Ignite Creation Date:
2025-12-24 @ 3:00 PM
Ignite Modification Date:
2026-02-25 @ 4:15 AM
Study NCT ID:
NCT03125759
Status:
RECRUITING
Last Update Posted:
2017-04-24
First Post:
2017-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Association of Omentin and Ischemic Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D002545', 'term': 'Brain Ischemia'}, {'id': 'D000083242', 'term': 'Ischemic Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Whole Blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-04-21', 'studyFirstSubmitDate': '2017-04-01', 'studyFirstSubmitQcDate': '2017-04-21', 'lastUpdatePostDateStruct': {'date': '2017-04-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the odds ratio of omentin plasma concentration between cases and controls', 'timeFrame': 'up to 3 years', 'description': 'The circulation level of omentin will be assessed in cases and controls. Then the odds ratio will be statically analysed to detect whether omentin is asociated with ischemic stroke on protein level.'}, {'measure': 'the frequency difference of single nucleotide polymorphism(SNP) of omentin in the enrolled subjects', 'timeFrame': 'up to 3 years', 'description': 'The SNP will be analysed in the recruited subjects. And the the frequency difference will be calculated to explore if any SNP is related to ischemic stroke.'}], 'secondaryOutcomes': [{'measure': 'the NIHSS assessed for functional outcome of stroke', 'timeFrame': 'up to 3 years', 'description': 'NIHSS wil be used to assess neurological status at baseline or the point of stroke, the point of out-patient, 3 month, 6 month, 1 year, 2 year and the 3 year.'}, {'measure': 'the modified Rankin Scale assessed for functional disability', 'timeFrame': 'up to 3 years', 'description': 'Th functional disability will be assessed using the modified Rankin Scale at the time of baseline, out-patient, 3rd month, 6th month, 1st year, 2nd year and the 3rd year after enrollment.'}, {'measure': 'the Barthel index assessed for functional independence in activities', 'timeFrame': 'up to 3 years', 'description': 'The Barthel index at the point of baseline, out-patient, 3rd month, 6th month, 1st year, 2nd year and the 3rd year after enrollment will be assessed for the functional independence in activities.'}, {'measure': 'the number of all cause death', 'timeFrame': 'up to 3 years', 'description': 'The number of all cause of death will be recorded in both groups.'}, {'measure': 'the number of re-stroke in case group', 'timeFrame': 'up to 3 years', 'description': 'Recurrent of stroke will be monitored through out in case group.'}]}, 'conditionsModule': {'keywords': ['Ischemic Stroke', 'Omentin'], 'conditions': ['Stroke', 'Brain Ischemia', 'Adipokines', 'Mutation']}, 'descriptionModule': {'briefSummary': 'This observational study aims to research whether there is a relationship between omentin and ischemic stroke on the aspects of incidence, severity, and recovery etc.', 'detailedDescription': 'To study the possible relationship between omentin and ischemic stroke, we intend to recruit the newly found acute ischemic stroke patients and patients without any stroke history and analysis the difference of plasma omentin level and the ITLN, which is the gene symbol of omentin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'the study population is from primary care clinic, physical examination center, and social volunteers.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* For ischemic stroke group,acute clinically defined ischemic stroke\n* For control group, without any history of stroke\n\nExclusion Criteria:\n\nFor ischemic stroke group\n\n* Hemorrhagic Stroke\n* Previous Ischemic Stroke For control group\n* The expected life expense less than 3 years'}, 'identificationModule': {'nctId': 'NCT03125759', 'briefTitle': 'The Association of Omentin and Ischemic Stroke', 'organization': {'class': 'OTHER_GOV', 'fullName': "Xi'an No.3 Hospital"}, 'officialTitle': 'The Association of Omentin and Ischemic Stroke', 'orgStudyIdInfo': {'id': 'NDIS001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control', 'description': 'patients without any history of stroke'}, {'label': 'Ischemic Stroke', 'description': 'patients with an episode of neurological dysfunction caused by focal cerebral, spinal, or retinal infarction within 72 hours.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '710018', 'city': 'Xi’an', 'state': 'Shanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Tian Ye, doctor', 'role': 'CONTACT'}], 'facility': "Xi'an No.3 Hospital", 'geoPoint': {'lat': 35.99785, 'lon': 113.52486}}], 'centralContacts': [{'name': 'Tian Ye, PhD', 'role': 'CONTACT', 'email': 'chhty@sina.com', 'phone': '+86 13519131549'}], 'overallOfficials': [{'name': 'Tian Ye, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Xi'an No.3 Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Xi'an No.3 Hospital", 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}