Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-27 @ 1:35 AM
Study NCT ID:
NCT05140850
Status:
UNKNOWN
Last Update Posted:
2021-12-08
First Post:
2021-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-term Consequences of Neuroimaging and Perceived Cognitive Dysfunction in oPRES
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D054038', 'term': 'Posterior Leukoencephalopathy Syndrome'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D020343', 'term': 'Hypertensive Encephalopathy'}, {'id': 'D019586', 'term': 'Intracranial Hypertension'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D056784', 'term': 'Leukoencephalopathies'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2023-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-12-07', 'studyFirstSubmitDate': '2021-11-09', 'studyFirstSubmitQcDate': '2021-11-21', 'lastUpdatePostDateStruct': {'date': '2021-12-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'neuroimaging examination', 'timeFrame': 'within 10 years after deliver', 'description': 'the degree of white matter lesions(0,normal; 1, limited cortical or subcortical white matter oedema; 2, white matter oedema \\> cortical oedema, white matter oedema extending into deep white matter; 3, white matter oedema \\> cortex oedema, oedema extending to the ventricular surface; 4, the involved regions substantially extend to the ventricular surface and are almost completely confluent; 5, involved regions are fully confluent and continuous, ventricular deformity due to the oedema).The value of fractional anisotropy(FA) in PRES group may higher than non- PRES group, and mean diffusivity (MD) in PRES group may lower than non- PRES group.'}, {'measure': 'neuro-cognitive test of Mini-mental State Examination', 'timeFrame': 'within 10 years after deliver', 'description': 'the scores of Mini-mental State Examination,normal (27-30);mild (21-26); moderate (10-20); severe (0-9).'}, {'measure': 'neuro-cognitive test of Montreal Cognitive Assessment', 'timeFrame': 'within 10 years after deliver', 'description': 'the scores of Montreal Cognitive Assessment,normal (≥26); abnormal (\\<26).'}, {'measure': 'blood pressure and hypertension', 'timeFrame': 'within 10 years after deliver', 'description': 'Hypertension: blood pressure ≥140/90 mmHg'}, {'measure': 'level of lactate dehydrogenase(LDH)', 'timeFrame': 'within 10 years after deliver', 'description': 'inflammatory: LDH\\>380U/L'}, {'measure': 'level of LDL in blood', 'timeFrame': 'within 10 years after deliver', 'description': 'hyperlipidemia：LDL\\>3.12mmol/L'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neuroimaging', 'Cognitive Dysfunction', 'Posterior Reversible Encephalopathy Syndrome']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to explore the long-term consequences of neuroimaging and perceived cognitive dysfunction in obstetrics posterior reversible encephalopathy syndrome.', 'detailedDescription': 'This is a prospective study. The investigators divided the PE or E patients into two groups, namely PRES group and non-PRES group, according to diagnostic criteria . The general information（demographic data，blood pressure.etc.）and blood sample will be collected. Additionally,all patients receive neuroimaging examination（DTI,ASL,3D-TMI.etc.）and neuro-cognitive test（MMSE,MOCA,CFQ, etc.） to assess the cerebral white matter lesions and cognitive changes.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '15 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'We divided the PE or E patients into two groups, namely PRES group and non-PRES group, according to diagnostic criteria . the general information（demographic data，blood pressure.etc.）and blood sample will be collected.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. patients were diagnosed of PE or E\n2. patients received cranial image examination\n3. patients consent to participate\n\nExclusion Criteria:\n\n1. patients combined other neurological diseases\n2. patients combined mental illness'}, 'identificationModule': {'nctId': 'NCT05140850', 'briefTitle': 'Long-term Consequences of Neuroimaging and Perceived Cognitive Dysfunction in oPRES', 'organization': {'class': 'OTHER', 'fullName': 'Guangzhou Medical University'}, 'officialTitle': 'Long-term Consequences of Neuroimaging and Perceived Cognitive Dysfunction in Obstetrics Posterior Reversible Encephalopathy Syndrome', 'orgStudyIdInfo': {'id': '82001568'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'PRES group', 'description': 'PE or E with PRES', 'interventionNames': ['Biological: neuroimaging examination,neuro-cognitive test,blood pressure,blood sample']}, {'label': 'non-PRES group', 'description': 'PE or E without PRES', 'interventionNames': ['Biological: neuroimaging examination,neuro-cognitive test,blood pressure,blood sample']}], 'interventions': [{'name': 'neuroimaging examination,neuro-cognitive test,blood pressure,blood sample', 'type': 'BIOLOGICAL', 'description': 'neuroimaging will be perform,neuro-cognitive will be tested,blood pressure will be monitored,blood samples will be tested', 'armGroupLabels': ['PRES group', 'non-PRES group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510150', 'city': 'Guangzhou', 'country': 'China', 'facility': 'Department of Obstetrics and Gynecology, Key Laboratory for Major Obstetric Diseases of Guangdong Province, The Third Affiliated Hospital of Guangzhou Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Dunjin Chen', 'role': 'CONTACT', 'email': 'gzdrchen@gzhmu.edu.cn', 'phone': '18928916722'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dunjin Chen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director of obstetrics', 'investigatorFullName': 'Dunjin Chen', 'investigatorAffiliation': 'Guangzhou Medical University'}}}}