AtherosclerosisNCT01589224
Risk Factor Analysis for Coronary Atherosclerosis Measured by MDCT
An observational study of Atherosclerosis and Metabolic Syndrome, run by Korea University at 1 site in South Korea.
Trial summary
Coronary MDCT (multi-detector computed tomography) has been useful screening imaging modality for the coronary artery disease. Recently, novel adipokines and hepatokines as well as various inflammatory markers have been known as direct regulators of atherosclerosis. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Atherosclerosis, Metabolic Syndrome
- How many people
- 150 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2012to Aug 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Apparently healthy people who underwent medical routine check up in Korea Helath Promotion Center.
Who may be able to join
- Apparently healthy people who underwent medical routine check up in Korea Health Promotion Center.
- age > 20 years
Who cannot join
- History of cardiovascular disease (myocardial infarction, unstable angina, stroke, or cardiovascular revascularization)
- Diabetes
- Stage 2 hypertension
- Severe renal or hepatic disease
Trial locations and contacts
1 site in 1 country.
About this study
Coronary MDCT (multi-detector computed tomography) has been useful screening imaging modality for the coronary artery disease. Recently, novel adipokines and hepatokines as well as various inflammatory markers have been known as direct regulators of atherosclerosis. Therefore, the investigators examine the correlation of various metabolic risk factors including adipokines and hepatokines with coronary atherosclerosis measured by coronary MDCT in apparently healthy people.
- Conditions
- Atherosclerosis, Metabolic Syndrome
- Medical subject headings
- Atherosclerosis, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy people | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
relation of adipokines and hepatokines with coronary atherosclerosis measured by MDCT
to examine the correlation of serum concentration of various adipokine such as adiponectin, resistin, A-FABP with coronary atheroslcerosis measured by MDCT as AGATSTON score, modified Gensini score
Measured: 3month
Secondary outcomes (2)
relation of adipokines and hepatokines with coronary atherosclerosis measured by MDCT
to examine the correlation of serum concentration of various hepatokines such as FGF-21, fetuin- A and selenoprotein P with coronary atheroslcerosis measured by MDCT as AGATSTON score, modified Gensini score
Measured: 3months
the correlation of various inflammatory markers with coronary atherosclerosis
Measured: 3months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2012 (estimated)
- Study startMay 2012
- Primary completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kyung Mook Choi, Korea University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01589224
- Sponsor's protocol ID
- KoreaHealth_MDCT
- Status last verified
- Apr 2012
- First submitted
- 24 Apr 2012
- Last updated
- 14 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factor Analysis for Coronary Atherosclerosis Measured by MDCT
- ClinicalTrials.gov ID
- NCT01589224
- Acronym / sponsor ID
- KoreaHealth_MDCT
- Conditions
- Atherosclerosis, Metabolic Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Korea UniversityUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Aug 2012 (actual)
- First posted
- 1 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Coronary MDCT (multi-detector computed tomography) has been useful screening imaging modality for the coronary artery disease. Recently, novel adipokines and hepatokines as well as various inflammatory markers have been known as direct regulators of atherosclerosis. Therefore, the investigators examine the correlation of various metabolic risk factors including adipokines and hepatokines with coronary atherosclerosis measured by coronary MDCT in apparently healthy people.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy people | – | – |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Apparently healthy people who underwent medical routine check up in Korea Helath Promotion Center.
Key inclusion criteria (2 listed)
- Apparently healthy people who underwent medical routine check up in Korea Health Promotion Center.
- age > 20 years
Key exclusion criteria (4 listed)
- History of cardiovascular disease (myocardial infarction, unstable angina, stroke, or cardiovascular revascularization)
- Diabetes
- Stage 2 hypertension
- Severe renal or hepatic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
relation of adipokines and hepatokines with coronary atherosclerosis measured by MDCT
Time frame: 3month
to examine the correlation of serum concentration of various adipokine such as adiponectin, resistin, A-FABP with coronary atheroslcerosis measured by MDCT as AGATSTON score, modified Gensini score
2 secondary outcomes
relation of adipokines and hepatokines with coronary atherosclerosis measured by MDCT
Time frame: 3months
the correlation of various inflammatory markers with coronary atherosclerosis
Time frame: 3months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atherosclerosis and Metabolic Syndrome, run by Korea University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
relation of adipokines and hepatokines with coronary atherosclerosis measured by MDCT (time frame: 3month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2015.