Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2026-02-13 @ 4:13 PM
Study NCT ID:
NCT02663557
Status:
COMPLETED
Last Update Posted:
2017-05-19
First Post:
2016-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Influence of day-to Day BPV on Long-term Adverse Outcomes in Patients Ischemic Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 400}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-18', 'studyFirstSubmitDate': '2016-01-21', 'studyFirstSubmitQcDate': '2016-01-21', 'lastUpdatePostDateStruct': {'date': '2017-05-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-01-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'non-cardiovascular events', 'timeFrame': '12 months', 'description': 'fall,frature and other unexpected adverse events'}], 'primaryOutcomes': [{'measure': 'mortality', 'timeFrame': '12 months', 'description': 'all cause death'}], 'secondaryOutcomes': [{'measure': 'macrovascular events', 'timeFrame': '12 months', 'description': 'stroke, including recurrent ischemic stroke and intra-cerebral hemorrhage, coronary artery events and peripheral artery occlusion'}, {'measure': 'microvascular events', 'timeFrame': '12 months', 'description': 'cognition and psychological decline'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['stroke, blood pressure, prognosis'], 'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'Stroke is one of the most devastating disorder worldwide. Hypertension has been confirmed to be a major modifiable risk factor for stroke.Even the casual visit hypertension has been managed ideally,there is still surplus risk for stroke re-attack.The purpose of this study is to explore whether variation of 24-hour ambulatory and visit-to-visit blood pressure variability (BPV) contribute to recurrent stroke.', 'detailedDescription': 'System hypertension has been reported to play the most important role in the development of stroke,and the anti-hypertension therapy is regarded as the cornerstone for stroke secondary prevention. However, even though some proper measures have been taken,there is still surplus risk for recurrent stroke. Recently the variation of system blood pressure has been focused as the candidate of another risk factor.Up to date,this hypothesis remains an intense debate and few studies has been done to clarify it.Besides, the definition of BPV and measurement of BPV parameters are still beyond conformity.In the current study, the long-term and short-term BPV will be taken respectively for patients with prior stroke. Bsed on these parameters, the cohort will be followed up for average 2 years. The predefined outcome include composite cardiovascular events, neuropsychiatric wording, and mortality during followup.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with acute ischemic stroke, which should be verified by define radiological evidences and acute onset of clinical manifestations.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\-\n\nExclusion Criteria:\n\n* comorbidity of dementia ( including AD, PDD, FTLD, VaD and so on )\n* coexisting severe systematic diseases on admission such as acute coronary syndrome, malignant tumor, plasma dialysis therapy for renal failure, cirrhosis, rheumatic disease that would influence mortality.\n* discharge with severe sequelae with mRS\\>5'}, 'identificationModule': {'nctId': 'NCT02663557', 'briefTitle': 'The Influence of day-to Day BPV on Long-term Adverse Outcomes in Patients Ischemic Stroke', 'organization': {'class': 'OTHER_GOV', 'fullName': "Dongguan People's Hospital"}, 'officialTitle': 'Evaluating the Influence of Day-to-day Blood Pressure Variation in Acute Ischemic Stroke on Adverse Outcomes in Long-term Post-stroke Followup', 'orgStudyIdInfo': {'id': '2008105150027'}, 'secondaryIdInfos': [{'id': '2008105150027', 'type': 'OTHER', 'domain': 'dongguan sci and tech bureau'}, {'id': 'A2013836', 'type': 'OTHER_GRANT', 'domain': 'guangdong province medical science and research fund'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'non-hypertension with lower BPV', 'description': 'patients meeting to flowing two criteria: 1. mean SBP\\<140 mmHg; 2. Systolic blood pressure-coefficient variation (SBP-CV) \\< Median SBP-CV'}, {'label': 'non-hypertension with higher BPV', 'description': 'patients meeting to flowing two criteria: 1. mean SBP\\< 140 mmHg; 2. SBP-CV \\> Median SBP-CV'}, {'label': 'hypertension with lower BPV', 'description': 'patients meeting to flowing two criteria: 1. mean SBP\\> 140 mmHg; 2. SBP-CV \\< Median SBP-CV'}, {'label': 'hypertension with higher BPV', 'description': 'patients meeting to flowing two criteria: 1. mean SBP\\> 140 mmHg; 2. SBP-CV \\> Median SBP-CV'}]}, 'contactsLocationsModule': {'locations': [{'zip': '523029', 'city': 'Dongguan', 'state': 'Guangdong', 'country': 'China', 'facility': "Dongguan Peoples' Hospital", 'geoPoint': {'lat': 23.01797, 'lon': 113.74866}}], 'overallOfficials': [{'name': 'Zhu Shi, MD,PhD', 'role': 'STUDY_CHAIR', 'affiliation': "dongguan peoples' hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The data will not be shared with respect to the privacy of patients info.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhu Shi', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'deputy director of neurology department', 'investigatorFullName': 'Zhu Shi', 'investigatorAffiliation': "Dongguan People's Hospital"}}}}