Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2026-02-17 @ 5:48 PM
Study NCT ID:
NCT05208203
Status:
RECRUITING
Last Update Posted:
2022-01-26
First Post:
2022-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
XuanwuH Acute Ischemic Stroke Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}], 'ancestors': [{'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-12', 'studyFirstSubmitDate': '2022-01-12', 'studyFirstSubmitQcDate': '2022-01-12', 'lastUpdatePostDateStruct': {'date': '2022-01-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'modified ranking scale on day (mRs) day 90', 'timeFrame': '90 days', 'description': 'mRs: modified ranking scale; the scale is a commonly used measurement for the degree of disability or dependence in the daily activities of people who have suffered a stroke; scale range 0-6, with 0 - No symptoms. 1 - No significant disability. Able to carry out all usual activities, despite some symptoms. 2 - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3 - Moderate disability. Requires some help, but able to walk unassisted. 4 - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6 - Dead.'}], 'secondaryOutcomes': [{'measure': 'Stroke Event', 'timeFrame': '1year', 'description': 'The patients were monitored whether they recured ischemic stroke event including transient ischemic attack (TIA) or stroke confirmed by neurologist and diffusion-weighted image MRI.'}, {'measure': 'adverse event', 'timeFrame': '1year', 'description': 'The patients were monitored whether they appeared symptomatic intracranial hemorrhage,cerebral hernia or other life-threatening events.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Stroke', 'Cerebrovascular disease'], 'conditions': ['Acute Ischemic Stroke']}, 'referencesModule': {'references': [{'pmid': '30879893', 'type': 'BACKGROUND', 'citation': 'GBD 2016 Neurology Collaborators. Global, regional, and national burden of neurological disorders, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2019 May;18(5):459-480. doi: 10.1016/S1474-4422(18)30499-X. Epub 2019 Mar 14.'}, {'pmid': '26120643', 'type': 'BACKGROUND', 'citation': 'Harris D, Hall C, Lobay K, McRae A, Monroe T, Perry JJ, Shearing A, Wollam G, Goddard T, Lang E. Canadian Association of Emergency Physicians position statement on acute ischemic stroke. CJEM. 2015 Mar;17(2):217-26. doi: 10.1017/cem.2015.26.'}, {'pmid': '3363593', 'type': 'RESULT', 'citation': 'van Swieten JC, Koudstaal PJ, Visser MC, Schouten HJ, van Gijn J. Interobserver agreement for the assessment of handicap in stroke patients. Stroke. 1988 May;19(5):604-7. doi: 10.1161/01.str.19.5.604.'}]}, 'descriptionModule': {'briefSummary': 'Acute ischemic stroke registry--Xuanwu Hospital(XSR) is an academic, independent, prospective, single center, observational registry study. Consecutive acute ischemic stroke patients assessed in stroke "green channel" of Xuanwu Hospital(China) will be enrolled in our study. Patients receive regular treatment and data will be collected as part of clinical routine. Baseline clinical and procedural information as well clinical follow-up information during in-hospital stay, and up to 90 days of stroke onset are collected. Data collected include demographics, National Institute of Health Stroke Scale (NIHSS) on admission, pre-treatment ASPECTS, information on timing and success of thrombolysis or thrombectomy, procedural complications, intracranial hemorrhage, and functional outcome.The study aim to investigate the real situation of assessment, diagnosis and treatment of acute ischemic stroke patients in "green channel",and verify the effect of the improvement of "green channel" process in the diagnosis and treatment of patients with acute ischemic stroke.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'all acute stroke patients with the clinical diagnosis of acute ischemic stroke, Age \\>18 years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of acute ischemic stroke or transient ischemic attack(TIA)\n* Age \\>18 years\n* Ethic approval in process\n* Receiving assessment in stroke "green channel" of Xuanwu Hospital\n\nExclusion Criteria:\n\n* Non-acute ischemic stroke'}, 'identificationModule': {'nctId': 'NCT05208203', 'briefTitle': 'XuanwuH Acute Ischemic Stroke Registry', 'organization': {'class': 'OTHER', 'fullName': 'Xuanwu Hospital, Beijing'}, 'officialTitle': 'Acute Ischemic Stroke "Green Channel" Registry--Xuanwu Hospital', 'orgStudyIdInfo': {'id': 'qingfeng ma stroke xuanwuH'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'stroke patients', 'description': 'acute ischemic stroke patients including all treatments.', 'interventionNames': ['Other: telephone call d90']}], 'interventions': [{'name': 'telephone call d90', 'type': 'OTHER', 'description': 'telephone call on day 90 to assess the primary outcome (mRs d90)', 'armGroupLabels': ['stroke patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100053', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'qingfeng Ma, MD', 'role': 'CONTACT', 'email': 'm.qingfeng@163.com', 'phone': '+8613601069493'}], 'facility': 'Xuanwu Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'qingfeng Ma, MD', 'role': 'CONTACT', 'email': 'm.qingfeng@163.com', 'phone': '+8613601069493'}, {'name': 'chuming Yan, MBBS', 'role': 'CONTACT', 'email': 'ycm19960214@163.com', 'phone': '+8618810673782'}], 'overallOfficials': [{'name': 'qingfeng Ma, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Xuanwu Hospital, Beijing'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xuanwu Hospital, Beijing', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'qingfengma', 'investigatorAffiliation': 'Xuanwu Hospital, Beijing'}}}}