Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2026-02-06 @ 9:58 AM
Study NCT ID:
NCT02394405
Status:
TERMINATED
Last Update Posted:
2019-08-15
First Post:
2015-02-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Myocardial and Renal Dysfunction by Oxidative Stress Caused by Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015427', 'term': 'Reperfusion Injury'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-13', 'studyFirstSubmitDate': '2015-02-12', 'studyFirstSubmitQcDate': '2015-03-16', 'lastUpdatePostDateStruct': {'date': '2019-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-03-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assay of mtDNA', 'timeFrame': 'from baseline whithin 72 hours'}], 'secondaryOutcomes': [{'measure': 'Assay of nDNA', 'timeFrame': 'from baseline whithin 72 hours'}, {'measure': 'Assay of carbonilated proteins', 'timeFrame': 'from baseline whithin 72 hours'}, {'measure': 'Assay of nitrotyrosine', 'timeFrame': 'from baseline whithin 72 hours'}, {'measure': 'Assay of oxy-LDL', 'timeFrame': 'from baseline whithin 72 hours'}, {'measure': 'Assay of S100b-protein', 'timeFrame': 'from baseline whithin 72 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Reperfusion Injury']}, 'descriptionModule': {'briefSummary': 'Assessment of the severity of oxidative stress caused by the on-pump and off-pump cardiac surgery using mtDNA, nDNA, carbonilated proteins, nitrotyrosine, oxy-LDL, S100b-protein.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'primary care clinic', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* shedduled CABG\n\nExclusion Criteria:\n\n* stroke befor surgery\n* miocardial infarction 6 monthes befor surgery\n* dementia\n* liver cirrhosis'}, 'identificationModule': {'nctId': 'NCT02394405', 'briefTitle': 'Myocardial and Renal Dysfunction by Oxidative Stress Caused by Cardiac Surgery', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Moscow Regional Research and Clinical Institute (MONIKI)'}, 'officialTitle': 'Myocardial and Renal Dysfunction by Oxidative Stress Caused by Cardiac Surgery', 'orgStudyIdInfo': {'id': 'OD-CABG-2015'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'valve surgery', 'description': 'valve plasty/replacement surgery'}, {'label': 'off-pump CABG', 'description': 'off-pump CABG'}, {'label': 'CPB-CABG', 'description': 'CABG with CardioPulmonal Bypass'}]}, 'contactsLocationsModule': {'locations': [{'zip': '129110', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Moscow Regional Research and Clinical Institute Moniki n.a. M.F. Vladimirskiy', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Moscow Regional Research and Clinical Institute (MONIKI)', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'senior researcher', 'investigatorFullName': 'Valery V. Likhvantsev, Professor', 'investigatorAffiliation': 'Moscow Regional Research and Clinical Institute (MONIKI)'}}}}