A Registry to Evaluate Patterns of Care Associated With the Use of Corus CAD (or ASGES) in Primary Care Settings

Study Overview
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Brief Summary
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The PRESET Registry--A Registry to Evaluate Patterns of Care Associated With the Use of Corus CAD (Age/Sex/Gene Expression score - ASGES) in Real World Clinical Care Settings (PRESET)--was designed as an observational, post-market, real-world registry to evaluate patterns of care, including referrals to a cardiologist, cardiac stress testing, CT angiography, within the first month after Corus CAD (ASGES) testing.

Detailed Description
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The prospective PRESET Registry (NCT01677156) enrolled stable, nonacute adult patients presenting with typical or atypical symptoms suggestive of obstructive coronary artery disease from 21 US primary care practices from August 2012 to August 2014. Demographics, clinical characteristics, and Corus CAD (Age/Sex/Gene Expression score - ASGES) results (predefined as low [ASGES <15] or elevated [ASGES >15]) were collected, as were referrals to Cardiology or further functional/anatomic cardiac testing after Corus CAD (Age/Sex/Gene Expression score - ASGES) testing. Patients were followed for 1 year post ASGES testing.

Official Title
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The PRESET Registry: A Registry to Evaluate Patterns of Care Associated With the Use of Corus CAD (Age/Sex/Gene Expression Score - ASGES) in Real World Clinical Care Settings

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

Intervention / Treatment
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* Diagnostic Test: CORUS CAD (ASGES)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Symptoms suggestive of CAD, according to the opinion of the site registry clinician Receiving Corus CAD (ASGES) to aid in the diagnosis of obstructive CAD Age >= 18 years Willing and able to provide written informed consent Exclusion Criteria: History of myocardial infarction (MI) Current MI or acute coronary syndrome Current New York Heart Association (NYHA) class III or IV congestive heart failure symptoms Known/documented CAD Diabetes Mellitus

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Receiving Corus CAD (ASGES)<br>Patients receiving Corus CAD (ASGES) to aid in the diagnosis of obstructive CAD | Diagnostic Test: CORUS CAD (ASGES)<br>* Age/Sex/Gene Expression Score - ASGES<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To describe referral patterns for cardiac care and testing within 1 month after gene expression testing. |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To describe follow up events (eg., diagnoses, non-cardiac testing, medication use, MACE) at 12 months follow up within ASGES (age, sex,gene expression score) test strata. |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ASGES, Corus CAD, Age/Sex/Gene Expression Score, Gene Expression, GES, CAD, CVD, CHD, Precision Medicine, Clinical Utility, Registry, Coronary Artery Disease, Angina Pectoris, Chest Pain, Cardiovascular Disease, Coronary Heart Disease, PRESET