Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2025-12-25 @ 9:18 PM
Study NCT ID:
NCT03493256
Status:
COMPLETED
Last Update Posted:
2020-02-05
First Post:
2018-03-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Novel BIochemical Markers for Predicting Type 2 NEurological Complications of Surgical Coronary Revascularization (BINER)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-03', 'studyFirstSubmitDate': '2018-03-26', 'studyFirstSubmitQcDate': '2018-04-03', 'lastUpdatePostDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of serum GFAP concentration (ng/ml) changes.', 'timeFrame': 'GFAP concentrations will be measured preoperatively (at the time of initial skin incision), at the completion of surgery (at the time of skin closure) as well as 24 hours and 7 days following off-pump Coronary Artery Bypass Grafting (CABG).', 'description': 'Comparison of patients with and without type 2 neurological complications in respect to changes from baseline concentration of glial fibrillary acidic protein (GFAP).'}, {'measure': 'Assessment of serum NSP concentration (ng/ml) changes.', 'timeFrame': 'NSP concentrations will be measured preoperatively (at the time of initial skin incision), at the completion of surgery (at the time of skin closure) as well as 24 hours and 7 days following off-pump Coronary Artery Bypass Grafting (CABG).', 'description': 'Comparison of patients with and without type 2 neurological complications in respect to changes from baseline concentration of neuroserpin (NSP).'}, {'measure': 'Assessment of serum pNfH concentration (ng/ml) changes.', 'timeFrame': 'pNfH concentrations will be measured preoperatively (at the time of initial skin incision), at the completion of surgery (at the time of skin closure) as well as 24 hours and 7 days following off-pump Coronary Artery Bypass Grafting (CABG).', 'description': 'Comparison of patients with and without type 2 neurological complications in respect to changes from baseline concentration of neuroserpin phosphorylated axonal neurofilament subunit H (pNfH).'}, {'measure': 'Assessment of serum VILIP-1 concentration (ng/ml) changes.', 'timeFrame': 'VILIP-1 concentrations will be measured preoperatively (at the time of initial skin incision), at the completion of surgery (at the time of skin closure) as well as 24 hours and 7 days following off-pump Coronary Artery Bypass Grafting (CABG).', 'description': 'Comparison of patients with and without type 2 neurological complications in respect to changes from baseline concentration of visinin-like protein 1 (VILIP-1).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neurological Complication of Procedure (Disorder)']}, 'descriptionModule': {'briefSummary': 'In this single center prospective cohort study a total of 100 patients scheduled for elective off-pump CABG will be recruited. They will be allocated to one study and one control group according to the presence or absence of postoperative type 2 neurological complications. The two groups will be compared in terms of serum concentrations of glial fibrillary acidic protein (GFAP), neuroserpin (NSP), phosphorylated axonal neurofilament subunit H (pNfH) and visinin-like protein 1 (VILIP-1) at the time of skin incision and closure as well as 24 hours and 7 days following surgery. Diagnostic performance of these markers for predicting type 2 neurological complications of off-pump CABG will be assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All participants will be recruited from patients scheduled for elective off-pump CABG at the Department of Cardiac Surgery, Dr Antoni Jurasz Memorial University Hospital, Bydgoszcz, Poland.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients scheduled for elective off-pump Coronary Artery Bypass Grafting (CABG)\n\nExclusion Criteria:\n\n* neurological or psychiatric disorders\n* alcohol or drug abuse\n* preoperative left ventricular ejection fraction of less than 30%\n* extracranial carotid artery stenosis of more than 70%\n* scoring below age- and education-adjusted cut-off values in Mini-Mental State Examination (MMSE)\n* scoring over seven points on the subscales of the Hospital Anxiety and Depression Scale (HADS)'}, 'identificationModule': {'nctId': 'NCT03493256', 'acronym': 'BINER', 'briefTitle': 'Novel BIochemical Markers for Predicting Type 2 NEurological Complications of Surgical Coronary Revascularization (BINER)', 'organization': {'class': 'OTHER', 'fullName': 'Collegium Medicum w Bydgoszczy'}, 'officialTitle': 'Novel BIochemical Markers for Predicting Type 2 NEurological Complications of Surgical Coronary Revascularization (BINER): a Prospective Cohort Study.', 'orgStudyIdInfo': {'id': 'KB 776/2017'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'type 2 neurological complications present', 'description': 'The group of patients diagnosed with postoperative cognitive dysfunction (POCD) or postoperative delirium (POD), or both concurrently.', 'interventionNames': ['Other: exposure to type 2 neurological complications']}, {'label': 'type 2 neurological complications absent', 'description': 'The group of patients without neurological complications.'}], 'interventions': [{'name': 'exposure to type 2 neurological complications', 'type': 'OTHER', 'description': 'exposure to postoperative cognitive dysfunction (POCD) or postoperative delirium (POD), or both concurrently.', 'armGroupLabels': ['type 2 neurological complications present']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85-094', 'city': 'Bydgoszcz', 'state': 'Kuyavian-Pomeranian Voivodeship', 'country': 'Poland', 'facility': 'Department of Cardiac Surgery, Dr Antoni Jurasz Memorial University Hospital', 'geoPoint': {'lat': 53.1235, 'lon': 18.00762}}], 'overallOfficials': [{'name': 'Krzysztof Szwed, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Clinical Neuropsychology, Nicolaus Copernicus University, Collegium Medicum.'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'CSR'], 'timeFrame': 'Available without time limits.', 'ipdSharing': 'YES', 'description': 'The data that support the findings of this study are available from the corresponding author upon reasonable request.', 'accessCriteria': 'The data that support the findings of this study are available from the corresponding author upon reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Collegium Medicum w Bydgoszczy', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Krzysztof Szwed', 'investigatorAffiliation': 'Collegium Medicum w Bydgoszczy'}}}}