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

CardioDx

Status: Completed

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

Treatments: Diagnostic Test: CORUS CAD (ASGES)

Study type: Observational

Funder types: Industry

Identifiers

NCT01677156

PRESET (Other Identifier)

CDX_000015

Details and patient eligibility

About

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.

Full 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.

Enrollment: 713 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

713 participants in 1 patient group

Receiving Corus CAD (ASGES)

Description:

Patients receiving Corus CAD (ASGES) to aid in the diagnosis of obstructive CAD

Treatment:

Diagnostic Test: CORUS CAD (ASGES)