Clinical trial NCT01251302: Utility of a Molecular Personalized Coronary Gene Expression Test (Corus CAD or ASGES) on Cardiology Practice Pattern
Official title: Investigation of a Molecular Personalized Coronary Gene Expression Test on Cardiology Practice Pattern
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Angina Pectoris
Coronary Artery Disease
Chest Pain
Cardiovascular Diseases
Coronary Heart Disease
CAD
CVD
CHD
Keywords: Corus CAD
Age/Sex/Gene Expression Score
Molecular Genetics
Atherosclerosis
ASGES
Gene Expression
GES
CAD
CVD
CHD
Clinical Utility
Precision Medicine
Coronary Artery Disease
Angina Pectoris
Chest Pain
Cardiovascular Disease
Coronary Heart Disease
IMPACT
IMPACT-CARD
Lead sponsor: CardioDx
Sponsor class: INDUSTRY
First posted: 2010-12-01
Enrollment: 171
Sex: ALL
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study will enroll a patient population that present with chest pain or anginal equivalent symptoms who are referred to a cardiologist for evaluation.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. History of myocardial infarction
2. Current myocardial infarct (MI) or acute coronary syndrome
3. Current New York Heart Association (NYHA) class III or IV congestive heart failure symptoms
4. Any previous coronary revascularization
5. Any individuals with:

   1. Diabetes
   2. Suspected unstable angina
   3. Systemic infections
   4. Systemic inflammatory conditions
6. Any individuals currently taking:

   1. Steroids
   2. Immunosuppressive agents
   3. Chemotherapeutic agents
7. Recipient of any organ transplant

Primary outcomes:
measure: Change in management practice pattern between preliminary and after Corus CAD (ASGES) decision
timeFrame: Up to 7 days
measure: Change in management practice pattern between after Corus CAD decision and historical cohort.
timeFrame: up to 195 days
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: CardioDx, Inc.
name: Michael Zapien, MS
role: STUDY_DIRECTOR
References:
citation: McPherson JA, Davis K, Yau M, Beineke P, Rosenberg S, Monane M, Fredi JL. The clinical utility of gene expression testing on the diagnostic evaluation of patients presenting to the cardiologist with symptoms of suspected obstructive coronary artery disease: results from the IMPACT (Investigation of a Molecular Personalized Coronary Gene Expression Test on Cardiology Practice Pattern) trial. Crit Pathw Cardiol. 2013 Jun;12(2):37-42. doi: 10.1097/HPC.0b013e3182822bd0.