AtherosclerosisNCT01150006
Correlation Between Various Adipokines and Vascular Inflammation Measured by Positron Emission Tomography (PET) With 18F-fluoro-deoxyglucose (FDG) (18FDG-PET)
An observational study of Atherosclerosis, run by Korea University at 1 site in South Korea.
Trial summary
The inflammatory state and composition of atherosclerotic plaques are considered the main contributing factors responsible for acute cardiovascular events, rather than the degree of stenosis. Read more about this study
- Who is it for?
- Ages 20 to 80 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Atherosclerosis
- What is being tested?
- Cross sectional study
- How many people
- 90 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2010to Jun 2010
- 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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy male participats who underwent a medical health check in the health promotion center in Korea Guro University
Who may be able to join
- Healthy male volunteers for visiting routine medical check in our clinic
Who cannot join
- History of cardiovascular disease (myocardial infarction, unstable angina,stroke, or cardiovascular revascularization)
- Diabetes
- Hypertension
- Malignancy
- Severe renal or hepatic disease
- Subjects taking medications that might affect inflammation such as NSIAD and statin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlation Between Various Adipokines and Vascular Inflammation Measured by 18FDG-PET In Healthy Male Subjects
The inflammatory state and composition of atherosclerotic plaques are considered the main contributing factors responsible for acute cardiovascular events, rather than the degree of stenosis. Recently, positron emission tomography (PET) with 18F-fluoro-deoxyglucose (FDG) has been suggested as a promising novel imaging technique to identify the inflammatory state of atherosclerotic plaque. Recently, a few clinical studies showed that circulating A-FABP level had a close relation with the development of atherosclerosis in human. Therefore, in the present study, the investigators examined the relationship between circulating A-FABP and vascular inflammation of carotid arteries measured using FDG-PET in healthy male subjects.
- Conditions
- Atherosclerosis
- Being tested
- Cross sectional study
- Keywords
- atherosclerosis, vascular inflammation, adipocyte fatty acid binding protein, adiponectin, leptin, 18FDG-PET
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cross sectional studyOther
This is not intervention study. The purpose of the study is to examine the relationship between various adipokine levels and PET imaging at the cross section setting
| Study group | Role | What they receive |
|---|---|---|
| Healthy male participants | Not described Receives: Other: Cross sectional study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vascular inflammation in carotid arterial wall, represented as the target-to-background ratio (TBR), using FDG-PET
Measured: 12 weeks
Secondary outcomes (4)
Circulating serum A-FABP levels
Measured: 12 weeks
Circulating serum leptin levels
Measured: 12weeks
Circulating serum adiponectin levels
Measured: 12 weeks
Carotid intima-media thickness levels measured using ultrasonography
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2010 (estimated)
- Study startApr 2010
- Primary completionJun 2010
- Study completionJun 2010
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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea University
- Sponsor type
- University, hospital or other
- Investigators
- Kyung Mook Choi, MD.PhD, Principal investigator, Korea University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01150006
- Sponsor's protocol ID
- PET_Adipokines
- Status last verified
- Apr 2010
- First submitted
- 9 Jun 2010
- Last updated
- 29 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Various Adipokines and Vascular Inflammation Measured by 18FDG-PET In Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01150006
- Acronym / sponsor ID
- PET_Adipokines
- Conditions
- Atherosclerosis
- Keywords
- atherosclerosis, vascular inflammation, adipocyte fatty acid binding protein, adiponectin, leptin, 18FDG-PET
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Korea UniversityUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 24 Jun 2010 (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.
The inflammatory state and composition of atherosclerotic plaques are considered the main contributing factors responsible for acute cardiovascular events, rather than the degree of stenosis. Recently, positron emission tomography (PET) with 18F-fluoro-deoxyglucose (FDG) has been suggested as a promising novel imaging technique to identify the inflammatory state of atherosclerotic plaque. Recently, a few clinical studies showed that circulating A-FABP level had a close relation with the development of atherosclerosis in human. Therefore, in the present study, the investigators examined the relationship between circulating A-FABP and vascular inflammation of carotid arteries measured using FDG-PET in healthy male subjects.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy male participants | – | Other: Cross sectional study |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy male participats who underwent a medical health check in the health promotion center in Korea Guro University
Key inclusion criteria (1 listed)
- Healthy male volunteers for visiting routine medical check in our clinic
Key exclusion criteria (6 listed)
- History of cardiovascular disease (myocardial infarction, unstable angina,stroke, or cardiovascular revascularization)
- Diabetes
- Hypertension
- Malignancy
- 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cross sectional studyThis is not intervention study. The purpose of the study is to examine the relationship between various adipokine levels and PET imaging at the cross section setting | Other | Healthy male participants |
Primary outcome
Vascular inflammation in carotid arterial wall, represented as the target-to-background ratio (TBR), using FDG-PET
Time frame: 12 weeks
4 secondary outcomes
Circulating serum A-FABP levels
Time frame: 12 weeks
Circulating serum leptin levels
Time frame: 12weeks
Circulating serum adiponectin levels
Time frame: 12 weeks
Carotid intima-media thickness levels measured using ultrasonography
Time frame: 12 weeks
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 29 Jun 2010.
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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.
Kyung Mook Choi, MD.PhD principal investigator
Korea University
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, 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 1 inclusion and 6 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 29 Jun 2010. 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?
Vascular inflammation in carotid arterial wall, represented as the target-to-background ratio (TBR), using FDG-PET (time frame: 12 weeks). 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 29 Jun 2010.