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A Study of Characterizing Cognitive Decline and Functional Cardiac Senescence in Healthy Korean Volunteers

This study has been completed.
Daejeon University
Information provided by (Responsible Party):
Dal-Seok Oh, OMD, PhD, Korea Institute of Oriental Medicine Identifier:
First received: May 1, 2012
Last updated: April 1, 2014
Last verified: April 2014
  • Although aging process appears to be generally characterized, investigators have been paid much attention to the specific target molecules, which leads to discover the clinical markers of the senescence. The present study is to investigate the clinical and biological profile of cognitive decline and functional cardiac senescence in healthy middle aged and elderly Korean volunteers.
  • This study was conducted as a cross-sectional, single-center, comparative clinical study.
  • Each volunteer was given informed consent for checking cognition and cardiac function. Blood and urine samples were collected to analyze genome, proteome, and metabolome to assess cognition and cardiac function of its muscle enzymes.

Aging Mild Cognitive Impairment Angina Pectoris

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: An Association Study of Characterizing Cognitive Decline and Functional Cardiac Senescence Profile Through the Association of Biomarkers and Clinical Outcomes in Healthy Middle Aged and Elderly Korean Volunteers

Further study details as provided by Dal-Seok Oh, OMD, PhD, Korea Institute of Oriental Medicine:

Biospecimen Retention:   Samples With DNA
Samples for single nucleotide polymorphism, and for cardiac enzyme level detection

Estimated Enrollment: 116
Study Start Date: November 2011
Study Completion Date: March 2013
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Detailed Description:
  • The protocol of this study was developed as the first assessment of the three to four series of clinical research on senescence.
  • This design of the study is a non-interventional, single-center, single-visit design for investigating the cognitive decline and cardiac function including heart muscle enzyme activity, which have been considered one of the key points in aging process.
  • Volunteers visit the study site during the screening period, informed consent for study participation and blood draw are given respectively, then, the eligibilities are met, participants visit the study site just once within two weeks.
  • The participants undergo the following five procedures for 2-3 hours; out-patient visit,

    1. additional demographic interview including covariate factors (depression status, marital status
    2. vital sign check
    3. the questionnaire for cognitive function
    4. blood draw for genomic, proteomic, and metabolomic analyses (10 milli Liter), urine collection (20 milli Liter)
    5. electrocardiogram (ECG), then they are discharged.
  • Their safety follow-up is monitored in a week (± 1 day) by a phone-call from the study associates.
  • To evaluate cognitive function, several cognitive batteries were used, 3MSE (Modified-Mini Mental State Examination), ADAS-cog (Alzheimer's Disease Assessment Scale-cognitive subscale); for cognitive biomarkers, Apolipoprotein E, Type-3 metabotropic glutamate receptors.
  • To evaluate cardiac function including its enzyme activity: HRV (heart rate variability), CRP (c-reactive protein); Cardiac Troponin T.

Ages Eligible for Study:   45 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Healthy middle aged (45-64 age) and elderly (over 65 age) person

Inclusion Criteria:

  • Healthy subjects >= 45 and <= 80 years of age
  • who understands the study procedures signs informed consent forms

Exclusion Criteria:

  • who > 150 mmHg in systolic or < 95 mmHg in diastolic blood pressure
  • who > 110 mg/dl in fast glucose level
  • Smoking > 20 cigarettes/day
  • Alcohol > 3 units/day (1 unit = pure alcohol 10 milli Liter)
  • Caffeine > 5 cups of coffee or tea/day
  Contacts and Locations
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Please refer to this study by its identifier: NCT01590706

Korea, Republic of
Dunsan Oriental Hospital of Daejeon Univ.
Daejeon, Korea, Republic of, 302122
Sponsors and Collaborators
Korea Institute of Oriental Medicine
Daejeon University
Study Director: Miyoung Lee, PhD Korea Institute of Oriental Medicine
  More Information

Responsible Party: Dal-Seok Oh, OMD, PhD, Senior Investigator, Korea Institute of Oriental Medicine Identifier: NCT01590706     History of Changes
Other Study ID Numbers: KC1101
Study First Received: May 1, 2012
Last Updated: April 1, 2014

Keywords provided by Dal-Seok Oh, OMD, PhD, Korea Institute of Oriental Medicine:
Genotype-Phenotype Association
Middle Aged
Mild Cognitive Impairment
Heart Rate Control

Additional relevant MeSH terms:
Cognition Disorders
Mild Cognitive Impairment
Angina Pectoris
Neurocognitive Disorders
Mental Disorders
Chest Pain
Neurologic Manifestations
Nervous System Diseases
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Signs and Symptoms processed this record on June 23, 2017