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

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.

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Key information

Conditions

Chest Pain Angina Pectoris Arterial Occlusive Diseases Arteriosclerosis CAD CHD CVD Cardiovascular Diseases Coronary Artery Disease Coronary Disease Coronary Heart Disease Heart Diseases Myocardial Ischemia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Warner Family Practice, Chandler, Arizona, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Corus CAD (ASGES)

Diagnostic Test

Age/Sex/Gene Expression Score - ASGES

Primary outcomes

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

Time frame: 1 month

Secondary outcomes

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.

Time frame: 12 months

Sponsors and collaborators

Lead sponsor

CardioDx

Industry

Registry information

Official study title

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

Acronym: PRESET

Important dates

Study start: 2012
Primary completion: 2014
Study completion: 2015
First posted: Aug 31, 2012
Registry last updated: Jan 31, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed