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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00819273
First received: January 7, 2009
Last updated: December 2, 2010
Last verified: December 2010
  Purpose

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.


Condition
hsCRP

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Investigation Into the CorrelAtion of pLasma Hs-CRP Concentrations and cardiovascuLar rISk in Korean populaTiOn

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 1700
Study Start Date: March 2009
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
patients who have records of clinic visit with circulatory and endocrine internal medicines of nationwide tertiary hospitals within the last one year.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00819273

Locations
Korea, Republic of
Research Site
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
Wonju-si, Kangwon-do, Korea, Republic of
Research Site
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
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Baek Sanghong, Ph.D. The Catholic University
  More Information

No publications provided

Responsible Party: Hyunah Caroline, Choi / CV TA Physician, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00819273     History of Changes
Other Study ID Numbers: NIS-CKR-DUM-2008/5
Study First Received: January 7, 2009
Last Updated: December 2, 2010
Health Authority: Korea: Food and Drug Administration

Keywords provided by AstraZeneca:
hsCRP

ClinicalTrials.gov processed this record on April 21, 2014