Investigation of a Novel Gene Expression Test (ASGES or Corus CAD) for Diagnosis of Obstructive Coronary Artery Disease

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

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Recruitment Status

COMPLETED

Total Enrollment

342 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-04-30

Study Completion Date

2013-05-31

Brief Summary

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The objective of this study is to collect data on the commercial use of Corus CAD (Age/Sex/Gene Expression score - ASGES) blood test to evaluate the clinical referral patterns of Primary Care Physicians after receipt of their patients' Corus Score, and to better understand patient management patterns for clinicians ordering the test.

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Detailed Description

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This is a prospective, multicenter observational registry collecting and analyzing commercial utilization data of the Corus CAD assay ("Test") also known as Age/Sex/Gene Expression score (ASGES) . The study will prospectively enroll approximately 670 evaluable subjects from qualified sites and evaluate the rate of referral versus Corus CAD (ASGES) score as continuous variables.

Objective of the study is to assess whether the score provided by the Corus CAD (Age/Sex/Gene Expression score - ASGES) test has an effect on the Primary Care Physician's patient management and referral patterns once received:

1. No further cardiac testing or treatment
2. Medical therapy for angina or non-cardiac chest pain
3. Referral to a cardiologist for stress testing with or without imaging, CT angiography, or invasive cardiac catheterization.

Since it takes approximately two days for the physician to receive the result of the Corus CAD (Age/Sex/Gene Expression score - ASGES) , initial diagnostic testing will reflect local standard of care.

Conditions

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Coronary Artery Disease Angina Pectoris Chest Pain Cardiovascular Diseases Coronary Heart Disease CAD CVD CHD

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Corus CAD (ASGES)

Age/Sex/Gene Expression Score - ASGES

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

1. Patients with symptoms suggestive of CAD, including typical or atypical angina or angina equivalent
2. The patient has signed the appropriate Institutional Review Board approved Informed Consent Form

Exclusion Criteria

1. History of myocardial infarction
2. Current MI or acute coronary syndrome
3. Current New York Heart Association (NYHA) class III or IV congestive heart failure symptoms
4. Any previous coronary Revascularization
5. Any individuals with:

* Diabetes
* Suspected unstable angina
* Systemic infections
* Systemic inflammatory conditions
6. Any individuals currently taking:

* Steroids
* Immunosuppressive agents
* Chemotherapeutic agents
7. Recipient of any organ transplant

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No