Ignite Creation Date:
2025-12-24 @ 10:53 PM
Ignite Modification Date:
2025-12-31 @ 9:35 PM
Study NCT ID:
NCT02164669
Status:
UNKNOWN
Last Update Posted:
2014-06-16
First Post:
2014-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exploration of Neuroimaging and Biochemical Prognostic Indicators for POCD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000079690', 'term': 'Postoperative Cognitive Complications'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': '4ml venous blood will be collected, and serum IL-6， IL-8，TNF-α，NSE，S100β will be detected.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'targetDuration': '7 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2014-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-06-13', 'studyFirstSubmitDate': '2014-06-12', 'studyFirstSubmitQcDate': '2014-06-13', 'lastUpdatePostDateStruct': {'date': '2014-06-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The brain structure changes', 'timeFrame': '7 days postoperatively', 'description': 'Using BOLD fMRI to investigate the variance of mean diffusivity and FA in nerve conduction bundle'}], 'secondaryOutcomes': [{'measure': 'Mini-Mental State Examination', 'timeFrame': 'preoperative and 7 days, 3 months and 1 years postoperative', 'description': 'Application of digital depth and breadth to test digital sign test Tracking the attachment test and assess depression self rating scale'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Inflammation', 'Coronary artery bypass graft', 'Magnetic Resonance Imaging'], 'conditions': ['Postoperative Cognitive Dysfunction', 'Cognitive Impairment']}, 'descriptionModule': {'briefSummary': 'Postoperative cognitive dysfunction (POCD) may lead to serious consequences. But the underlying mechanisms are still unclear. Blood Oxygen Level Dependent (BOLD) fMRI and biochemical indicators will be used to explore the underlying mechanisms and represent a promising precursory target for diagnosis and treatment of POCD.', 'detailedDescription': 'Postoperative cognitive dysfunction (POCD) is one of the most common complications in patients undergoing cardiac surgery. POCD will not only increase the incidence of complications and mortality, but also influence the quality of life after discharging from the hospital. Many factors are associated with POCD, such as neuroinflammation, age, anesthetics, surgery stress response and genetic factors. But the underlying mechanisms are still unclear. Blood Oxygen Level Dependent (BOLD) fMRI, which could monitor the peripheral neuron spontaneous activity according to the ratio of oxyhemoglobin and deaeration hemoglobin in blood, will be used to investigate whether POCD is induced by the variance in neurons metabolism and spontaneous activity in brain regions. Meanwhile, biochemical indicators will be detected to explore the prompting indicators of POCD. The present study is aimed to represent a promising precursory target for diagnosis and treatment of POCD, and provide novel evidence and insights on the brain changes induced by POCD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients will selective undergo Coronary Artery Bypass Grafting (CABG) surgery. Health adult', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18-80 years old\n* Underwent selective CABG surgery\n\nExclusion Criteria:\n\n* History of central nervous system or psychiatric disorders\n* History of taking sedative, antidepressants, or alcoholism\n* MMSE score less than 23\n* Visual or auditory disorders\n* Educated less than 7 years\n* Claustrophobia\n* Can not be supine\n* Can not tolerate iodinated contrast agents'}, 'identificationModule': {'nctId': 'NCT02164669', 'briefTitle': 'Exploration of Neuroimaging and Biochemical Prognostic Indicators for POCD', 'organization': {'class': 'OTHER', 'fullName': 'Xijing Hospital'}, 'officialTitle': 'Exploration of Neuroimaging and Biochemical Prognostic Indicators for Post-operative Cognitive Dysfunction After Coronary Artery Bypass Graft', 'orgStudyIdInfo': {'id': '20130225-8'}}, 'contactsLocationsModule': {'locations': [{'zip': '710032', 'city': "Xi'an", 'state': 'Shaanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qiang Wang, MD,PhD', 'role': 'CONTACT', 'email': 'wangqiang@fmmu.edu.cn', 'phone': '+86-29-84775343'}], 'facility': 'Xijign Hospital', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'centralContacts': [{'name': 'Qiang Wang, MD,PhD', 'role': 'CONTACT', 'email': 'Wangqiang@fmmu.edu.cn', 'phone': '+86-29-84775343'}], 'overallOfficials': [{'name': 'Qiang Wang, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Xijing Hospital'}, {'name': 'Zijun Gao, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Xijing Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'wangqiang', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'wangqiang', 'investigatorAffiliation': 'Xijing Hospital'}}}}