AtherosclerosisNCT01150019
Correlation Between Circulating Resistin and Vascular Inflammation Measured by 18F-fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) (18FDG-PET)
An observational study of Atherosclerosis, run by Korea University at 1 site in South Korea.
Trial summary
Vascular inflammation is a key factor in both the pathogenesis and outcome of atherosclerosis.Resistin was shown to induce vascular endothelial dysfunction and vascular smooth muscle cell proliferation. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Atherosclerosis
- What is being tested?
- Cross sectional study
- How many people
- 120 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy participats who underwent a medical health check in the health promotion center in Korea Guro University
Who may be able to join
- Healthy 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 non-steroidal anti-inflammatory drugs (NSAIDs) and statin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlation Between Circulating Resistin and Vascular Inflammation Measured by 18FDG-PET in Obese Person
Vascular inflammation is a key factor in both the pathogenesis and outcome of atherosclerosis.Resistin was shown to induce vascular endothelial dysfunction and vascular smooth muscle cell proliferation.
18F-fluorodeoxyglucose (FDG) positron emission tomography (PET) is a promising tool for identifying and quantifying vascular inflammation within atherosclerotic plaques.Therefore, the purpose of the study is to demonstrate the correlation between circulating resistin and vascular inflammation detected by 18FDG-PET in obese persons.
- Conditions
- Atherosclerosis
- Being tested
- Cross sectional study
- Keywords
- atherosclerosis, vascular inflammation, resistin, adiponectin, 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 |
|---|---|---|
| Obese Group | Not described Receives: Other: Cross sectional study | |
| Non Obese Group | 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 (3)
Circulating serum adiponectin levels
Measured: 12 weeks
carotid intima-media thickness levels measured using ultrasonography
Measured: 12 weeks
Circulating serum resistin levels
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-control
- Time perspective
- Cross-sectional
- Enrolment
- 120 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
- NCT01150019
- Sponsor's protocol ID
- PET_Resistin
- Status last verified
- Apr 2010
- First submitted
- 9 Jun 2010
- Last updated
- 8 Jul 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Circulating Resistin and Vascular Inflammation Measured by 18FDG-PET in Obese Person
- ClinicalTrials.gov ID
- NCT01150019
- Acronym / sponsor ID
- PET_Resistin
- Conditions
- Atherosclerosis
- Keywords
- atherosclerosis, vascular inflammation, resistin, adiponectin, 18FDG-PET
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 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.
Vascular inflammation is a key factor in both the pathogenesis and outcome of atherosclerosis.Resistin was shown to induce vascular endothelial dysfunction and vascular smooth muscle cell proliferation.
18F-fluorodeoxyglucose (FDG) positron emission tomography (PET) is a promising tool for identifying and quantifying vascular inflammation within atherosclerotic plaques.Therefore, the purpose of the study is to demonstrate the correlation between circulating resistin and vascular inflammation detected by 18FDG-PET in obese persons.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obese Group | – | Other: Cross sectional study |
| Non Obese Group | – | Other: Cross sectional study |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy participats who underwent a medical health check in the health promotion center in Korea Guro University
Key inclusion criteria (1 listed)
- Healthy 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 | Non Obese Group, Obese Group |
Primary outcome
Vascular inflammation in carotid arterial wall represented as the target-to-background ratio (TBR) using FDG-PET
Time frame: 12 weeks
3 secondary outcomes
Circulating serum adiponectin levels
Time frame: 12 weeks
carotid intima-media thickness levels measured using ultrasonography
Time frame: 12 weeks
Circulating serum resistin levels
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 8 Jul 2010.
Related trials for Atherosclerosis
Recruiting
Intracoronary Cryotherapy Effect on Stabilization of Vulnerable Plaque in Patients With Stable Angina or ACS - A Traditional Feasibility Study
Coronary Arterial Disease (CAD), Plaque
Recruiting
Personalised Multicomponent Exercise Programme in Peripheral Arterial Disease
Peripheral Arterial Disease, Intermittent Claudication
Recruiting
Isometric Resistance Exercise on Accelerated Atherosclerosis in Hypertension
Atherosclerosis Cardiovascular Disease
Active, not recruitingPhase 3
Evaluating the Impact of Maridebart Cafraglutide on Cardiovascular Outcomes in Participants With Atherosclerotic Cardiovascular Disease and Overweight or Obesity
Atherosclerotic Cardiovascular Disease, Overweight
Active, not recruitingObservational study
A Retrospective Cohort Study Evaluating Major Adverse Cardiovascular Events and Cardiovascular Outcomes in Adults With Atherosclerotic Cardiovascular Disease Without Prior Ischemic Events (OPTIMUS RISK - Spain)
Atherosclerotic Cardiovascular Disease
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 8 Jul 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 8 Jul 2010.