Investigation Into the Correlation of Plasma Hs-CRP Concentrations and Cardiovascular Risk in Korean Population (CALLISTO)
This study has been completed.
Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00819273
First received: January 7, 2009
Last updated: December 2, 2010
Last verified: December 2010
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | January 7, 2009 | ||||
| Last Updated Date | December 2, 2010 | ||||
| Start Date ICMJE | March 2009 | ||||
| Primary Completion Date | August 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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. ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00819273 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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. ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Investigation Into the Correlation of Plasma Hs-CRP Concentrations and Cardiovascular Risk in Korean Population | ||||
| Official Title ICMJE | Investigation Into the CorrelAtion of pLasma Hs-CRP Concentrations and cardiovascuLar rISk in Korean populaTiOn | ||||
| Brief 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Patients who have records of clinic visit with circulatory and endocrine internal medicines of nationwide tertiary hospitals within the last one year. |
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| Condition ICMJE | hsCRP | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | 1
patients who have records of clinic visit with circulatory and endocrine internal medicines of nationwide tertiary hospitals within the last one year. |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 1700 | ||||
| Completion Date | August 2009 | ||||
| Primary Completion Date | August 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Korea, Republic of | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00819273 | ||||
| Other Study ID Numbers ICMJE | NIS-CKR-DUM-2008/5 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Hyunah Caroline, Choi / CV TA Physician, AstraZeneca Pharmaceuticals | ||||
| Study Sponsor ICMJE | AstraZeneca | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | AstraZeneca | ||||
| Verification Date | December 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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