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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 16, 2014