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

This study has been withdrawn prior to enrollment.
Information provided by:
Biosite Identifier:
First received: July 3, 2009
Last updated: July 20, 2015
Last verified: July 2015
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.

Cardiovascular Disease

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective

Further study details as provided by Biosite:

Biospecimen Retention:   Samples Without DNA
Plasma and Serum samples will be retained for reference testing and banking.

Enrollment: 0
Study Start Date: August 2009
Estimated Study Completion Date: November 2009
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Individuals being assessed of their risk of cardiovascular disease. Patients can currently be diagnosed with cardiovascular disease.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00933764

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

Responsible Party: Meghan Bigelow / Clinical Trial Manager, Inverness Medical Innovations Identifier: NCT00933764     History of Changes
Other Study ID Numbers: BSTE-0113
Study First Received: July 3, 2009
Last Updated: July 20, 2015

Additional relevant MeSH terms:
Cardiovascular Diseases processed this record on September 21, 2017