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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01688505
Other study ID # BPV-Hallym
Secondary ID
Status Recruiting
Phase N/A
First received September 16, 2012
Last updated September 19, 2012
Start date May 2012
Est. completion date February 2013

Study information

Verified date September 2012
Source Hallym University Medical Center
Contact Ju-Hun Lee, MD.
Phone 82 2 2224 6285
Email leejuhun@hallym.or.kr
Is FDA regulated No
Health authority Korea: Institutional Review BoardKorea: Food and Drug Administration
Study type Observational

Clinical 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.

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 140
Est. completion date February 2013
Est. primary completion date February 2013
Accepts healthy volunteers No
Gender Both
Age group 60 Years to 80 Years
Eligibility Inclusion Criteria:

- 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)

Exclusion Criteria:

- 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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective


Related Conditions & MeSH terms


Locations

Country Name City State
Korea, Republic of Hallym University Sacred Heart Hospital, Hallym University, College of Medicine Anyang-si Gyeonggi-do
Korea, Republic of Chuncheon Sacred Heart Hospital, Hallym University, College of Medicine Chuncheon-si Gangwon-do
Korea, Republic of Gangdong Sacred Heart Hospital, Hallym University, College of Medicine Seoul
Korea, Republic of Gangnam Sacred Heart Hospital, Hallym University, College of Medicine Seoul
Korea, Republic of Hangang Sacred Heart Hospital, Hallym University, College of Medicine Seoul

Sponsors (1)

Lead Sponsor Collaborator
Hallym University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
Time from previous MRI documentation as small vessel disease to cognitive function evaluation; 1.5 to 7 years No
Secondary 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)
Time from previous MRI documentation as small vessel disease to cognitive function evaluation; 1.5 to 7 years No
Secondary 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.
Time from previous MRI documentation as small vessel disease to cognitive function evaluation; 1.5 to 7 years No
Secondary 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)
Time from previous MRI documentation as small vessel disease to cognitive function evaluation; 1.5 to 7 years No
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