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
Bottom Line
View on ClinicalTrials.gov: NCT01594411 ↗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
| Outcome | Result | p-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
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.