Visit-to-Visit Variability in Blood Pressure as a Predictor of Poor Cognitive Function

NCT01688505 | Unknown

• 1 other identifier: BPV-Hallym
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Cerebral Small Vessel Diseases

Keywords

cerebral small vessel diseases; cognitive impairment; Blood pressure variability

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Association between raw score of K-MMSE and visit-to-visit diastolic BP variability

  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 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 from previous MRI documentation as small vessel disease to cognitive function evaluation; 1.5 to 7 years

Study Arms (1)

Visit-to-visit BP variability

The highest, intermediate, and the lowest visit-to-visit BP variability (Tertile grouping)

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Outpatients of stroke clinic in secondary or tertiary hospitals

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Hallym University Medical Center: lead

Study Sites (5)

Chuncheon Sacred Heart Hospital, Hallym University, College of Medicine

Chuncheon, Gangwon-do, 200-704, South Korea

RECRUITING

Hallym University Sacred Heart Hospital, Hallym University, College of Medicine

Anyang-si, Gyeonggi-do, 431-796, South Korea

RECRUITING

Gangdong Sacred Heart Hospital, Hallym University, College of Medicine

Seoul, 134-701, South Korea

RECRUITING

Hangang Sacred Heart Hospital, Hallym University, College of Medicine

Seoul, 150-719, South Korea

RECRUITING

Gangnam Sacred Heart Hospital, Hallym University, College of Medicine

Seoul, 150-950, South Korea

RECRUITING

MeSH Terms

Conditions

Cerebral Small Vessel Diseases; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Ju-Hun Lee, MD.

CONTACT

82 2 2224 6285; leejuhun@hallym.or.kr

Kyung-Ho Yu, MD. PhD.

CONTACT

ykh1030@hallym.or.kr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2012
• First Posted: September 20, 2012
• Study Start: May 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: September 20, 2012

Record last verified: 2012-09

Locations

KR (5)