Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2026-01-11 @ 1:46 PM
Study NCT ID:
NCT05920902
Status:
UNKNOWN
Last Update Posted:
2023-06-27
First Post:
2023-02-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Arterial Spin Label Depicted Ischemic Stroke Cohort (ASLIS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}], 'ancestors': [{'id': 'D020521', 'term': 'Stroke'}, {'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-24', 'studyFirstSubmitDate': '2023-02-09', 'studyFirstSubmitQcDate': '2023-06-24', 'lastUpdatePostDateStruct': {'date': '2023-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progressively deterioration in acute phase', 'timeFrame': '7 days after ischemia stroke onset', 'description': 'Number of participants whose SNOB (Standardised nursing observations for stroke) score at 7 days post ischemia stroke ≤ 2 points compared to baseline, and/or NIHSS score at 7 days post ischemia stroke ≥ 2 points compared to baseline are identified as progressively deterioration in acute phase.'}, {'measure': 'Bad prognosis of acute ischemia stroke', 'timeFrame': '90 days after ischemia stroke onset', 'description': 'Number of participants whose mRS (Modified rankin scale) score at 90 days after ischemia \\> 2 are identified as bad prognosis.'}], 'secondaryOutcomes': [{'measure': 'Recurrent vascular episode', 'timeFrame': '1 year', 'description': 'Including transient ischemia attack, intracranial hemorrhage, ischemia stroke'}, {'measure': 'Recurrent artery stenosis', 'timeFrame': 'one year after stenting', 'description': 'Degree of artery stenosis at one year after stenting \\> 50%'}, {'measure': 'Unhealthy status', 'timeFrame': '1 year', 'description': 'Any dimension in EQ-5D-3L (the generic three-level EuroQol five-dimensional questionnaire) score ≥ 2'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['acute ischemia stroke, arterial spin labeling, evaluation'], 'conditions': ['Acute Ischemic Stroke']}, 'descriptionModule': {'briefSummary': 'Establish a clinical cohort of acute ischemic stroke patients and find the determinant of the prognosis.', 'detailedDescription': '1. Enrollment: screening the candidates based on the inclusion and exclusion criteria, and sign the informed consent.\n2. Baseline evaluation: evaluate baseline situation of enrolled candidates.\n3. Inpatient view: view and evaluate enrolled candidates respectively at day 1, 3, 7 and 14 after stroke, and record the results.\n4. Follow-up: view the candidates at 90 days and one year after stroke onset, and record the results.\n5. Data analysis: analyze the results.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '30 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Who sufferred acute ischemia stroke and be admitted to the ward of Ruijin Hospital, and meets the inclusion criteria, and does not meet the exclusion criteria.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 30-90, no gender restrictions.\n2. Onset of disease ≤7 days.\n3. Meet either of the following two conditions:\n\n ① Transient ischemic attack (TIA)\n\n ② Ischemia stroke (IS) Note: Acute IS diagnosis criteria: sudden and persistent focal or widespread neurological dysfunction, excluding other non-vascular causes of brain dysfunction (such as brain infection, head injury, brain tumor, epilepsy, severe metabolic diseases, or degenerative neurological diseases), confirmed by image as new IS. TIA diagnosis criteria: sudden and reversible focal neurological or retinal ischemic deficit caused by a reversible ischemia, usually lasting less than 24 hours, with no evidence of new IS on imaging, and excluding other non-ischemic causes (such as brain infection, head injury, brain tumor, epilepsy, severe metabolic diseases, or degenerative neurological diseases).\n4. Signed informed consent\n\nExclusion Criteria:\n\n1. Clear cause of ischemic stroke other than atrial fibrillation.\n2. Other ischemic strokes with a clear cause.\n3. Presence of non-vascular intracranial disease.\n4. Presence of severe systemic diseases.\n5. Pregnancy or lactation.\n6. Unable to tolerate or cooperate with MRI examination.\n7. Unable to comply with follow-up due to geographical or other reasons.'}, 'identificationModule': {'nctId': 'NCT05920902', 'acronym': 'ASLIS', 'briefTitle': 'Arterial Spin Label Depicted Ischemic Stroke Cohort (ASLIS)', 'organization': {'class': 'OTHER', 'fullName': 'Ruijin Hospital'}, 'officialTitle': 'Arterial Spin Label Depicted Ischemic Stroke Cohort (ASLIS)', 'orgStudyIdInfo': {'id': 'RJ_ASLIS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Acute ischemia stroke', 'description': 'Best medcine treatment. It including antiplatelet drugs, statins, hypotensive drugs, antidiabetics, neurotrophic drugs, butylphthalide, edaravone.', 'interventionNames': ['Other: routine therapy of acute ischemia stroke']}], 'interventions': [{'name': 'routine therapy of acute ischemia stroke', 'type': 'OTHER', 'description': 'Routine therapy of acute ischemia stroke based on the guidelines, which generally includes two parts: evaluation and medicine treatment. Evaluation includes peripheral blood test, radiologic examination, electrophysiological examination, ultrasonic examination. Medicine treatment includes drug therapy and rehabilitation.', 'armGroupLabels': ['Acute ischemia stroke']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200000', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Ruijin hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Wei Jin, PhD. MD.', 'role': 'CONTACT', 'email': 'jw12170@rjh.com.cn', 'phone': '18916705082'}], 'overallOfficials': [{'name': 'Wei Jin, PhD. MD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ruijin Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Results of the research will be shared in the form of paper publishing. Other researchers who wants to know the details can contact with the PI.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ruijin Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}