Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2025-12-26 @ 2:13 AM
Study NCT ID:
NCT06081205
Status:
RECRUITING
Last Update Posted:
2023-10-13
First Post:
2023-07-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Patients Admitted to a Cardiac Intensive Care Unit With Acute CardioVascular Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012770', 'term': 'Shock, Cardiogenic'}], 'ancestors': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular 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'}, {'id': 'D012769', 'term': 'Shock'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-04-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2027-04-26', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-06', 'studyFirstSubmitDate': '2023-07-10', 'studyFirstSubmitQcDate': '2023-10-06', 'lastUpdatePostDateStruct': {'date': '2023-10-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-26', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'In-hospital mortality', 'timeFrame': 'During the index admission (up to 8 weeks)', 'description': 'In-hospital all-cause mortality of patients with acute cardiovascular disease that require treatment in a CICU'}, {'measure': '30-day mortality', 'timeFrame': '30 days after discharge from hospital', 'description': '30-day all-cause mortality of patients with acute cardiovascular disease that require treatment in a CICU'}, {'measure': '1-year mortality', 'timeFrame': '1-year after discharge from hospital', 'description': '1-year all-cause mortality of patients with acute cardiovascular disease that require treatment in a CICU'}], 'secondaryOutcomes': [{'measure': 'In-hospital major adverse cardiac events (MACE)', 'timeFrame': 'During the index admission (up to 8 weeks)', 'description': 'In-hospital MACE of patients with acute cardiovascular disease that require treatment in a CICU'}, {'measure': '30-day major adverse cardiac events (MACE)', 'timeFrame': '30 days after discharge from hospital', 'description': '30-day MACE of patients with acute cardiovascular disease that require treatment in a CICU'}, {'measure': '1-year major adverse cardiac events (MACE)', 'timeFrame': '1-year after discharge from hospital', 'description': '1-year MACE of patients with acute cardiovascular disease that require treatment in a CICU'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiogenic Shock', 'Acute Decompensated Heart Failure', 'Acute Pulmonary Embolism', 'Acute Myocardial Infarction']}, 'descriptionModule': {'briefSummary': 'This is a registry of the patients that are admitted to CICU and treated by the Scientific Staff of the 2nd Department of Cardiology, due to an acute cardiovascular disease (acute coronary syndrome, acute heart failure, arrhythmia, pulmonary embolism, cardiac tamponade etc) in order to investigate the clinical characteristics of the patients, their outcome, identify the factors that could predict the in-hospital mortality and compare the results with the predicted by established risk scores. Furthermore, the study will investigate the one-year mortality and also the major adverse cardiac events (MACE - acute myocardial infarction, stroke, or cardiovascular death) will be measured.', 'detailedDescription': "For every patient that will be enrolled to the study, information from the medical record will be collected, as long as he/she has provided a signed consent form after being fully informed of the study and its objectives. In case the patient cannot decide on his/her own, e.g. intubated patients, an informed consent form must be acquired by a relative or legal representative. Only the data that will be considered necessary for scientific reasons will be acquired: general and demographic information, medical information like the personal and family history, the diagnostic tests performed and the treatments or interventions that took place. The patients will not have to do anything further or undergo any additional visits or medical exams apart from those indicated; they will not receive any extra treatment (because of their participation to the study) beyond what they would receive for their condition according to the established practice so far. Furthermore, the doctor will not change or withdraw any treatment that the patients would normally receive. The patients' medical care will continue normally under the CICU doctors' supervision.\n\nThe participants will be monitored during their hospitalization in the CICU, during their hospitalization in the 2nd Department of Cardiology of the UHI after their discharge from CICU, as well as for the next 1-year in the Outpatients Clinic; if the latter is not feasible (in case of disability or distance) they will be contacted through telephone interviews."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients that are admitted through the Emergency Department of the UHI, transferred by other hospital clinics or by other regional secondary hospitals, with an acute cardiovascular disease that requires treatment in a CICU and are under scientific supervision of the 2nd Department of Cardiology, irrespectively of gender and age. In order to be enrolled, patients or their relative/legal representative (in cases stated above) must have signed an informed consent form', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients admitted to the Cardiac Intensive Care Unit (CICU) through the Emergency Department of the UHI\n* All patients transferred to the CICU from other hospital departments or other regional secondary hospitals\n* Patients with an acute cardiovascular disease that requires treatment in a CICU\n* Patients who are under scientific supervision of the 2nd Department of Cardiology\n* Patients (or their relative/legal representatives) that have signed the informed consent form\n\nExclusion Criteria: None'}, 'identificationModule': {'nctId': 'NCT06081205', 'briefTitle': 'Study of Patients Admitted to a Cardiac Intensive Care Unit With Acute CardioVascular Disease', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Ioannina'}, 'officialTitle': 'A Prospective Observational Study of Patients Admitted to a Cardiac Intensive Care Unit Due to Acute CardioVascular Disease.', 'orgStudyIdInfo': {'id': '10/270423'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Admission in the Cardiac Intensive Care Unit (CICU)', 'type': 'OTHER', 'otherNames': ['no further interventions'], 'description': 'all patients admitted in the CICU will be enrolled in the study provided they give their informed consent.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '45500', 'city': 'Ioannina', 'state': 'Epirus', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Aidonis Rammos, MD', 'role': 'CONTACT', 'email': 'aidrammos@yahoo.gr', 'phone': '+3026510 99111', 'phoneExt': '347'}, {'name': 'Konstantinos Siaravas, MD', 'role': 'CONTACT', 'email': 'siaravaskon@gmail.com', 'phone': '+3026510 99111', 'phoneExt': '863'}], 'facility': 'University Hospital of Ioannina', 'geoPoint': {'lat': 39.66341, 'lon': 20.85187}}], 'centralContacts': [{'name': 'Katerina K Naka, MD, PhD', 'role': 'CONTACT', 'email': 'anaka@uoi.gr', 'phone': '+30 26510 99111', 'phoneExt': '039'}, {'name': 'Aidonis Rammos, MD', 'role': 'CONTACT', 'email': 'aidrammos@yahoo.gr', 'phone': '+30 26510 99111', 'phoneExt': '347'}], 'overallOfficials': [{'name': 'Lampros K Michalis, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Professor of Cardiology, Director of the 2nd Cardiology Department, University Hospital of Ioannina'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Ioannina', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Cardiology', 'investigatorFullName': 'Katerina Naka', 'investigatorAffiliation': 'University Hospital, Ioannina'}}}}