Ignite Creation Date:
2025-12-24 @ 11:15 PM
Ignite Modification Date:
2025-12-25 @ 8:53 PM
Study NCT ID:
NCT05569356
Status:
NOT_YET_RECRUITING
Last Update Posted:
2022-10-13
First Post:
2022-09-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Diagnostic Contribution, Prognosis and Physiopathological Aspects in Arrhythmogenic Cardiomyopathy. (ACORE)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008137', 'term': 'Longitudinal Studies'}, {'id': 'D012189', 'term': 'Retrospective Studies'}], 'ancestors': [{'id': 'D015331', 'term': 'Cohort Studies'}, {'id': 'D016021', 'term': 'Epidemiologic Studies'}, {'id': 'D016020', 'term': 'Epidemiologic Study Characteristics'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'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'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D016022', 'term': 'Case-Control Studies'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Plasma, Serum, PBMC, pericardial fluid, myocarditis biopsy'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-10-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2032-10-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-11', 'studyFirstSubmitDate': '2022-09-14', 'studyFirstSubmitQcDate': '2022-10-03', 'lastUpdatePostDateStruct': {'date': '2022-10-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2032-10-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measure the correlation between the autoimmunity, inflammatory, and immunological profiles through biomarkers found in blood samples, myocardial biopsies, mass imaging cytometry, and cardiac imaging in patients with Arrhythmogenic Cardiomyopathy (AC)', 'timeFrame': '10 years'}], 'secondaryOutcomes': [{'measure': 'Measure the correlation between circulating biomarkers and the severity of the phenotype determined by the severity of AC and multi-modality imaging', 'timeFrame': '10 years'}, {'measure': 'Measure the correlation between imaging biomarkers and electrocardiogram (ECG) parameters (presence of repolarization and depolarization abnormalities)', 'timeFrame': '10 years'}, {'measure': 'Measure the changes in inflammatory biomarkers in serum and cardiac imaging over time', 'timeFrame': '10 years'}, {'measure': 'Demonstrate a correlation between circulating and imaging biomarkers and the link between the extent of fibro-adipose infiltrates and the ventricular strain', 'timeFrame': '10 years'}, {'measure': 'Measure the correlation between circulating and imaging biomarker values and electro-anatomical mapping data', 'timeFrame': '10 years'}, {'measure': 'Screening for cardiotropic virus in pericardial fluid and circulating blood sampled in routine care during epicardial ablation by PCR', 'timeFrame': '10 years'}, {'measure': 'Measure the correlation between the presence of a pathogenic or common genetic variant and serum/imaging biomarkers.', 'timeFrame': '10 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Arrhythmogenic Cardiomyopathy', 'Inflammatory biomarkers', 'Autoantibodies'], 'conditions': ['Arrhythmogenic Cardiomyopathy']}, 'descriptionModule': {'briefSummary': 'This study aims to identify novel inflammatory biomarkers in AC, whether in circulating blood, in situ or as imaging biomarkers to better understand the pathophysiology of the disease and then to determine contribution to the clinical management of patients.', 'detailedDescription': 'The treatment of AC remains based on palliative measures aimed at treating the consequences of the disease: antiarrhythmic treatments, defibrillator, treatments for heart failure. The identification of new biomarkers, in particular circulating ones, would make it possible to open pathophysiology avenues which, in the long term, could lead to therapies targeted to autoimmunity or inflammation.\n\nMany scientific and medical questions remain unanswered and require precise databases on the diagnostic and prognostic evaluation of this pathology.\n\nThe objective of this study is to identify novel inflammatory biomarkers in patients with AC by studying the autoimmunity, inflammatory, and immunological profiles through blood samples and myocardial biopsies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All adult patients with clinical or preclinical Arrhythmogenic Cardiomyopathy (carrier of risk mutation). The retrospective patients will be informed by mail and the prospective patients will be informed during their routine care visit, both using the opt-out approach.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adult patient (age ≥ 18 years old)\n2. Patient with a probable or confirmed diagnosis of cardiomyopathy according to the diagnostic criteria of the international task force\n3. Patient carrying a pathogenic mutation responsible for cardiomyopathy\n4. Patient informed individually of the research\n\nExclusion Criteria:\n\n1. Patients under curatorship/guardianship\n2. Pregnant women\n3. Patients who expressed their opposition to participate in the study'}, 'identificationModule': {'nctId': 'NCT05569356', 'acronym': 'ACORE', 'briefTitle': 'Diagnostic Contribution, Prognosis and Physiopathological Aspects in Arrhythmogenic Cardiomyopathy. (ACORE)', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Biomarkers of Inflammation and Autoimmunity: Diagnostic Contribution, Prognosis and Physiopathological Aspects in Arrhythmogenic Cardiomyopathy.', 'orgStudyIdInfo': {'id': 'APHP210985'}, 'secondaryIdInfos': [{'id': '2022-A00283-40', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Arrhythmogenic Right Ventricular Cardiomyopathy (Prospective)', 'interventionNames': ['Biological: Prospective']}, {'label': 'Arrhythmogenic Right Ventricular Cardiomyopathy (Retrospective)', 'interventionNames': ['Other: Retrospective']}], 'interventions': [{'name': 'Prospective', 'type': 'BIOLOGICAL', 'description': '-Additional blood samples -Myocarditis biopsy sample (routine care) -Additional pericardial fluid sample (routine care)', 'armGroupLabels': ['Arrhythmogenic Right Ventricular Cardiomyopathy (Prospective)']}, {'name': 'Retrospective', 'type': 'OTHER', 'description': 'None (only data collection)', 'armGroupLabels': ['Arrhythmogenic Right Ventricular Cardiomyopathy (Retrospective)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75013', 'city': 'Paris', 'country': 'France', 'facility': 'Institut de Cardiologie de la Pitié-Salpêtrière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Estelle GANDJBAKHCH, Dr', 'role': 'CONTACT', 'email': 'estelle.gandjbakhch@aphp.fr', 'phone': '+33 1 42 16 30 55'}, {'name': 'Mikael LAREDO, Dr', 'role': 'CONTACT', 'email': 'mikael.laredo@aphp.fr'}], 'overallOfficials': [{'name': 'Estelle GANDJBAKHCH, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor', 'ipdSharing': 'YES', 'description': "Data are available upon reasonable request. The procedures carried out with the French data privacy authority (CNIL, Commission Nationale de l'Informatique et des Libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients.\n\nConsultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.", 'accessCriteria': 'Researchers who provide a methodologically sound proposal'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}