NCT00819273

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,700

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2009

Shorter than P25 for all trials

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 7, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 8, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

December 6, 2010

Status Verified

December 1, 2010

Enrollment Period

5 months

First QC Date

January 7, 2009

Last Update Submit

December 2, 2010

Conditions

Keywords

hsCRP

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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.

Study Arms (1)

1

patients who have records of clinic visit with circulatory and endocrine internal medicines of nationwide tertiary hospitals within the last one year.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Research Site

Wŏnju, Gangwon-do, South Korea

Location

Research Site

Anyang-si, Gyeonggi-do, South Korea

Location

Research Site

Goyang-si, Gyeonggi-do, South Korea

Location

Research Site

Uijeongbu-si, Gyeonggi-do, South Korea

Location

Research Site

Busan, South Korea

Location

Research Site

Daegu, South Korea

Location

Research Site

Daejeon, South Korea

Location

Research Site

Jeonju, South Korea

Location

Research Site

Kwangju-si, South Korea

Location

Research Site

Seoul, South Korea

Location

Study Officials

  • Baek Sanghong, Ph.D.

    The Catholic University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 7, 2009

First Posted

January 8, 2009

Study Start

March 1, 2009

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

December 6, 2010

Record last verified: 2010-12

Locations