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Completed

NCT Number: NCT01594411

PCP Use of a Gene Expression Test (Corus CAD or ASGES) in Coronary Artery Disease Diagnosis

This is a prospective, multi-center study examining the clinical impact of the Corus CAD (Age/Sex/Gene Expression score - ASGES) assay in approximately 250 evaluable subjects with no history of obstructive coronary artery disease who now present with chest pain or anginal-equivalent symptoms to a primary care physician (PCP) for evaluation.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

John's Creek Primary Care, Suwanee, Georgia, United States

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About this study

In symptomatic patients with or without prior cardiac testing, the PCP will initially decide the subject's pretest probability for coronary artery disease (CAD) based on the subject's risk factors and quality of chest pain (typical or atypical), or anginal equivalent (e.g., jaw, arm pain, or unexplained shortness of breath) and consider the results of prior testing, if applicable. The initial questionnaire will capture the PCP's initial clinical impression and decision ('preliminary decision') on how to further evaluate and manage the patient. A Corus CAD (Age/Sex/Gene Expression score - ASGES) assay will be performed at the PCP's office. After the PCP has received the Corus CAD (ASGES) result (approximately 2-3 days later), the PCP will decide on the appropriate evaluation and management of the patient ('final decision') using the Corus CAD (ASGES) result in conjunction with his/her clinical impression and/or other clinical data available. The primary aim of this study is to evaluate whether the Corus CAD (ASGES) test results is associated with a change in the PCPs' diagnostic evaluation and management of patients as compared to their initial testing and treatment decisions.

Since it takes approximately two days for the physician to receive the result of the Corus CAD (ASGES), symptomatic subjects with unstable angina, or suspicion for myocardial infarction will be excluded from the study.

A follow-up phone call and a detailed questionnaire will be performed at 30 + 15 days, from the time of blood draw, to assess the triage decision, such as referral to any subspecialists (cardiologist, gastroenterologist, and pulmonologist), cardiac diagnostic tests performed, cardiac procedures performed, and results of these cardiac tests and procedures.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Stable chest pain, typical or atypical angina or anginal equivalent
  • The patient has signed the appropriate Institutional Review Board approved Informed Consent Form.

Exclusion criteria

  • History of myocardial infarction
  • Current Myocardial infarction (MI) or acute coronary syndrome.
  • Current New York Heart Association (NYHA) class III or IV congestive heart failure symptoms.
  • Any previous coronary revascularization.
  • Any individuals with :
  • Diabetes
  • Suspected unstable angina
  • Systemic infections
  • Systemic inflammatory conditions
  • Any individuals currently taking:
  • Steroids
  • Immunosuppressive agents
  • Chemotherapeutic agents
  • Any Major Surgery within 2 months

Treatment and study plan

Corus CAD

Diagnostic Test

Age/Sex/Gene Expression Score (ASGES)

Primary outcomes

  1. Change in Clinicians' Treatment Decision After Age/Sex/Gene Expression Score

    Time frame: pre- and post- gene expression testing results (on average 2-3 days to receive ASGES)

    The primary objective was to assess whether the Age/Sex/Gene Expression Score (ASGES) altered clinicians' evaluations, defined by a change in patient management from preliminary to final decision. The change was prospectively defined as a downgrade or upgrade in intensity of the diagnostic plan based on the following hierarchical categories:(1) no further cardiac testing or treatment, (2) lifestyle changes or medical therapy, (3) stress testing (with or without imaging) or computed tomography/coronary angiography, or (4) invasive coronary angiography. The ASGES algorithm comprises expression values for 23 genes from peripheral blood cells in 6 terms, patient age, and sex. The changes in gene expression are quantified using an algorithm that generates a ASGES ranging from 1 to 40. A score <=15 indicates a low risk of underlying obstructive coronary disease. The ASGES has a negative predictive value of 96% for ASGES <=15 in a population referred to myocardial perfusion imaging.

Sponsors and collaborators

Lead sponsor

CardioDx

Industry

Registry information

Official study title

Investigation of a Molecular Personalized Coronary Gene Expression Test (Corus CAD or ASGES) on Primary Care Practice Pattern

Acronym: IMPACT-PCP

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
May 9, 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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