hsCRPCALLISTONCT00819273
Investigation Into the Correlation of Plasma Hs-CRP Concentrations and Cardiovascular Risk in Korean Population
An observational study of hsCRP, run by AstraZeneca at 10 sites in South Korea.
Trial summary
An observational, non-interventional, multi-centre study to provide further information on the utility of test for a predictive marker by investigating the current prevalence of high sensitivity CRP (hs-CRP) testing and characteristics of each CVD risk group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- hsCRP
- How many people
- 1,700 participants
- Where
- 10 sitesSouth Korea
- Study dates
- Mar 2009to Aug 2009
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have records of clinic visit with circulatory and endocrine internal medicines of nationwide tertiary hospitals within the last one year.
Who may be able to join
- Subjects with at least one clinic visit record within the last 12 months from the date of data entry.
- Subjects with at least one hs-CRP level measured within the last 12 months from the date of data entry.
Who cannot join
- Use of statins or other lipid-lowering therapies including fibrates, niacin, and bile acid sequestrants in the past 3 months prior to hsCRP measurement
- Active inflammatory diseases documented during the period of CRP measurement
- Subjects taking immunosuppressants
- Findings of chronic inflammation: arthritis, lupus, or inflammatory bowel disease
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
South Korea10 sites
Research Site
Anyang-si, Gyeonggi-do
Research Site
Busan
Research Site
Daegu
Research Site
Daejeon
Research Site
Goyang-si, Gyeonggi-do
Research Site
Jeonju
Research Site
Kwangju-si
Research Site
Seoul
Research Site
Uijeongbu-si, Gyeonggi-do
Research Site
Wŏnju, Gangwon-do
About this study
Official title: Investigation Into the CorrelAtion of pLasma Hs-CRP Concentrations and cardiovascuLar rISk in Korean populaTiOn
An observational, non-interventional, multi-centre study to provide further information on the utility of test for a predictive marker by investigating the current prevalence of high sensitivity CRP (hs-CRP) testing and characteristics of each CVD risk group.
- Conditions
- hsCRP
- Keywords
- hsCRP
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 |
|---|---|---|
| 1 | patients who have records of clinic visit with circulatory and endocrine internal medicines of nationwide tertiary hospitals within the last one year. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate hs-CRP levels according to risk categories by the NCEP ATP III.
Measured: Within the last 12 months from the date of data entry.
Secondary outcomes (1)
Evaluate a relationship between hs-CRP and each CHD CVD risk factor including LDL-C.
Measured: Within the last 12 months from the date of data entry.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2009 (estimated)
- Study startMar 2009
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for hsCRPStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 1,700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Baek Sanghong, Ph.D., Principal investigator, The Catholic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00819273
- Sponsor's protocol ID
- NIS-CKR-DUM-2008/5
- Acronym
- CALLISTO
- Status last verified
- Dec 2010
- First submitted
- 7 Jan 2009
- Last updated
- 6 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation Into the CorrelAtion of pLasma Hs-CRP Concentrations and cardiovascuLar rISk in Korean populaTiOn
- ClinicalTrials.gov ID
- NCT00819273
- Acronym / sponsor ID
- CALLISTO / NIS-CKR-DUM-2008/5
- Conditions
- hsCRP
- Keywords
- hsCRP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,700 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 8 Jan 2009 (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.
An observational, non-interventional, multi-centre study to provide further information on the utility of test for a predictive marker by investigating the current prevalence of high sensitivity CRP (hs-CRP) testing and characteristics of each CVD risk group.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –patients who have records of clinic visit with circulatory and endocrine internal medicines of nationwide tertiary hospitals within the last one year. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have records of clinic visit with circulatory and endocrine internal medicines of nationwide tertiary hospitals within the last one year.
Key inclusion criteria (2 listed)
- Subjects with at least one clinic visit record within the last 12 months from the date of data entry.
- Subjects with at least one hs-CRP level measured within the last 12 months from the date of data entry.
Key exclusion criteria (4 listed)
- Use of statins or other lipid-lowering therapies including fibrates, niacin, and bile acid sequestrants in the past 3 months prior to hsCRP measurement
- Active inflammatory diseases documented during the period of CRP measurement
- Subjects taking immunosuppressants
- Findings of chronic inflammation: arthritis, lupus, or inflammatory bowel 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
Evaluate hs-CRP levels according to risk categories by the NCEP ATP III.
Time frame: Within the last 12 months from the date of data entry.
1 secondary outcome
Evaluate a relationship between hs-CRP and each CHD CVD risk factor including LDL-C.
Time frame: Within the last 12 months from the date of data entry.
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 6 Dec 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.
Baek Sanghong, Ph.D. principal investigator
The Catholic University
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of hsCRP, run by AstraZeneca at 10 sites 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 6 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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?
Evaluate hs-CRP levels according to risk categories by the NCEP ATP III. (time frame: Within the last 12 months from the date of data entry.). 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 6 Dec 2010.