Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2026-01-01 @ 4:59 AM
Study NCT ID:
NCT01688505
Status:
UNKNOWN
Last Update Posted:
2012-09-20
First Post:
2012-09-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Visit-to-Visit Variability in Blood Pressure as a Predictor of Poor Cognitive Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059345', 'term': 'Cerebral Small Vessel Diseases'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}], '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': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2013-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-09-19', 'studyFirstSubmitDate': '2012-09-16', 'studyFirstSubmitQcDate': '2012-09-19', 'lastUpdatePostDateStruct': {'date': '2012-09-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-09-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Association between raw score of K-MMSE and visit-to-visit systolic BP variability', 'timeFrame': 'Time from previous MRI documentation as small vessel disease to cognitive function evaluation; 1.5 to 7 years', 'description': 'Difference of mean K-MMSE raw scores between the highest and the lowest tertile group stratified by visit-to-visit systolic BP variability: Wilcoxon\\_Mann\\_Whitney test\n\nBinary logistic regression analysis for independent association between visit-to-visit systolic BP variability and low cognition, including confounding variables with p\\<0.2 in univariate analysis (Low cognition, defined as the lowest tertile of K-MMSE raw score)'}], 'secondaryOutcomes': [{'measure': 'Association between raw score of K-MMSE and visit-to-visit diastolic BP variability', 'timeFrame': 'Time from previous MRI documentation as small vessel disease to cognitive function evaluation; 1.5 to 7 years', 'description': 'Difference of mean K-MMSE raw scores between the highest and the lowest tertile group stratified by visit-to-visit diastolic BP variability: Wilcoxon\\_Mann\\_Whitney test\n\nBinary logistic regression analysis for independent association between visit-to-visit diastolic BP variability and low cognition, including confounding variables with p\\<0.2 in univariate analysis (Low cognition, defined as the lowest tertile of K-MMSE raw score)'}, {'measure': 'Association between raw scores of "K-VCI NP 30-minute protocol" sub-tests and visit-to-visit systolic BP variability', 'timeFrame': 'Time from previous MRI documentation as small vessel disease to cognitive function evaluation; 1.5 to 7 years', 'description': 'Difference of mean "K-VCI NP 30-minute protocol" sub-tests\' raw scores between the highest and the lowest tertile group stratified by visit-to-visit systolic BP variability: Wilcoxon\\_Mann\\_Whitney test\n\nBinary logistic regression analysis for independent association between visit-to-visit systolic BP variability and low cognition, including confounding variables with p\\<0.2 in univariate analysis (Low cognition, defined as the lowest tertile of each "K-VCI NP 30-minute protocol" sub-test)\n\n"K-VCIHS NP 30-minute protocol" include Seoul Verbal Learning Test (SVLT), Semantic Fluency Test, Animal Phonemic Fluency Test, Digit Symbol-Coding (DSC), Geriatric Depression Scale (GDS), and Trail Making Test A \\& B.'}, {'measure': 'Association between raw scores of "K-VCI NP 30-minute protocol" sub-tests and visit-to-visit diastolic BP variability', 'timeFrame': 'Time from previous MRI documentation as small vessel disease to cognitive function evaluation; 1.5 to 7 years', 'description': 'Difference of mean "K-VCI NP 30-minute protocol" sub-tests\' raw scores between the highest and the lowest tertile group stratified by visit-to-visit diastolic BP variability: Wilcoxon\\_Mann\\_Whitney test\n\nBinary logistic regression analysis for independent association between visit-to-visit diastolic BP variability and low cognition, including confounding variables with p\\<0.2 in univariate analysis (Low cognition, defined as the lowest tertile of each "K-VCI NP 30-minute protocol" sub-test)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cerebral small vessel diseases', 'cognitive impairment', 'Blood pressure variability'], 'conditions': ['Cerebral Small Vessel Diseases']}, 'descriptionModule': {'briefSummary': 'Hypertension in midlife is an independent risk factor of late life cognitive dysfunction or dementia. Chronic hypertension cause vascular damage and cerebral ischemia, which ultimately gives rise to the cognitive dysfunction or dementia.\n\nA recent study showed that high visit-to-visit variability in clinic systolic blood pressure (BP) was a strong independent predictor of stroke. This finding suggests that high clinic systolic BP variability itself as well as chronic hypertension may cause vascular damage and cerebral ischemia. Therefore, high clinic SBP variability may be also an independent risk factor of cognitive dysfunction or dementia.\n\nVascular damage leads to the diminished autoregulatory capacities of cerebral arteries. The brain with the reduced autoregulatory capacity may be more vulnerable to BP fluctuation. Therefore, high BP variability may be more harmful in patients with damaged vessels (for example, in patients with cerebral small vessel disease).\n\nPrevious data about BP variability and cognition revealed very controversial. Some studies showed poor cognition in patients with high BP variability, but others did not.