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N/A N=251

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

Chest Pain · Cardiovascular Diseases · Angina Pectoris · Coronary Artery Disease · CAD

Enrolled (actual)
251
Serious AEs
0.0%
Results posted
Apr 2014
Primary outcome: Primary: Change in Clinicians' Treatment Decision After Age/Sex/Gene Expression Score — 38; 1; 1; 0 number of subjects — p=<0.001

Study Design & Population

Study type
Observational
Phase
N/A
Interventions
Corus CAD (Diagnostic_test)
Age
Adult, Older Adult · 21+ yrs
Sex
All
Sponsor
CardioDx
Primary completion
Jan 2013

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Clinicians' Treatment Decision After Age/Sex/Gene Expression Score
38; 1; 1; 0; 3; 1 <0.001 sig

Summary

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.

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01594411). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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