Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2025-12-25 @ 8:48 PM
Study NCT ID:
NCT06094569
Status:
RECRUITING
Last Update Posted:
2023-10-23
First Post:
2023-10-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Medical Imaging Screening for Posterior-circulation Ischemic Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-16', 'studyFirstSubmitDate': '2023-10-16', 'studyFirstSubmitQcDate': '2023-10-16', 'lastUpdatePostDateStruct': {'date': '2023-10-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'National Institutes of Health Stroke Scale (NIHSS) scores at 90 days', 'timeFrame': '90 days', 'description': "The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0."}, {'measure': 'Occurrence of periprocedural complications', 'timeFrame': '90 days', 'description': 'Periprocedural complications include any intracranial hemorrhage, cerebral edema, brain herniation and pneumonia.'}, {'measure': 'pc-ASPECT (posterior circulation Alberta Stroke Program Early CT score)', 'timeFrame': '0 days', 'description': 'pc-ASPECTS is a 10-point quantitative topographic CT scan score used in patients with posterior circulation stroke.'}], 'primaryOutcomes': [{'measure': 'Modified ranking scale (mRS) at 90 days', 'timeFrame': '90 days', 'description': 'A 0-6 scale running from perfect health without symptoms to death.'}], 'secondaryOutcomes': [{'measure': 'Mortality within 90 days', 'timeFrame': '90 days', 'description': 'mortality of any causes.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['select patients', 'endovascular thrombectomy', 'magnetic resonance imaging', 'diffusion weighted imaging', 'Vertebrobasilar artery'], 'conditions': ['Endovascular Thrombectomy']}, 'descriptionModule': {'briefSummary': 'Patients with ischemic stroke in the posterior circulation continue to have high rates of mortality and disability, even with aggressive treatment. We wanted to evaluate preoperative imaging to screen patients with a good prognosis from mechanical embolization. We assess the degree of ischemia by defining the pons-midbrain-medulla index (PMMI) and correlate the preoperative PMMI with the clinical prognosis of postoperative patients to verify the validity of PMMI in predicting the clinical prognosis of patients with embolization.', 'detailedDescription': "* The ENDOSTROKE registry (Endovascular Stroke T reatment Registry), the use of MRI before EVT was associated with significantly better clinical outcomes as compared to CT.\n* The purpose of the study will sift patients with posterior circulation ischemia stroke who will get better outcome by Mechanical Thrombectomy by neuroimaging.Specifically, the following assumption will be evaluated: the modified pons-midbrain index in magnetic resonance imaging can predict the clinical outcome of patients with basilar artery thrombosis 90 days after surgery, and can guide whether patients will undergo mechanical thrombectomy later.\n* Pons-midbrain-medulla index (PMMI) : We divide pons-midbrain-medulla into the left and right sides by the median line of the brainstem,so we will evaluate ischemia of these six layers which are endowed different score according to the degree of ischemia. Instead of the previous pons-midbrain index (PMI), we select the image layer that shows the largest infarct size among the six parts.Then,we add up six scores that is patient's PMMI. Scoring criteria: At the layer of displaying the maximum infarct size, 2 points are scored if the infarct size exceeds 50% of the total area, 1 point is scored if the infarct size is less than 50% of the total area, and 0 points are scored if there is no infarct.Finally, PMMI values range from 0 to 12 points.\n* The investigators conduct a multicenter, prospective cohort study.Preoperative images of patients are evaluated by different groups of imaging physicians to describe the association between preoperative PMMI and clinical prognosis in patients with posterior circulation stroke and to verify its validity."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All acute ischemic strvoke patients with vertebrobasilar artery occlusion.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patient admitted from Jun. 1st 2019 to Jan. 1st 2029;\n2. Patients with acute ischemic stroke recently；\n3. Symptoms persisted at admission, and MRI (including DWI) confirmed acute ischemic vertebrobasilar artery occlusion in the posterior circulation:（single right or left intracranial branch of vertebral artery occlusion ; single basilar occlusion ; both two vertebral arterys and basilar artery）；\n\nExclusion Criteria:\n\n1.Patiens can not meet the MRI examination conditions(with absolute and relative contraindications).'}, 'identificationModule': {'nctId': 'NCT06094569', 'briefTitle': 'Medical Imaging Screening for Posterior-circulation Ischemic Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Tianjin Huanhu Hospital'}, 'officialTitle': 'Medical Imaging Screening for Posterior-circulation Ischemic Stroke：a Multicentre,Imaging-based,Prospective Cohort Study', 'orgStudyIdInfo': {'id': 'TJHH-2023-wm14'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Endovascular therapy', 'description': 'Timely thrombectomy for acute ischemic stroke patients with large vessel occlusion by either stent retriever, thrombus aspiration, others, or combination methods.', 'interventionNames': ['Procedure: Endovascular Therapy']}, {'label': 'Best medical management', 'description': 'Patients enrolled in this group received the best medical management.'}], 'interventions': [{'name': 'Endovascular Therapy', 'type': 'PROCEDURE', 'description': 'Endovascular therapy, as an adjunct to standard stroke therapy, may be beneficial for a very select population of patients who present with an acute ischemic stroke and have a proven large, proximal occlusion on imaging. Endovascular therapy includes any one or more of the following: Intra-arterial thrombolytic therapy, aspiration, stent retrieval, or a combination of multiple mechanical devices', 'armGroupLabels': ['Endovascular therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '300052', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xuanye Yue, MD', 'role': 'CONTACT', 'email': 'yuexy2002@aliyun.com', 'phone': '022-60814622'}, {'name': 'Xuanye Yue, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Tianjin Medical University General Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'zip': '300211', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhenjian Ma, MD', 'role': 'CONTACT', 'email': 'mazhenjian@126.com', 'phone': '18322412226'}, {'name': 'Zhenjian Ma, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Sencond Hospital of Tianjin Medical University', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'zip': '300222', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ming Wei, PhD', 'role': 'CONTACT', 'email': 'drweiming@163.com', 'phone': '13502182903'}, {'name': 'Ming Wei, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Tianjin Huanhu Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'zip': '300450', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wanchao Shi, MD', 'role': 'CONTACT', 'email': 'swc9801@sina.com', 'phone': '15620177339'}, {'role': 'CONTACT', 'phone': 'Wanchao'}, {'name': 'Wanchao Shi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Beijing University Binhai Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'centralContacts': [{'name': 'Ming Wei, PhD', 'role': 'CONTACT', 'email': 'drweiming@163.com', 'phone': '13502182903'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tianjin Huanhu Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief Physician', 'investigatorFullName': 'Ming Wei', 'investigatorAffiliation': 'Tianjin Huanhu Hospital'}}}}