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

hsCRP Clinical Trial

— CALLISTO  

Official title:

Investigation Into the CorrelAtion of pLasma Hs-CRP Concentrations and cardiovascuLar rISk in Korean populaTiOn

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00819273
• Other study ID #: NIS-CKR-DUM-2008/5
• Status: Completed
• Phase: N/A
• First received: January 7, 2009
• Last updated: December 2, 2010
• Start date: March 2009
• Est. completion date: August 2009

Study information

• Verified date: December 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1700
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• hsCRP

Locations

Country	Name	City	State
Korea, Republic of	Research Site	Anyang-si	Gyeonggi-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	Goyang-si	Gyeonggi-do
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	Uijeongbu-si	Gyeonggi-do
Korea, Republic of	Research Site	Wonju-si	Kangwon-do

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate hs-CRP levels according to risk categories by the NCEP ATP III.		Within the last 12 months from the date of data entry.	No
Secondary	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.	No