Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2026-01-01 @ 2:31 AM
Study NCT ID:
NCT01665235
Status:
UNKNOWN
Last Update Posted:
2012-08-15
First Post:
2012-08-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Blood Pressure Variability and the Prognosis of Ischemic Stroke With Intracranial Artery Stenosis
Sponsor:
Organization:
Raw JSON
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{'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013988', 'term': 'Ticlopidine'}, {'id': 'D058924', 'term': 'Thienopyridines'}, {'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006538', 'term': 'Heptanoic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2014-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-08-14', 'studyFirstSubmitDate': '2012-08-13', 'studyFirstSubmitQcDate': '2012-08-14', 'lastUpdatePostDateStruct': {'date': '2012-08-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the incidence of stroke in a follow-up period', 'timeFrame': 'one year'}], 'secondaryOutcomes': [{'measure': 'blood pressure during the compliance status in a follow-up', 'timeFrame': 'one year'}, {'measure': 'patients with blood pressure variability in a follow-up', 'timeFrame': 'one year'}, {'measure': 'Changes in intracranial arterial stenosis and stiffness before and after the follow-up', 'timeFrame': 'one year'}, {'measure': 'Other vascular events ( acute ischemic heart disease or vascular death )', 'timeFrame': 'one year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Blood Pressure Variability', 'Intracranial Artery Stenosis']}, 'descriptionModule': {'briefSummary': 'Correlation study about Blood Pressure Variability and the prognosis of ischemic stroke with intracranial artery stenosis', 'detailedDescription': 'Extracranial atherosclerotic stenosis is the main reason for the European and American white ischemic stroke and transient ischemic attack,while Atherosclerotic intracranial arterial stenosis is an important reason for Asian patients with stroke ,accounting for the 33% to 51% of a etiology ratio.The latest research suggests that varying degrees of blood pressure variability can affect the risk of stroke.This study observe the relationship between blood pressure variability and prognosis of ischemic stroke patients with intracranial arterial stenosis,with cranial magnetic resonance imaging (MRI + DWI),magnetic resonance angiography and Trans-cranial Doppler(TCD) .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age : ≥ 18 years of age , ≤ 75 years old\n* with intracranial artery stenosis in ischemic stroke\n* the diagnosis of ischemic cerebrovascular disease are in line with the diagnostic criteria developed by the Chinese Medical Association Fourth National Cerebrovascular Disease Conference\n* the patient admitted to hospital receive at least one examination like cranial MRI + DWI, MRA and TCD examination, clearly associated with intracranial arterial stenosis\n* MRS score ≤ 3 points\n\nExclusion Criteria:\n\n* vascular , cardiac , and unknown causes or other reasons lead to ischemic stroke\n* associated with significant emotional disorders, cognitive impairment or other mental disorders can not be partners\n* severe occlusion of Unilateral intracranial arteries ( over 90 % ) or bilateral stenosis more than 70%\n* With extracranial artery stenosis, especially carotid and vertebral artery stenosis .\n* patients with extracranial artery stenosis or patients previously done neck or intracranial artery balloon dilation , stent forming surgery or carotid endarterectomy\n* Incomplete clinical data collection in patients'}, 'identificationModule': {'nctId': 'NCT01665235', 'briefTitle': 'Blood Pressure Variability and the Prognosis of Ischemic Stroke With Intracranial Artery Stenosis', 'organization': {'class': 'OTHER', 'fullName': 'RenJi Hospital'}, 'officialTitle': 'The Correlation Study Between Blood Pressure Variability and the Prognosis of Ischemic Stroke With Intracranial Artery Stenosis', 'orgStudyIdInfo': {'id': 'RenJiH-20120804'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'amlodipine', 'description': 'The amlodipine - based antihypertensive treatment group (you can add a diuretic or other )', 'interventionNames': ['Drug: Amlodipine', 'Drug: Aspirin or Clopidogrel', 'Drug: Atorvastatin']}, {'type': 'EXPERIMENTAL', 'label': 'ACEI / ARB', 'description': 'ACEI / ARB -based antihypertensive treatment group ( you can add the B - blockers or other)', 'interventionNames': ['Drug: ACEI / ARB', 'Drug: Aspirin or Clopidogrel', 'Drug: Atorvastatin']}], 'interventions': [{'name': 'Amlodipine', 'type': 'DRUG', 'description': 'The amlodipine - based antihypertensive treatment group (you can add a diuretic or other )', 'armGroupLabels': ['amlodipine']}, {'name': 'ACEI / ARB', 'type': 'DRUG', 'description': 'ACEI / ARB -based antihypertensive treatment group ( you can add the B - blockers or other)', 'armGroupLabels': ['ACEI / ARB']}, {'name': 'Aspirin or Clopidogrel', 'type': 'DRUG', 'description': 'aspirin 100mg / d or Clopidogrel 75mg / d (anti-platelet agents)', 'armGroupLabels': ['ACEI / ARB', 'amlodipine']}, {'name': 'Atorvastatin', 'type': 'DRUG', 'description': 'Atorvastatin 10 - 40mg / d ( statin therapy)', 'armGroupLabels': ['ACEI / ARB', 'amlodipine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200127', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Guowen Shi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'RenJi Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Guowen Shi, MD', 'role': 'CONTACT', 'email': 'shigw228@126.com', 'phone': '86-13651932966'}], 'overallOfficials': [{'name': 'Guowen Shi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'RenJi Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RenJi Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Shi Guowen', 'investigatorAffiliation': 'RenJi Hospital'}}}}