Visit-to-Visit Variability in Blood Pressure as a Predictor of Poor Cognitive Function
NCT ID: NCT01688505
Last Updated: 2012-09-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
140 participants
OBSERVATIONAL
2012-05-31
2013-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
A 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.
Vascular 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).
Previous data about BP variability and cognition revealed very controversial. Some studies showed poor cognition in patients with high BP variability, but others did not.
The 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.
The 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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
We include patients with cerebral small vessel disease, documented on MRI from Jan 2006 to Dec 2010, who have been regularly followed up.
We evaluate the patients' cognitive function after written informed consent.
We 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
RETROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Visit-to-visit BP variability
The highest, intermediate, and the lowest visit-to-visit BP variability (Tertile grouping)
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* History of cardiovascular or cerebrovascular events during recent one year
* Documented cerebral infarction from large artery atherosclerosis
* Atrial fibrillation or cardiac disease with high risk of embolism
* Significant medical, neurological, or psychiatric disease affecting cognition
* Known dementia treated with acetylcholine esterase inhibitor or memantine
* Patients without informed consent
60 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hallym University Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Chuncheon Sacred Heart Hospital, Hallym University, College of Medicine
Chuncheon, Gangwon-do, South Korea
Hallym University Sacred Heart Hospital, Hallym University, College of Medicine
Anyang-si, Gyeonggi-do, South Korea
Gangdong Sacred Heart Hospital, Hallym University, College of Medicine
Seoul, , South Korea
Hangang Sacred Heart Hospital, Hallym University, College of Medicine
Seoul, , South Korea
Gangnam Sacred Heart Hospital, Hallym University, College of Medicine
Seoul, , South Korea
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Hui-Chul Choi, MD. PhD.
Role: primary
Byung-Chul Lee, MD. PhD.
Role: primary
Ju-Hun Lee, MD.
Role: primary
Soo-Jin Cho, MD. PhD.
Role: primary
San Jung, MD.
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
BPV-Hallym
Identifier Type: -
Identifier Source: org_study_id