Ignite Creation Date:
2025-12-24 @ 5:59 PM
Ignite Modification Date:
2025-12-25 @ 3:21 PM
Study NCT ID:
NCT03542968
Status:
UNKNOWN
Last Update Posted:
2020-01-23
First Post:
2018-05-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Imaging by 4 DFlow in Patients With Tetralogy of Fallot
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D013771', 'term': 'Tetralogy of Fallot'}], 'ancestors': [{'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}], 'ancestors': [{'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-10-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2020-04-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-01-21', 'studyFirstSubmitDate': '2018-05-04', 'studyFirstSubmitQcDate': '2018-05-30', 'lastUpdatePostDateStruct': {'date': '2020-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of the pulmonary artery regurgitation using 2D MRI and 4D Flow MRI.', 'timeFrame': '20 min', 'description': 'Assessment of the pulmonary artery regurgitation using 2D MRI and 4D Flow MRI : regurgitation volume (ml) and regurgitation fraction (%).'}], 'secondaryOutcomes': [{'measure': 'Compare the evaluation of right ventricle volumes using 2D MRI and 4D Flow MRI.', 'timeFrame': '20 min', 'description': 'Assessment of the end-diastolic and end-systolic right ventricle volumes using 2D MRI and 4D Flow MRI (ml).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Congenital heart disease', 'Tetralogy of Fallot', 'Imaging by 4D Flow,', 'Magnetic resonance imaging', 'Prevention of ventricular dysfunction'], 'conditions': ['Congenital Heart Disease']}, 'descriptionModule': {'briefSummary': 'Conventionnal cadiac magnetic resonance (CMR) is the reference to assess changes in right heart flow and pulmonary artery hemodynamics in patients with repaired Tetralogy of Fallot.\n\n4D Flow CMR Imaging is a new imaging modality able to assess all of these parameters faster (8 min vs 30 min) and more comfortably.\n\nThe aim of this study is to compare conventionnal CMR and 4D Flow CMR for the assessment of these parameters (ventricular volume, ventricular systolic function, and regurgitation of the pulmonary pathway).', 'detailedDescription': 'Congenital heart disease, or corrected heart disease requires regular, specialized follow-up throughout the life of these patients. Among the recommended examinations, cardiac MRI is the reference for functionnal ventricles assessment (volume/systolic function), particularly for the right ventricle.\n\nAmong these pathologies, the tetralogy of Fallot is indicative of the increasing importance of cardiac MRI. In this disease, strong parameters has been identifies for the follow to prevent right ventricle dysfunction and ventricular arrhythmias. They rely on right ventricle volumes and on the pulmonary artery regurgitation, both using cardiac MRI.\n\nHowever, this imaging modality imposes constraints such as a long acquisition times (30 to 40 min) or the need to hold apneas, which may render the procedure uncomfortable, even more in the case of very young patients.\n\nThe idea of exploring a new imaging modality is therefore based on the willingness to offer a faster and more comfortable examination. 4D Flow MRI could enable conventionnal parameters, detection of both normal and abnormal right heart flow patterns, and may allow comprehensive analysis of post-surgically altered geometries and hemodynamics.\n\n4D Flow MRI cardiac imaging is :\n\n* A single and faster acquisition (8 to 15 minutes) that cardiac MRI.\n* A free breathing acquisition Imaging modality.\n* A quite-isotropic assessment.\n* A technically simple exam (a single sequence requiring low competence).\n* And offers unlimited post processing.\n\nThe investigators hypothesize that 4D MRI is non-inferior to 2D MRI in patients with corrected tetralogy of Fallot, for the evaluation of conventional cardiac evaluation parameters: ventricular volume, ventricular systolic function, and regurgitation of the pulmonary pathway.\n\nThe investigators hypothesize that 4D MRI is superior to 2D MRI in patients with corrected tetralogy of Fallot, as ti allows to identifying new predictors of ventricular dysfunction such as intravenous extracardiac turbulent / laminar flow character, preferential orientation, flow distribution and trans-tricuspid diastolic flow.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\- children from the age of 10 and above without any upper age limit;\n* giving their informed consent for the study;\n* with a corrected tetralogy of Fallot;\n* sent for a follow-up imaging examination with endomyocardial fibrosis screening;\n\nExclusion Criteria:\n\n* \\- pregnant woman;\n* children \\<10 years old;\n* All contraindications inherent to MRI: (claustrophobia, ferromagnetic intracorporeal foreign bodies)\n* Contraindication to contrast media injection (Gadolinium)'}, 'identificationModule': {'nctId': 'NCT03542968', 'acronym': '4DFlowFallot', 'briefTitle': 'Imaging by 4 DFlow in Patients With Tetralogy of Fallot', 'organization': {'class': 'OTHER', 'fullName': 'Centre Chirurgical Marie Lannelongue'}, 'officialTitle': 'Imaging by 4 DFlow in Patients With Tetralogy of Fallot', 'orgStudyIdInfo': {'id': '2017-A01482-51'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '4D magnetic resonance imaging', 'description': 'MRI, 4D imaging, acquisition and analysis of 4D cardiac MRI images-A single, faster acquisition (8 to 15 minutes).', 'interventionNames': ['Procedure: magnetic resonance imaging']}, {'type': 'SHAM_COMPARATOR', 'label': '2D magnetic resonance imaging', 'description': 'MRI, 2D imaging, acquisition and analysis of 2D cardiac MRI', 'interventionNames': ['Procedure: magnetic resonance imaging']}], 'interventions': [{'name': 'magnetic resonance imaging', 'type': 'PROCEDURE', 'description': 'Acquisition 4D Flow magnetic resonance Imaging-8 minutes', 'armGroupLabels': ['2D magnetic resonance imaging', '4D magnetic resonance imaging']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92350', 'city': 'Le Plessis-Robinson', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Marc antoine ISORNI', 'role': 'CONTACT', 'email': 'ma-isorni@hml.fr', 'phone': '+33140948554'}], 'facility': 'Hôpital Marie Lannelongue', 'geoPoint': {'lat': 48.78889, 'lon': 2.27078}}], 'centralContacts': [{'name': 'Olaf Mercier, Professor', 'role': 'CONTACT', 'email': 'o.mercier@hml.fr', 'phone': '+33140948695'}], 'overallOfficials': [{'name': 'Marc Antoine ISORNI, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpital Marie Lannelongue'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Chirurgical Marie Lannelongue', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}