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

This study is currently recruiting participants.
Verified May 2012 by Korea Institute of Oriental Medicine
Sponsor:
Collaborator:
Daejeon University
Information provided by (Responsible Party):
Dal-Seok Oh, OMD, PhD, Korea Institute of Oriental Medicine
ClinicalTrials.gov Identifier:
NCT01590706
First received: May 1, 2012
Last updated: NA
Last verified: May 2012
History: No changes posted
  Purpose
  • 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.

Condition
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by 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
Estimated Study Completion Date: March 2013
Estimated 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.
  Eligibility

Ages Eligible for Study:   45 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Healthy middle aged (45-64 age) and elderly (over 65 age) person

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01590706

Contacts
Contact: Sunha Park, RN -82-42-868-9671 sunha22@kiom.re.kr
Contact: Ho-Ryong Yoo, OMD, PhD -82-42-470-9232 medicdragon@hanmail.net

Locations
Korea, Republic of
Dunsan Oriental Hospital of Daejeon Univ. Recruiting
Daejeon, Korea, Republic of, 302122
Contact: In-Kyung Baek, OMD     -82-42-470-9003        
Sponsors and Collaborators
Korea Institute of Oriental Medicine
Daejeon University
Investigators
Study Director: Miyoung Lee, PhD Korea Institute of Oriental Medicine
  More Information

No publications provided

Responsible Party: Dal-Seok Oh, OMD, PhD, Senior Investigator, Korea Institute of Oriental Medicine
ClinicalTrials.gov Identifier: NCT01590706     History of Changes
Other Study ID Numbers: KC1101
Study First Received: May 1, 2012
Last Updated: May 1, 2012
Health Authority: South Korea: Ministry of Education, Science, and Technology

Keywords provided by Korea Institute of Oriental Medicine:
Genotype-Phenotype Association
Aged
Middle Aged
 Mild Cognitive Impairment
Heart Rate Control
Biomarkers

Additional relevant MeSH terms:
Angina Pectoris
Cognition Disorders
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
 Chest Pain
Pain
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 23, 2013