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

NCT00933764 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2015-07-21

No results posted yet for this study

Summary

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.

Conditions

Sponsors & Collaborators

  • Abbott RDx Cardiometabolic

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2009-10-31
Completion
2009-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00933764 on ClinicalTrials.gov