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

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ClinicalTrials.gov Identifier: NCT00933764
Recruitment Status : Withdrawn
First Posted : July 7, 2009
Last Update Posted : July 21, 2015
Sponsor:
Information provided by:
Biosite

Study Description
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Brief 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.

Condition or disease
Cardiovascular Disease

Study Design
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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Only
Time Perspective: Prospective
Study Start Date : August 2009
Estimated Primary Completion Date : October 2009
Estimated Study Completion Date : November 2009
Groups and Cohorts
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Outcome Measures
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Biospecimen Retention:   Samples Without DNA
Plasma and Serum samples will be retained for reference testing and banking.

Eligibility Criteria
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Information from the National Library of Medicine

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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.
Criteria

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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00933764


Locations
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
Biosite
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Meghan Bigelow / Clinical Trial Manager, Inverness Medical Innovations
ClinicalTrials.gov Identifier: NCT00933764     History of Changes
Other Study ID Numbers: BSTE-0113
First Posted: July 7, 2009    Key Record Dates
Last Update Posted: July 21, 2015
Last Verified: July 2015

Additional relevant MeSH terms:
Cardiovascular Diseases