\n\nThe previous studies were mostly based on cross-sectional designs, and performed in small-sized heterogeneous population for primary prevention. The harmful effect of high BP variability may be clearer in the population with damaged vascular bed, such as cerebral small vessel disease. The previous studies usually used ambulatory BP monitoring (ABPM). However, recent data suggested that variability in BP on ABPM may be a weaker predictor of vascular events than be visit-to-visit variability in clinic BP.\n\nThe investigators sought to find whether high visit-to-visit variability in clinic BP is related with poor cognitive function in patients with cerebral small vessel disease.', 'detailedDescription': "This is a retrospective cohort study.\n\nWe include patients with cerebral small vessel disease, documented on MRI from Jan 2006 to Dec 2010, who have been regularly followed up.\n\nWe evaluate the patients' cognitive function after written informed consent.\n\nWe independently review patients' medical record and analyze MRI data. BP variability parameters include standard deviation(SD, primary measuring parameter), coefficient of variation, successive variation, average real variability (ARV), SD independent of mean(SDIM), SV independent of mean(SVIM), and ARV independent of mean (ARVIM). We will adjust following confounding variables: age, sex, level of education, vascular risk factors, mean SBP and DBP, NIHSS score, and white matter lesion burden on T2-weighted MRI."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '60 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Outpatients of stroke clinic in secondary or tertiary hospitals', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with cerebral small vessel disease previously documented on MRI (definition of small vessel disease - symptomatic lacunar infarction or white matter ischemic lesion with one or more asymptomatic lacunes)\n\nExclusion Criteria:\n\n* Incomplete clinic BP data (less than 6 BP readings during recent one year)\n* History of cardiovascular or cerebrovascular events during recent one year\n* Documented cerebral infarction from large artery atherosclerosis\n* Atrial fibrillation or cardiac disease with high risk of embolism\n* Significant medical, neurological, or psychiatric disease affecting cognition\n* Known dementia treated with acetylcholine esterase inhibitor or memantine\n* Patients without informed consent'}, 'identificationModule': {'nctId': 'NCT01688505', 'acronym': 'BPV-COG', 'briefTitle': 'Visit-to-Visit Variability in Blood Pressure as a Predictor of Poor Cognitive Function', 'organization': {'class': 'OTHER', 'fullName': 'Hallym University Medical Center'}, 'officialTitle': 'Multicenter Retrospective Study of Visit-to-Visit Variability in Blood Pressure as a Predictor of Poor Cognitive Function', 'orgStudyIdInfo': {'id': 'BPV-Hallym'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Visit-to-visit BP variability', 'description': 'The highest, intermediate, and the lowest visit-to-visit BP variability (Tertile grouping)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '200-704', 'city': 'Chuncheon', 'state': 'Gangwon-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Hui-Chul Choi, MD. PhD.', 'role': 'CONTACT', 'email': 'dohchi@hallym.or.kr'}, {'name': 'Chul-Ho Kim, MD.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Chuncheon Sacred Heart Hospital, Hallym University, College of Medicine', 'geoPoint': {'lat': 37.87472, 'lon': 127.73417}}, {'zip': '431-796', 'city': 'Anyang-si', 'state': 'Gyeonggi-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Byung-Chul Lee, MD. PhD.', 'role': 'CONTACT', 'email': 'ssbrain@hallym.or.kr'}, {'name': 'Kyung-Ho Yu, MD. PhD.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Mi-Sun Oh, MD.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hallym University Sacred Heart Hospital, Hallym University, College of Medicine', 'geoPoint': {'lat': 37.3925, 'lon': 126.92694}}, {'zip': '134-701', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Ju-Hun Lee, MD.', 'role': 'CONTACT', 'email': 'leejuhun@hallym.or.kr', 'phone': '82 2 2224 2695'}, {'name': 'Joon-Hyun Shin, MD.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Gangdong Sacred Heart Hospital, Hallym University, College of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '150-719', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Soo-Jin Cho, MD. PhD.', 'role': 'CONTACT', 'email': 'soojinc@hallym.or.kr'}, {'name': 'Yang-Ki Minn, MD. PhD.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hangang Sacred Heart Hospital, Hallym University, College of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '150-950', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'San Jung, MD.', 'role': 'CONTACT', 'email': 'neurojs@hallym.or.kr'}], 'facility': 'Gangnam Sacred Heart Hospital, Hallym University, College of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Ju-Hun Lee, MD.', 'role': 'CONTACT', 'email': 'leejuhun@hallym.or.kr', 'phone': '82 2 2224 6285'}, {'name': 'Kyung-Ho Yu, MD. PhD.', 'role': 'CONTACT', 'email': 'ykh1030@hallym.or.kr'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hallym University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}