AtherosclerosisNCT01100671
Comparison of 18F-fluorodeoxyglucose Positron Emission Tomography and Coronary Computed Tomography in Assessing Vascular Inflammation
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. 18F-fluorodeoxyglucose (FDG) positron emission tomography (PET) is a promising tool for identifying and quantifying vascular inflammation within atherosclerotic plaques.cardiac multidetector-row CT can provide measurements… 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 section study
- How many people
- 120 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2010to Aug 2011
- 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 participants who underwent a medical health check in the health promotion center in Korea Guro University
Who may be able to join
- Healthy patients for visiting routine medical check in our clinic
Who cannot join
- History of cardiovascular disease (myocardial infarction, unstable angina, stroke, or cardiovascular revascularization)
- Diabetes
- Stage 2 hypertension (resting blood pressure, ≥ 160/100 mmHg)
- 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: Comparison of 18F-fluorodeoxyglucose Positron Emission Tomography and Coronary Computed Tomography in Assessing Vascular Inflammation in Healthy Population
Vascular inflammation is a key factor in both the pathogenesis and outcome of atherosclerosis. 18F-fluorodeoxyglucose (FDG) positron emission tomography (PET) is a promising tool for identifying and quantifying vascular inflammation within atherosclerotic plaques.cardiac multidetector-row CT can provide measurements of coronary artery calcium (CAC), the degree of stenosis, and the characteristics of plaque including its potential vulnerability. Therefore, the purpose of the investigators study is to compare the usefulness of 18 FDG-PET and MDCT in assessing the vascular inflammatory status and vulnerability.
- Conditions
- Atherosclerosis
- Being tested
- Cross section study
- Keywords
- atherosclerosis, vascular inflammation, MDCT, 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 section studyOther
This is not intervention study. The purpose of the study is to examine the relationship of vascular inflammation assessed by 18FDG-PET and MDCT at the cross section setting
| Study group | Role | What they receive |
|---|---|---|
| Healthy patients | Not described Receives: Other: Cross section study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between vascular inflammatory status measured by 18FDG PET and MDCT
Measured: 20weeks
Secondary outcomes (1)
Comparison the correlation with inflammatory marker and vascular inflammatory status assessed by 18FDG PET and MDCT
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionJul 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Cross-sectional
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kyung Mook Choi, Korea University
- Investigators
- Kyung Mook Choi, MD.PhD, Principal investigator, Korea University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01100671
- Sponsor's protocol ID
- PET_Coronary CT
- Status last verified
- Mar 2018
- First submitted
- 8 Apr 2010
- Last updated
- 14 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Yoo HJ, Yong HS, Hwang SY, Eo JS, Hong HC, Seo JA, Kim SG, Kim NH, Choi DS, Baik SH, Choi KM. Association of pooled cohort risk scores with vascular inflammation and coronary artery calcification in Korean adults. Metabolism. 2016 Mar;65(3):1-7. doi: 10.1016/j.metabol.2015.10.016. Epub 2015 Oct 22.
PubMed 26892510
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of 18F-fluorodeoxyglucose Positron Emission Tomography and Coronary Computed Tomography in Assessing Vascular Inflammation in Healthy Population
- ClinicalTrials.gov ID
- NCT01100671
- Acronym / sponsor ID
- PET_Coronary CT
- Conditions
- Atherosclerosis
- Keywords
- atherosclerosis, vascular inflammation, MDCT, 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
- Jul 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 9 Apr 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. 18F-fluorodeoxyglucose (FDG) positron emission tomography (PET) is a promising tool for identifying and quantifying vascular inflammation within atherosclerotic plaques.cardiac multidetector-row CT can provide measurements of coronary artery calcium (CAC), the degree of stenosis, and the characteristics of plaque including its potential vulnerability. Therefore, the purpose of the investigators study is to compare the usefulness of 18 FDG-PET and MDCT in assessing the vascular inflammatory status and vulnerability.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy patients | – | Other: Cross section study |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy participants who underwent a medical health check in the health promotion center in Korea Guro University
Key inclusion criteria (1 listed)
- Healthy patients 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
- Stage 2 hypertension (resting blood pressure, ≥ 160/100 mmHg)
- 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 section studyThis is not intervention study. The purpose of the study is to examine the relationship of vascular inflammation assessed by 18FDG-PET and MDCT at the cross section setting | Other | Healthy patients |
Primary outcome
Correlation between vascular inflammatory status measured by 18FDG PET and MDCT
Time frame: 20weeks
1 secondary outcome
Comparison the correlation with inflammatory marker and vascular inflammatory status assessed by 18FDG PET and MDCT
Time frame: 20 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 14 Mar 2018.
- Derived from this study: PubMed 26892510Yoo HJ, Yong HS, Hwang SY, Eo JS, Hong HC, Seo JA, Kim SG, Kim NH, Choi DS, Baik SH, Choi KM. Association of pooled cohort risk scores with vascular inflammation and coronary artery calcification in Korean adults. Metabolism. 2016 Mar;65(3):1-7. doi: 10.1016/j.metabol.2015.10.016. Epub 2015 Oct 22.
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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 14 Mar 2018. 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?
Correlation between vascular inflammatory status measured by 18FDG PET and MDCT (time frame: 20weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01100671, which also lists 1 linked publication.
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 Mar 2018.