Ignite Creation Date:
2025-12-26 @ 10:16 PM
Ignite Modification Date:
2025-12-26 @ 10:16 PM
Study NCT ID:
NCT04344912
Status:
RECRUITING
Last Update Posted:
2024-10-15
First Post:
2020-04-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of COVID19 Outbreak in Cardiac Acute Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054058', 'term': 'Acute Coronary Syndrome'}, {'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003625', 'term': 'Data Collection'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-11', 'studyFirstSubmitDate': '2020-04-10', 'studyFirstSubmitQcDate': '2020-04-10', 'lastUpdatePostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of recurrent Major Cardiovascular Events (MACE) and urgent rehospitalization', 'timeFrame': 'From admission to one year follow up'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID19', 'Acute Coronary Syndrome', 'Myocardial Infarction'], 'conditions': ['Acute Coronary Syndrome', 'Heart Failure', 'COVID']}, 'descriptionModule': {'briefSummary': 'This registry will evaluate the impact of the COVID19 outbreak on Cardiac patients admitted in the Intensive Care Unit of the Pitie-Salpetriere Hospital in Paris, France', 'detailedDescription': 'Registry on Characteristics and outcomes of Cardiac patients (COVID- and COVID+) hospitalized in the Intensive Care Unit of the Pitie-Salpetriere Hospital in Paris, France'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients treated in the CCU at Cardiology Institute of the Pitié-Salpêtrière Hospital, from Friday, March 20, 2020', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years and older\n* Admitted in the Cardiac Intensive Care Unit from March 20th 2020\n* Patient informed and having expressed his non-opposition to participate in the research\n\nExclusion Criteria:\n\n* Minor patient\n* Patient who expressed opposition to participation in the study'}, 'identificationModule': {'nctId': 'NCT04344912', 'acronym': 'CCU-COVID19', 'briefTitle': 'Impact of COVID19 Outbreak in Cardiac Acute Care', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Impact of COVID19 Outbreak in Cardiac Patients Admitted in Intensive Care Unit : the CCU-COVID19 Study', 'orgStudyIdInfo': {'id': 'APHP200524'}, 'secondaryIdInfos': [{'id': '0522070420', 'type': 'OTHER', 'domain': 'INDS'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'COVID19- Population', 'description': 'Patients without diagnosis of COVID19, as assessed by RT-PCR and CT scan', 'interventionNames': ['Other: Data collection']}, {'label': 'COVID19+ Population', 'description': 'Patients with a diagnosis of COVID19, as assessed by RT-PCR and CT scan', 'interventionNames': ['Other: Data collection']}], 'interventions': [{'name': 'Data collection', 'type': 'OTHER', 'description': "Diagnostic and prognostic evaluation of cardiac patients hospitalized in CCU during the COVID-19 outbreak; patient's immune status regarding the presence of SARS-CoV-2 specific antibodies", 'armGroupLabels': ['COVID19+ Population', 'COVID19- Population']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75013', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Johanne SILVAIN, MD PhD', 'role': 'CONTACT', 'email': 'johanne.silvain@aphp.fr', 'phone': '+33142162961'}], 'facility': 'Unité de Soins Intensifs de Cardiologie, Pitié Salpêtrière Hospital, AP-HP', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Johanne SILVAIN, MD PhD', 'role': 'CONTACT', 'email': 'johanne.silvain@aphp.fr', 'phone': '+33142162961'}], 'overallOfficials': [{'name': 'Johanne SILVAIN, MD PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sorbonne University, ACTION Group, AP-HP Pitié-Salpêtrière Hospital Paris France'}, {'name': 'Gilles MONTALESCOT, MD PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Sorbonne University, ACTION Group, AP-HP Pitié-Salpêtrière Hospital Paris France'}]}, 'ipdSharingStatementModule': {'timeFrame': 'The data will be available 12 months after the beginning of the Registry', 'ipdSharing': 'YES', 'description': 'Open to collaboration', 'accessCriteria': 'to be determined'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'Action, France', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}