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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2009-08-31

Study Completion Date

2009-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Project 3: ACHIEVE- CHD

NCT05918380

Coronary Heart Disease

RECRUITING NA

Coronary Obstruction Detection by Molecular Personalized Gene Expression (Corus CAD or ASGES)

NCT01117506

Coronary Artery Disease Chest Pain Cardiovascular Diseases +5 more

COMPLETED

Coronary Artery Calcium, Exercise Tests, and CHD Outcome

NCT00005562

Cardiovascular Diseases Coronary Disease Cerebrovascular Disorders +2 more

COMPLETED

Inflammation as a Predictor in Cardioversion of Atrial Fibrillation

NCT00590525

Atrial Fibrillation

COMPLETED

Using Differences in Peripheral Blood Leukocyte Gene Expression to Determine Cardiovascular Disease Risk

NCT00613158

Atherosclerosis Cardiovascular Diseases

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cardiovascular Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No