Ignite Creation Date:
2025-12-24 @ 4:32 PM
Ignite Modification Date:
2025-12-30 @ 3:32 AM
Study NCT ID:
NCT06391866
Status:
RECRUITING
Last Update Posted:
2024-04-30
First Post:
2024-04-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neuroinflammation/Oxidative Stress/Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}], 'ancestors': [{'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005112', 'term': 'Extracorporeal Circulation'}], 'ancestors': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-25', 'studyFirstSubmitDate': '2024-04-17', 'studyFirstSubmitQcDate': '2024-04-25', 'lastUpdatePostDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number and type of early complications after surgery', 'timeFrame': '1 month', 'description': 'Estimating of postoperative complications'}, {'measure': 'Number and type of postoperative complications', 'timeFrame': '6 months', 'description': 'Estimating of postoperative complications'}], 'secondaryOutcomes': [{'measure': 'Estimating biochemical parameters', 'timeFrame': '1 hour', 'description': 'Pro-inflammatory interleukins parameters (e.g. IL-8, IL-6, MIP-1a, MMP-2, MMP-9, SIRT 1, SIRT 2)'}, {'measure': 'Estimating biochemical parameters', 'timeFrame': '6 hours', 'description': 'Pro-inflammatory interleukins'}, {'measure': 'Estimating biochemical parameters Third biochemical examination', 'timeFrame': '1 hour', 'description': 'Antioxidative enzymes'}, {'measure': 'Estimating biochemical parameters', 'timeFrame': '6 hours', 'description': 'Antioxidative enzymes'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neuroinflammation']}, 'referencesModule': {'references': [{'pmid': '41393743', 'type': 'DERIVED', 'citation': 'Kocan L, Sudzina R, Kocanova H, Zavacka M, Pobehova J, Rybar D, Dudova M, Ferencik M, Vaskova J. Early Cognitive Outcomes After Carotid Endarterectomy in Asymptomatic Stenosis: A Pilot Study. Cureus. 2025 Nov 11;17(11):e96559. doi: 10.7759/cureus.96559. eCollection 2025 Nov.'}]}, 'descriptionModule': {'briefSummary': 'The prospective observational study delves into the complex relationship between neuroinflammation and oxidative stress in post-cardiac surgery complications, focusing on postoperative cognitive dysfunction.', 'detailedDescription': 'The prospective observational study meticulously examines the interplay between neuroinflammation and oxidative stress in the realm of post-cardiac surgery complications, specifically targeting postoperative cognitive dysfunction. Its primary objective is to comprehensively assess the sustained influence of these intricate processes on cognitive function and overall well-being, extending beyond the immediate aftermath of surgery. The research endeavors to probe deeply into the molecular mechanisms and clinical ramifications associated with neuroinflammation and oxidative stress, centering on their pivotal role in shaping the onset and trajectory of postoperative cognitive dysfunction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient undergoing cardiac surgery', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Undergoing cardiosurgical operation\n* Absence of previous neurological disease\n* Signed informed consent document\n\nExclusion Criteria:\n\n* Presence of neoplasms\n* Neurological Disease\n* Refusal to participate in the clinical trial'}, 'identificationModule': {'nctId': 'NCT06391866', 'acronym': 'NEuOX-postSURg', 'briefTitle': 'Neuroinflammation/Oxidative Stress/Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Europainclinics z.ú.'}, 'officialTitle': 'Assessing Neuroinflammation and Oxidative Stress After Cardiac Surgery: Unveiling Molecular Dynamics and Clinical Outcomes', 'orgStudyIdInfo': {'id': 'NeuOX-postSurg Trial'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Experimental group 1', 'description': 'Patients scheduled for elective cardiac surgery, such as coronary artery bypass grafting (CABG) or valve replacement, involving extracorporeal circulation (ECC) with a duration less than 60 minutes.', 'interventionNames': ['Other: extracorporeal circulation']}, {'label': 'Experimental group 2', 'description': 'Patients undergoing scheduled cardiac procedures, including coronary artery bypass grafting (CABG) or valve replacement, requiring extracorporeal circulation (ECC) for more than 60 minutes.', 'interventionNames': ['Other: extracorporeal circulation']}, {'label': 'Control group:', 'description': 'Patients scheduled for cardiac surgical procedures such as coronary artery bypass grafting (CABG) without extracorporeal circulation, and for carotid endarterectomy in neurologically asymptomatic patients prior to the procedure.'}], 'interventions': [{'name': 'extracorporeal circulation', 'type': 'OTHER', 'description': 'extracorporeal circulation during cardiosurgical operation', 'armGroupLabels': ['Experimental group 1', 'Experimental group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04011', 'city': 'Košice', 'status': 'RECRUITING', 'country': 'Slovakia', 'contacts': [{'name': 'Ladislav Kočan, MD PhD', 'role': 'CONTACT'}], 'facility': 'Europainclinics', 'geoPoint': {'lat': 48.71441, 'lon': 21.25802}}], 'centralContacts': [{'name': 'Ladislav Kočan, MD, PhD, FIPP', 'role': 'CONTACT', 'email': 'europainclinicsstudy@gmail.com', 'phone': '+421557891110'}, {'name': 'Janka Vašková, prof. Dr. PhD.', 'role': 'CONTACT', 'email': 'janka.vaskova@upjs.sk'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'After completing data collection, the data will be made available to the ethical committees of interested institutions'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Europainclinics z.ú.', 'class': 'OTHER'}, 'collaborators': [{'name': 'East Slovak Institute for Cardiovascular Diseases', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}