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

Abbott RDx Cardiometabolic

Status: Withdrawn

Conditions: Cardiovascular Disease

Study type: Observational

Funder types: Other

Identifiers

NCT00933764

BSTE-0113

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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.
2. Willing and able to provide written informed consent and comply with study procedures.

Exclusion criteria

1. Known hematocrit <30% or > 52%;
2. 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)
3. Vulnerable populations deemed inappropriate for study by the site's principal investigator.