Associated Dilated Cardiomyopathy
RecruitingPhase 1/2
Endocardial Delivery for Myocardial Regeneration Using Allogeneic iPSC-derived Cardiomyocyte Spheroids for HF With Systolic Dysfunction (EMERALD Study)
Heart Failure, Ischemic Heart Failure
RecruitingObservational study
Observational Study of Natural History of BAG3 Gene Mutation-Associated Dilated Cardiomyopathy in Chinese Adults
Dilated Cardiomyopathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Javier Bermejo Thomas, MD, PhD principal investigator
Hospital General Universitario Gregorio Marañon
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dilated Cardiomyopathy and Thrombosis Cardiac, run by Hospital General Universitario Gregorio Marañon at 3 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04649034, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.