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

* 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.

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Key information

Conditions

Aging Angina Pectoris Cardiovascular Diseases Chest Pain Cognition Disorders Cognitive Dysfunction Heart Diseases Mental Disorders Mild Cognitive Impairment Myocardial Ischemia Neurocognitive Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

45 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Dunsan Oriental Hospital of Daejeon Univ.

Daejeon, 302122, South Korea

About this study

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,

additional demographic interview including covariate factors (depression status, marital status
vital sign check
the questionnaire for cognitive function
blood draw for genomic, proteomic, and metabolomic analyses (10 milli Liter), urine collection (20 milli Liter)
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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Sponsors and collaborators

Lead sponsor

Korea Institute of Oriental Medicine

Other Gov

Collaborators

Daejeon University

Registry information

Official study 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

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2013
First posted: May 3, 2012
Registry last updated: Apr 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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