Investigation Into the Correlation of Plasma hs-CRP Concentrations and Cardiovascular Risk in Korean Population - Full Text View

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

This study is not yet open for participant recruitment.

Verified by AstraZeneca, January 2009

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00819273

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

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, 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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	1700
Study Start Date:	January 2009
Estimated Study Completion Date:	June 2009

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

Contacts

Contact: AstraZeneca Clinical Study Information

+82-2188-0800

Locations

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

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:

Baek Sanghong, Ph.D.

The Catholic University

More Information

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

Keywords provided by AstraZeneca:

hsCRP

ClinicalTrials.gov processed this record on January 16, 2009