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



Status:Completed
Conditions:Angina, Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:21 - Any
Updated:2/2/2019
Start Date:April 2012
End Date:May 2013

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Enhanced Assessment of Chest Pain and Related Symptoms in the Primary Care Setting Through the Use of a Novel Personalized Medicine Genomic Test: Results From a Prospective Registry Study.

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.

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.

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
We found this trial at
7
sites
Gilbert, Arizona 85296
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Maringouin, Louisiana 70757
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Tempe, Arizona 85283
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Tempe, AZ
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Wake Forest, North Carolina 27587
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Wake Forest, NC
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Woodstock, Georgia 30189
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Woodstock, GA
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Youngstown, Ohio 44505
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Youngstown, OH
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Zachary, Louisiana 70791
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Zachary, LA
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