Cardiovascular RiskNCT01139827
Association Between Framingham Risk Score, hsCRP and Vascular Inflammation: Analysis With 18F-Fluorodeoxyglucose Positron Emission Tomography
An observational study of Cardiovascular Risk, run by Korea University Guro Hospital at 1 site in South Korea.
Trial summary
Framingham risk score is well known screening tool that detect cardiovascular (CV) risk. But it is not suitable for CV risk in mild risk group. So 18F-fluorodeoxyglucose positron emission tomography (FDG-PET) is a new imaging technique for detecting vascular inflammation within atherosclerotic plaques and hsCRP is… Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Cardiovascular Risk
- How many people
- 178 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2009to Feb 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 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The subjects underwent routine health checkups at Korea University Guro Hospital. Patients with DM or gestational diabetes were not included.
Who may be able to join
- healthy subjects
Who cannot join
- a history of cardiovascular disease (myocardial infarction, unstable angina, stroke or cardiovascular revascularization)
- active inflammatory disease, recent active infection
- stage 2 hypertension (resting blood pressure, ≥ 160/100 mmHg)
- diabetes mellitus
- systemic disorders such as severe hepatic, renal, and hematologic diseases
- taking drugs known to interfere with vascular inflammation measured by FDG-PET.
Trial locations and contacts
1 site in 1 country.
About this study
Framingham risk score is well known screening tool that detect cardiovascular (CV) risk. But it is not suitable for CV risk in mild risk group. So 18F-fluorodeoxyglucose positron emission tomography (FDG-PET) is a new imaging technique for detecting vascular inflammation within atherosclerotic plaques and hsCRP is also arising detection tool of CV risk.
The investigators are examining this association in normal and impaired glucose tolerance patients groups.
Read the detailed description
We examined vascular inflammation using FDG-PET scan in 178 subjects (Normal and impaired glucose tolerance groups). Vascular 18F-FDG uptake was measured as both the mean and maximum blood-normalized standardized uptake value (SUV), known as the target-to-background ratio (TBR). And We analyzed that the association with Framingham risk score, hs CRP and vascular inflammation by FDG-PET scan.
- Conditions
- Cardiovascular Risk
- Keywords
- atherosclerosis, inflammation, hsCRP, Framingham risk score, positron emission tomography, inflammation in FDG-PET
- Medical subject headings
- Atherosclerosis, Inflammation
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 |
|---|---|---|
| normal | normal group has no diabetes. | |
| IGT | IGT group has impaired fasting glucose or impaired glucose tolerance. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2010 (estimated)
- Study startSep 2009
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular RiskStudies 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
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea University Guro Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01139827
- Sponsor's protocol ID
- PET(FRS-CRP)
- Status last verified
- Feb 2010
- First submitted
- 8 Jun 2010
- Last updated
- 9 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Framingham Risk Score, hsCRP and Vascular Inflammation: Analysis With 18F-Fluorodeoxyglucose Positron Emission Tomography
- ClinicalTrials.gov ID
- NCT01139827
- Acronym / sponsor ID
- PET(FRS-CRP)
- Conditions
- Cardiovascular Risk
- Keywords
- atherosclerosis, inflammation, hsCRP, Framingham risk score, positron emission tomography, inflammation in FDG-PET
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Korea University Guro HospitalUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 9 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.
Framingham risk score is well known screening tool that detect cardiovascular (CV) risk. But it is not suitable for CV risk in mild risk group. So 18F-fluorodeoxyglucose positron emission tomography (FDG-PET) is a new imaging technique for detecting vascular inflammation within atherosclerotic plaques and hsCRP is also arising detection tool of CV risk.
The investigators are examining this association in normal and impaired glucose tolerance patients groups.
Detailed description
We examined vascular inflammation using FDG-PET scan in 178 subjects (Normal and impaired glucose tolerance groups). Vascular 18F-FDG uptake was measured as both the mean and maximum blood-normalized standardized uptake value (SUV), known as the target-to-background ratio (TBR). And We analyzed that the association with Framingham risk score, hs CRP and vascular inflammation by FDG-PET scan.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| normal | – | –normal group has no diabetes. |
| IGT | – | –IGT group has impaired fasting glucose or impaired glucose tolerance. |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The subjects underwent routine health checkups at Korea University Guro Hospital. Patients with DM or gestational diabetes were not included.
Key inclusion criteria (1 listed)
- healthy subjects
Key exclusion criteria (6 listed)
- a history of cardiovascular disease (myocardial infarction, unstable angina, stroke or cardiovascular revascularization)
- active inflammatory disease, recent active infection
- stage 2 hypertension (resting blood pressure, ≥ 160/100 mmHg)
- diabetes mellitus
- systemic disorders such as severe hepatic, renal, and hematologic diseases
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
Not reported in the source record.
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 9 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.
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 Cardiovascular Risk, run by Korea University Guro Hospital 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 9 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.
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 9 Jun 2010.