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CompletedNCT01590706Updated Apr 2, 2014

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

An observational study in Aging, Mild Cognitive Impairment and Angina Pectoris, sponsored by Korea Institute of Oriental Medicine. Completed at 1 site in Korea, Republic of. Open to participants aged 45 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-04-02.

Sponsored by Korea Institute of Oriental Medicine · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
116
Ages
45 Years to 80 Years
Sex
All
01

Study summary

  • 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.
Read the 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.
02

Conditions studied

  • Aging
  • Mild Cognitive Impairment
  • Angina Pectoris

Keywords

  • Genotype-Phenotype Association
  • Aged
  • Middle Aged
  • Mild Cognitive Impairment
  • Heart Rate Control
  • Biomarkers
03

In context

Angina Pectoris

519 studies on the registry are indexed under Angina Pectoris; 82 are open to participants now.

This study's planned enrollment of 116 is below the median of 591 across 154 observational studies indexed under Angina Pectoris.

Browse Angina Pectoris studies →

Lead sponsor

Korea Institute of Oriental Medicine is the lead sponsor of 11 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 80 Years
Sexes eligible
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

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
05

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
116 participants (estimated)
Biospecimen retention
Samples with dna
06

Study locations

1 site
  • Dunsan Oriental Hospital of Daejeon Univ.
    Daejeon, 302122, Korea, Republic of
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 2, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT01590706
Lead sponsor
Korea Institute of Oriental Medicine
Collaborators
Daejeon University
Responsible party
Dal-Seok Oh, OMD, PhD (Senior Investigator, Korea Institute of Oriental Medicine) — Principal investigator
First posted
May 3, 2012
Start date
Nov 2011
Primary completion
Oct 2012
Completion
Mar 2013
Last update
Apr 2, 2014

Study contacts

Miyoung Lee, PhD
study director · Korea Institute of Oriental Medicine

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.

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