Suspended

BPV-COGMulticenter Retrospective Study of Visit-to-Visit Variability in Blood Pressure as a Predictor of Poor Cognitive Function

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What is being collected

Data Collection

Collected from past medical records and data - Retrospective
Who is being recruted

Mental Disorders+8

+ Brain Diseases

+ Cardiovascular Diseases

From 60 to 80 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: May 2012
See protocol details

Summary

Principal SponsorHallym University Medical Center
Study ContactJu-Hun Lee, MD.More contacts
Last updated: September 20, 2012
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01688505
Principal SponsorHallym University Medical Center
Study ContactJu-Hun Lee, MD.More contacts
Last updated: September 20, 2012
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

140 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 60 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Mental DisordersBrain DiseasesCardiovascular DiseasesCentral Nervous System DiseasesCerebrovascular DisordersCognition DisordersNervous System DiseasesVascular DiseasesNeurocognitive DisordersCerebral Small Vessel DiseasesCognitive Dysfunction

Criteria

1 inclusion criteria required to participate
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)
7 exclusion criteria prevent from participating
Atrial fibrillation or cardiac disease with high risk of embolism
Documented cerebral infarction from large artery atherosclerosis
History of cardiovascular or cerebrovascular events during recent one year
Incomplete clinic BP data (less than 6 BP readings during recent one year)
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 5 locations

Recruiting

Chuncheon Sacred Heart Hospital, Hallym University, College of Medicine

Chuncheon, South KoreaOpen Chuncheon Sacred Heart Hospital, Hallym University, College of Medicine in Google Maps
Recruiting

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

Anyang-si, South Korea
Recruiting

Gangdong Sacred Heart Hospital, Hallym University, College of Medicine

Seoul, South Korea
Recruiting

Hangang Sacred Heart Hospital, Hallym University, College of Medicine

Seoul, South Korea
Suspended5 Study Centers