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OpenTrials
Completed

NCT Number: NCT01251302

Utility of a Molecular Personalized Coronary Gene Expression Test (Corus CAD or ASGES) on Cardiology Practice Pattern

To investigate whether the use of Corus CAD (Age/Sex/Gene Expression score - ASGES) blood assay changes the diagnostic testing pattern in patients referred to a cardiologist for the evaluation of chest pain or anginal equivalent symptoms.

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Key information

Conditions

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

Age range

21 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

About this study

A prospective cohort of 88 subjects receiving the Corus CAD (Age/Sex/Gene Expression score - ASGES) assay were compared to a retrospective cohort of 83 subjects that did not receive the assay.

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 infarct (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
  • Recipient of any organ transplant

Treatment and study plan

Corus CAD (ASGES)

Diagnostic Test

Age/Sex/Gene Expression Score - ASGES

Primary outcomes

  1. Change in management practice pattern between preliminary and after Corus CAD (ASGES) decision

    Time frame: Up to 7 days

    Change in management pattern comparing the preliminary and after Corus CAD (ASGES) decision will be measured by the number of subjects with medical management downgrade or upgrade within the following predefined categories:

    • No further cardiac testing or treatment
    • Medical therapy for angina or non-cardiac chest pain
    • Stress testing with or without imaging
    • CT angiography
    • Invasive cardiac catheterization

  2. Change in management practice pattern between after Corus CAD decision and historical cohort.

    Time frame: up to 195 days

    Change in management pattern comparing the Corus CAD (ASGES) driven decision and the historical cohort ill be measured by the number of subjects with medical management downgrade or upgrade within the following predefined categories:

    • No further cardiac testing or treatment
    • Medical therapy for angina or non-cardiac chest pain
    • Stress testing with or without imaging
    • CT angiography
    • Invasive cardiac catheterization

Sponsors and collaborators

Lead sponsor

CardioDx

Industry

Registry information

Official study title

Investigation of a Molecular Personalized Coronary Gene Expression Test on Cardiology Practice Pattern

Acronym: IMPACT-CARD

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Dec 1, 2010
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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