Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2026-01-01 @ 12:48 PM
Study NCT ID:
NCT05895669
Status:
UNKNOWN
Last Update Posted:
2023-06-08
First Post:
2023-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardiovascular Outcomes in Orthotopic Liver Transplanted Patients (COLT Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D003643', 'term': 'Death'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2024-05-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-06', 'studyFirstSubmitDate': '2023-05-26', 'studyFirstSubmitQcDate': '2023-06-06', 'lastUpdatePostDateStruct': {'date': '2023-06-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiovascular death', 'timeFrame': 'From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months', 'description': 'death due to cardiac causes (myocardial infraction and/or stroke)'}, {'measure': 'cardiovascular complication', 'timeFrame': 'From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months', 'description': 'fatal and non fatal myocardial infraction and/or stroke'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Liver Transplant; Complications', 'Cardiovascular Complication', 'Cardiovascular; Attack', 'Cardiovascular Stroke', 'Death']}, 'descriptionModule': {'briefSummary': 'All patients with orthotopic liver transplantation who are evaluated and followed at each participating centers will be recorded in this study. Within this register a characterization of patients and therapy will be done. Prognostic factors of defined clinical relevant endpoints will be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with ortothopic liver transplantation', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients with ortothopic liver transplantation and at least 2 year follow-up at the referral center\n\nExclusion Criteria:\n\n* Missing Informed Consent Form\n* Missing Contact Informations for Follow up'}, 'identificationModule': {'nctId': 'NCT05895669', 'acronym': 'COLT', 'briefTitle': 'Cardiovascular Outcomes in Orthotopic Liver Transplanted Patients (COLT Study)', 'organization': {'class': 'OTHER', 'fullName': 'University of Campania Luigi Vanvitelli'}, 'officialTitle': 'Evaluation of Cardiovascular Outcomes in Patients Undergoing Orthotopic Liver Transplantation: a Retrospective Cohort Study', 'orgStudyIdInfo': {'id': '0012771/i'}}, 'contactsLocationsModule': {'locations': [{'zip': '80054', 'city': 'Gragnano', 'state': 'SA', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Carmine Coppola, MD', 'role': 'CONTACT'}, {'name': 'Carmine Coppola, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Gragnano Hospital', 'geoPoint': {'lat': 40.68907, 'lon': 14.52036}}, {'zip': '80138', 'city': 'Napoli', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Alfredo Caturano, MD', 'role': 'CONTACT', 'email': 'alfredo.caturano@unicampania.it'}, {'name': 'Teresa Salvatore, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Campania Luigi Vanvitelli', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}], 'centralContacts': [{'name': 'Alfredo Caturano, MD', 'role': 'CONTACT', 'email': 'alfredo.caturano@unicampania.it', 'phone': '+393338616985'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Campania Luigi Vanvitelli', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Alfredo Caturano', 'investigatorAffiliation': 'University of Campania Luigi Vanvitelli'}}}}