Investigation Into the Correlation of Plasma Hs-CRP Concentrations and Cardiovascular Risk in Korean Population (CALLISTO)

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.

Study Overview

• Status: Completed
• Conditions: hsCRP

• Study Type: Observational
• Enrollment (Anticipated): 1700

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan-si, Korea, Republic of
    • Research Site
  • Daegu-si, Korea, Republic of
    • Research Site
  • Daejeon-si, Korea, Republic of
    • Research Site
  • Jeonju-si, Korea, Republic of
    • Research Site
  • Kwangju-si, Korea, Republic of
    • Research Site
  • Seoul, Korea, Republic of
    • Research Site
  • Gyeonggi-do
    • Anyang-si, Gyeonggi-do, Korea, Republic of
      • Research Site
    • Goyang-si, Gyeonggi-do, Korea, Republic of
      • Research Site
    • Uijeongbu-si, Gyeonggi-do, Korea, Republic of
      • Research Site
  • Kangwon-do
    • Wonju-si, Kangwon-do, Korea, Republic of
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evaluate hs-CRP levels according to risk categories by the NCEP ATP III.	Within the last 12 months from the date of data entry.

Secondary Outcome Measures

Outcome Measure	Time Frame
Evaluate a relationship between hs-CRP and each CHD CVD risk factor including LDL-C.	Within the last 12 months from the date of data entry.

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: Baek Sanghong, Ph.D., The Catholic University

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): August 1, 2009
• Study Completion (Actual): August 1, 2009

Study Registration Dates

• First Submitted: January 7, 2009
• First Submitted That Met QC Criteria: January 7, 2009
• First Posted (Estimate): January 8, 2009

Study Record Updates

• Last Update Posted (Estimate): December 6, 2010
• Last Update Submitted That Met QC Criteria: December 2, 2010
• Last Verified: December 1, 2010

More Information

Terms related to this study

• Keywords: hsCRP
• Other Study ID Numbers: NIS-CKR-DUM-2008/5