Clinical Performance Evaluation of the Cholestech LDX Cardiac hsCRP Test (CLEAR)

Withdrawn before enrolling

Conditions studied: Cardiovascular Disease

In brief

This is a multi-center study designed to assess the accuracy and precision of the Cholestech LDX Cardiac hsCRP test for the quantitative determination of C-reactive protein (CRP) in whole blood, serum and plasma from individuals being assessed for risk of cardiovascular disease. The Cholestech LDX Cardiac hsCRP test consists of the CRP cassette and LDX analyzer and measures CRP with high sensitivity on fingerstick or venous whole blood at the point-of-care (POC). The results of this study are intended to be used for regulatory 510k filings for use as an in vitro diagnostic test.

Key facts

Study ID

NCT00933764

Run by

Abbott RDx Cardiometabolic

People needed

0

Starts

2009-08-01

Expected to finish

2009-11-01

Last updated by the study team

2015-07-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults (18 years of age or older) presenting to their physician's office or outpatient clinic for routine or pre-scheduled visits and a candidate for cardiovascular risk assessment.
• Willing and able to provide written informed consent and comply with study procedures.

You may not qualify if…

• Known hematocrit <30% or > 52%;
• History of medical conditions - other than risk of cardiovascular disease - that may elevate CRP as listed in Appendix B (e.g., tissue damage, infection, inflammation, malignant neoplasia)
• Vulnerable populations deemed inappropriate for study by the site's principal investigator.

Where it is running

• St. Joseph's Research Institute — Atlanta, Georgia, United States
• Heart and Vascular Research Center of Northern Michigan — Petoskey, Michigan, United States

Full record on ClinicalTrials.gov

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