Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2026-02-23 @ 11:35 AM
Study NCT ID:
NCT02540733
Status:
UNKNOWN
Last Update Posted:
2017-06-14
First Post:
2015-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MRI Study of the Structural and Functional Rehabilitation in the Cerebral Infarction Patients With Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D002544', 'term': 'Cerebral Infarction'}], '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'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D020520', 'term': 'Brain Infarction'}, {'id': 'D002545', 'term': 'Brain Ischemia'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-01-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-06-10', 'studyFirstSubmitDate': '2015-08-26', 'studyFirstSubmitQcDate': '2015-09-01', 'lastUpdatePostDateStruct': {'date': '2017-06-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'modified Rankin scale (mRS)', 'timeFrame': '6 months', 'description': 'scores range from 0 (no symptoms) to 6 (dead)'}, {'measure': 'National Institute of Health Stroke Score', 'timeFrame': '6 months', 'description': 'scores ranging from 0 to 42 (the higher the score, the greater the function deficits)'}, {'measure': 'Barthel index', 'timeFrame': '6 months', 'description': 'score ranging from 0 (totally dependent) to 100 (completely independent)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['cerebral infarction', 'diabetes', 'rehabilitation', 'MRI'], 'conditions': ['Cerebral Stroke', 'Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'Diabetes mellitus (DM) plays an important role in the occurrence of the cerebral infarction (CI). Clinical studies have demonstrated that the CI patients with DM had a poor prognosis compared with those without DM. Previous magnetic resonance imaging (MRI) studies have shown that patients with DM had abnormalities in cerebral vessels, nerves and functions, similar with the findings in mice models. In this study, with multi-modal MRI technologies, investigators tend to observe structural and functional changes of the brain in both DM and non-DM CI patients and assess their neural rehabilitation using clinical scales in the following 6 months. Investigators also expect to find out dynamic changes of brain structure and function, to reveal the weights of factors including brain blood vessels, nerves and function remodeling related with stroke recovery, as well as the potential mechanism in CI patients with DM.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'with a definition of stroke within 3 to 7 days after onset', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. first-ever ischemic stroke;\n2. single infarct in the distribution of the middle cerebral artery;\n3. no evidence of hemorrhagic infarction;\n4. age greater than 18 years;\n5. admission between 3 and 7 days after stroke onset;\n6. National Institute of Health Stroke Score (NIHSS) score of 4 to 21 on admission and\n7. no thrombolytic or recanalization therapies.\n\nExclusion Criteria:\n\n1. atrial fibrillation;\n2. history of neurological or psychiatric disorders;\n3. pre-stroke modified Rankin scale (mRS) \\> 1;\n4. life expectancy \\< 1 year.'}, 'identificationModule': {'nctId': 'NCT02540733', 'briefTitle': 'MRI Study of the Structural and Functional Rehabilitation in the Cerebral Infarction Patients With Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Zhejiang University'}, 'officialTitle': 'MRI Study of the Structural and Functional Rehabilitation in the Cerebral Infarction Patients With Diabetes', 'orgStudyIdInfo': {'id': '81271530'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Diabetic stroke'}, {'label': 'Non-diabetic storke'}]}, 'contactsLocationsModule': {'locations': [{'zip': '310009', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xinfeng Yu, PhD', 'role': 'CONTACT', 'email': 'angek-4125@163.com', 'phone': '86-18758187391'}, {'name': 'Minming Zhang, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The 2nd Affiliated Hospital of Zhejiang University, School of Medicine,', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Minming Zhang, PhD', 'role': 'CONTACT', 'email': 'zhangminming@zju.edu.cn', 'phone': '86-0571-87315255'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief,Department of Radiology,The 2nd Affiliated Hospital of Zhejiang University, School of Medicine', 'investigatorFullName': 'Minming Zhang', 'investigatorAffiliation': 'Zhejiang University'}}}}