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

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.

Study Overview

• Status: Withdrawn
• Conditions: Cardiovascular Disease

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • St. Joseph's Research Institute
  • Michigan
    • Petoskey, Michigan, United States, 49770
      • Heart and Vascular Research Center of Northern Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Individuals being assessed of their risk of cardiovascular disease. Patients can currently be diagnosed with cardiovascular disease.

Description

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.

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: Biosite

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Anticipated): October 1, 2009
• Study Completion (Anticipated): November 1, 2009

Study Registration Dates

• First Submitted: July 3, 2009
• First Submitted That Met QC Criteria: July 6, 2009
• First Posted (Estimate): July 7, 2009

Study Record Updates

• Last Update Posted (Estimate): July 21, 2015
• Last Update Submitted That Met QC Criteria: July 20, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: BSTE-0113