Ignite Creation Date:
2025-12-24 @ 10:14 PM
Ignite Modification Date:
2025-12-25 @ 7:49 PM
Study NCT ID:
NCT04657835
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-08
First Post:
2020-11-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessment of Atrial Cardiomyopathy Using MRI as a Predictor of Cardiac Post-Operative Atrial Fibrillation After Cardiac Surgery.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}, {'id': 'D000070536', 'term': 'Independent Medical Evaluation'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 88}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-07', 'studyFirstSubmitDate': '2020-11-24', 'studyFirstSubmitQcDate': '2020-12-01', 'lastUpdatePostDateStruct': {'date': '2025-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Analysis of the occurrence of Post-Operative Atrial Fibrillation', 'timeFrame': '7 days after the surgery', 'description': 'Measured by a continuous recording of cardiac electrical activity during 7 days after the surgery.'}], 'secondaryOutcomes': [{'measure': 'Analysis of the occurrence of Atrial Fibrillation', 'timeFrame': 'Year: 1', 'description': 'Analysis of the occurrence of Atrial Fibrillation evaluated during the first year post-operatively.'}, {'measure': 'Anatomopathological parameters for the evaluation of tissue fibrosis', 'timeFrame': 'Year: 1', 'description': 'Analysis Anatomopathological parameters for the evaluation of tissue fibrosis evaluated by cardiac muscle biopsy.'}, {'measure': 'Assessment of Atrial Heart Disease by cardiac Magnetic Resonance Imaging (MRI) results', 'timeFrame': 'Before the surgery', 'description': 'Assessment of Atrial Heart Disease by cardiac Magnetic Resonance Imaging (MRI) results to find a correlation with Post-Operative Atrial Fibrillation.'}, {'measure': 'Correlation between biological parameter Interleukin 1 (IL-1) and occurrence of Post-Operative Atrial Fibrillation', 'timeFrame': 'Years: 2', 'description': 'Measured by blood sample results.'}, {'measure': 'Correlation between biological parameter TNF-α and occurrence of Post-Operative Atrial Fibrillation', 'timeFrame': 'Years: 2', 'description': 'Measured by blood sample results.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Post Operative Atrial Fibrillation', 'magnetic resonance imaging', 'Coronary Artery Bypass Grafting (CABG)'], 'conditions': ['Coronary Artery Bypass Grafting']}, 'descriptionModule': {'briefSummary': 'After cardiac surgery, there is a high prevalence of postoperative atrial fibrillation (POAF). However, its diagnostic and therapeutic management is poorly codified.\n\nThis pathology is caused by atrial abnormalities which form the concept of atrial cardiomyopathy.\n\nNew tools affording to itemize the atrial cardiomyopathy are needed. Indeed, current tools, as echocardiography and electrocardiogram are relevant but only lead to a raw evaluation of the atrial cardiomyopathy. MRI, because of the assessment of the atrial fibrosis by late gadolinium assessment (LGE) and 4D flow magnetic resonance imaging (MRI) could be relevant to specify the atrial cardiomyopathy.', 'detailedDescription': 'The aim of the study is to evaluate the atrial cardiomyopathy, assessed by magnetic resonance imaging (MRI), as a predictor of postoperative atrial fibrillation (POAF) after with coronary artery bypass graft surgery .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Indication for surgical myocardial revascularization by coronary artery bypass\n* Patient affiliated or entitled to a social security scheme\n* Informed consent for participation in the study\n\nExclusion Criteria:\n\n* Contraindication to cardiac MRI (Severe Kidney disease, Allergy to gadoliniumn, ...)\n* History of Atriale Fibrillation (AF)\n* Indication of cardiac valve surgery concomitantly with Coronary Artery Bypass Grafting (CABG).\n* pregnant or breast-feeding women'}, 'identificationModule': {'nctId': 'NCT04657835', 'acronym': 'IRM-FAPO', 'briefTitle': 'Assessment of Atrial Cardiomyopathy Using MRI as a Predictor of Cardiac Post-Operative Atrial Fibrillation After Cardiac Surgery.', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Saint Etienne'}, 'officialTitle': 'Assessment of Atrial Cardiomyopathy Using MRI as a Predictor of Cardiac Post-Operative Atrial Fibrillation After Cardiac Surgery.', 'orgStudyIdInfo': {'id': '20CH027'}, 'secondaryIdInfos': [{'id': '2020-A01632-37', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Coronary Artery Bypass Grafting', 'description': 'Patient with indication of Coronary Artery Bypass Grafting will be included. They will have:\n\n* before surgery : cardiac Magnetic Resonance Imaging (MRI), Blood sample\n* during surgery : Cardiac muscle biopsy\n* after surgery : Holter-electrocardiogram (ECG), medical examination', 'interventionNames': ['Device: cardiac Magnetic Resonance Imaging (MRI)', 'Biological: Blood sample', 'Procedure: Cardiac muscle biopsy', 'Device: Holter-electrocardiogram (ECG)', 'Other: medical examination']}], 'interventions': [{'name': 'cardiac Magnetic Resonance Imaging (MRI)', 'type': 'DEVICE', 'otherNames': ['4D flow Magnetic Resonance Imaging with Late Gadolinium Enhancement'], 'description': 'Cardiac magnetic resonance imaging (MRI) will be realized before Coronary Artery Bypass Grafting for assess atrial cardiomyopathy.', 'armGroupLabels': ['Coronary Artery Bypass Grafting']}, {'name': 'Blood sample', 'type': 'BIOLOGICAL', 'description': 'Blood sample will be realized (4 tubes of 4ml blood, 16ml in total) before Coronary Artery Bypass Grafting.', 'armGroupLabels': ['Coronary Artery Bypass Grafting']}, {'name': 'Cardiac muscle biopsy', 'type': 'PROCEDURE', 'description': 'Cardiac muscle biopsy will be realized during Coronary Artery Bypass Grafting.', 'armGroupLabels': ['Coronary Artery Bypass Grafting']}, {'name': 'Holter-electrocardiogram (ECG)', 'type': 'DEVICE', 'description': 'Holter-electrocardiogram (ECG) will be realized 1 year after Coronary Artery Bypass Graftin during 3 days to diagnose the occurrence of atrial fibrillation.', 'armGroupLabels': ['Coronary Artery Bypass Grafting']}, {'name': 'medical examination', 'type': 'OTHER', 'description': 'medical examination will be realized 1 year after Coronary Artery Bypass Graftin. Theses datas will collected: events during the follow-up year and evaluation of the Holter-electrocardiogram result.', 'armGroupLabels': ['Coronary Artery Bypass Grafting']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Saint-Etienne', 'country': 'France', 'contacts': [{'name': 'Jean-Baptiste Guichard, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Antoine Da Costa, MD PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Kasra Azarnoush, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'CHU Saint-Etienne', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}], 'centralContacts': [{'name': 'Jean-Baptiste GUICHARD, MD', 'role': 'CONTACT', 'email': 'j.baptiste.guichard@chu-st-etienne.fr', 'phone': '(0)4 77 82 30 77', 'phoneExt': '+33'}, {'name': 'Fleur PETIT, CRA', 'role': 'CONTACT', 'email': 'Fleur.petit@chu-st-etienne.fr', 'phone': '(0)4.77.82.95.58', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Jean-Baptiste GUICHARD, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU SAINT-ETIENNE'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Saint Etienne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}