Cerebral Small Vessel DiseasesBPV-COGNCT01688505
Visit-to-Visit Variability in Blood Pressure as a Predictor of Poor Cognitive Function
An observational study of Cerebral Small Vessel Diseases, run by Hallym University Medical Center at 5 sites in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Cerebral Small Vessel Diseases
- How many people
- 140 participants
- Where
- 5 sitesSouth Korea
- Study dates
- May 2012to Feb 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Outpatients of stroke clinic in secondary or tertiary hospitals
Who may be able to join
- 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)
Who cannot join
- Incomplete clinic BP data (less than 6 BP readings during recent one year)
- 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
Trial locations and contacts
5 sites in 1 country.
Kyung-Ho Yu, MD. PhD. contact
5 sites in 1 country
South Korea5 sites, 5 recruiting
- Recruiting
Hallym University Sacred Heart Hospital, Hallym University, College of Medicine
Anyang-si, Gyeonggi-do, 431-796
Byung-Chul Lee, MD. PhD., ssbrain@hallym.or.kr
Kyung-Ho Yu, MD. PhD.
- Recruiting
Chuncheon Sacred Heart Hospital, Hallym University, College of Medicine
Chuncheon, Gangwon-do, 200-704
Hui-Chul Choi, MD. PhD., dohchi@hallym.or.kr
Chul-Ho Kim, MD.
- Recruiting
Gangdong Sacred Heart Hospital, Hallym University, College of Medicine
Seoul, 134-701
Ju-Hun Lee, MD., 82 2 2224 2695, leejuhun@hallym.or.kr
Joon-Hyun Shin, MD.
- Recruiting
Hangang Sacred Heart Hospital, Hallym University, College of Medicine
Seoul, 150-719
Soo-Jin Cho, MD. PhD., soojinc@hallym.or.kr
Yang-Ki Minn, MD. PhD.
- Recruiting
Gangnam Sacred Heart Hospital, Hallym University, College of Medicine
Seoul, 150-950
San Jung, MD., neurojs@hallym.or.kr
About this study
Official title: Multicenter Retrospective Study of Visit-to-Visit Variability in Blood Pressure as a Predictor of Poor Cognitive Function
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.
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.
Read more
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.
Read the detailed description
This is a retrospective cohort study.
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
- Cerebral Small Vessel Diseases
- Keywords
- cerebral small vessel diseases, cognitive impairment, Blood pressure variability
- Medical subject headings
- Cerebral Small Vessel Diseases, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Visit-to-visit BP variability | The highest, intermediate, and the lowest visit-to-visit BP variability (Tertile grouping) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between raw score of K-MMSE and visit-to-visit systolic BP variability
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
Binary 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)
Measured: Time from previous MRI documentation as small vessel disease to cognitive function evaluation; 1.5 to 7 years
Secondary outcomes (3)
Association between raw score of K-MMSE and visit-to-visit diastolic BP variability
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
Binary 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)
Measured: Time from previous MRI documentation as small vessel disease to cognitive function evaluation; 1.5 to 7 years
Association between raw scores of "K-VCI NP 30-minute protocol" sub-tests and visit-to-visit systolic BP variability
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
Binary 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)
"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.
Measured: Time from previous MRI documentation as small vessel disease to cognitive function evaluation; 1.5 to 7 years
Association between raw scores of "K-VCI NP 30-minute protocol" sub-tests and visit-to-visit diastolic BP variability
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
Binary 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)
Measured: Time from previous MRI documentation as small vessel disease to cognitive function evaluation; 1.5 to 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2012 (estimated)
- Study startMay 2012
- Primary completionFeb 2013 (estimated)
- Study completionFeb 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Small Vessel DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hallym University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01688505
- Sponsor's protocol ID
- BPV-Hallym
- Acronym
- BPV-COG
- Status last verified
- Sep 2012
- First submitted
- 16 Sep 2012
- Last updated
- 20 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Retrospective Study of Visit-to-Visit Variability in Blood Pressure as a Predictor of Poor Cognitive Function
- ClinicalTrials.gov ID
- NCT01688505
- Acronym / sponsor ID
- BPV-COG / BPV-Hallym
- Conditions
- Cerebral Small Vessel Diseases
- Keywords
- cerebral small vessel diseases, cognitive impairment, Blood pressure variability
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Hallym University Medical CenterUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Feb 2013 (estimated)
- Study completion
- Feb 2013 (estimated)
- First posted
- 20 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
This is a retrospective cohort study.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Visit-to-visit BP variability | – | –The highest, intermediate, and the lowest visit-to-visit BP variability (Tertile grouping) |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatients of stroke clinic in secondary or tertiary hospitals
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (7 listed)
- Incomplete clinic BP data (less than 6 BP readings during recent one year)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Association between raw score of K-MMSE and visit-to-visit systolic BP variability
Time frame: Time from previous MRI documentation as small vessel disease to cognitive function evaluation; 1.5 to 7 years
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 Binary 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)
3 secondary outcomes
Association between raw score of K-MMSE and visit-to-visit diastolic BP variability
Time frame: Time from previous MRI documentation as small vessel disease to cognitive function evaluation; 1.5 to 7 years
Association between raw scores of "K-VCI NP 30-minute protocol" sub-tests and visit-to-visit systolic BP variability
Time frame: Time from previous MRI documentation as small vessel disease to cognitive function evaluation; 1.5 to 7 years
Association between raw scores of "K-VCI NP 30-minute protocol" sub-tests and visit-to-visit diastolic BP variability
Time frame: Time from previous MRI documentation as small vessel disease to cognitive function evaluation; 1.5 to 7 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyung-Ho Yu, MD. PhD. contact
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Small Vessel Diseases, run by Hallym University Medical Center at 5 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ju-Hun Lee, MD. (82 2 2224 6285, leejuhun@hallym.or.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between raw score of K-MMSE and visit-to-visit systolic BP variability (time frame: Time from previous MRI documentation as small vessel disease to cognitive function evaluation; 1.5 to 7 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2012; AzTrials last refreshed its copy on 2 Nov 2026.