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

Conditions

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

Keywords

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

Brief summary

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

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.

Burcu Gül, Alexandra J. Lansky, Matthew J. Budoff, David Sharp, Bruce Maniet et al. (10 authors)

Journal of Women s Health2019-01-172 citations

10.1089/jwh.2018.7203

Utility of a Precision Medicine Test in Elderly Adults with Symptoms Suggestive of Coronary Artery Disease.

Ladapo JA, Budoff MJ, Sharp D, Kuo JZ, Huang L, Maniet B, Herman L, Monane M.

2017-12-063 citations

10.1111/jgs.15215

Abstract 070: A Precision Medicine Test Influenced Costs of Care Among Patients Presenting With Stable Symptoms Suggestive of Obstructive Coronary Artery Disease: Economic Endpoint Analysis From the PRESET Registry

Joseph A. Ladapo, Matthew J. Budoff, David Sharp, Pejman Azarmina, Lin Huang et al. (8 authors)

Circulation Cardiovascular Quality and Outcomes2017-03-01

10.1161/circoutcomes.10.suppl_3.070

Clinical Utility of a Precision Medicine Test Evaluating Outpatients with Suspected Obstructive Coronary Artery Disease.

Ladapo JA, Budoff M, Sharp D, Zapien M, Huang L, Maniet B, Herman L, Monane M.

2016-12-169 citations

10.1016/j.amjmed.2016.11.021

Abstract 142: Primary Endpoint Results from a Community-Based Registry Evaluating the Use of a Blood-Based Age/Sex/Gene Expression Test in Patients Presenting with Symptoms Suggestive of Obstructive Coronary Artery Disease: the PRESET Registry (A Registry to Evaluate Patterns of Care Associated with the Use of Corus® CAD in Real World Clinical Care Settings)

Joseph A. Ladapo, Matthew J. Budoff, Linda Ross, Lin Huang, David Sharp et al. (9 authors)

Circulation Cardiovascular Quality and Outcomes2015-05-011 citations

10.1161/circoutcomes.8.suppl_2.142

Abstract 167: The Use of a Personalized Medicine, Blood-based Gene Expression Score in a Community-Based Cardiovascular Registry Enrolling Patients Presenting with Symptoms Suggestive of Obstructive Coronary Artery Disease: Interim Results from the PRESET (A Registry to Evaluate Patterns of Care Associated with the Use of Corus® CAD in Real World Clinical Care Settings) Registry.

Joseph A. Ladapo, David Sharp, Bruce Maniet, Linda Ross, John Blanchard et al. (7 authors)

Circulation Cardiovascular Quality and Outcomes2014-07-01

10.1161/circoutcomes.7.suppl_1.167

Interventions

DIAGNOSTIC_TESTCORUS CAD (ASGES)

Age/Sex/Gene Expression Score - ASGES

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

1. Symptoms suggestive of CAD, according to the opinion of the site registry clinician 2. Receiving Corus CAD (ASGES) to aid in the diagnosis of obstructive CAD 3. Age \>= 18 years 4. Willing and able to provide written informed consent

Exclusion criteria

1. History of myocardial infarction (MI) 2. Current MI or acute coronary syndrome 3. Current New York Heart Association (NYHA) class III or IV congestive heart failure symptoms 4. Known/documented CAD 5. Diabetes Mellitus

Design outcomes

Primary

Measure	Time frame
To describe referral patterns for cardiac care and testing within 1 month after gene expression testing.	1 month

Secondary

Measure	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

Countries

United States

Outcome results

None listed