Clinical trial NCT01594411: PCP Use of a Gene Expression Test (Corus CAD or ASGES) in Coronary Artery Disease Diagnosis
Official title: Investigation of a Molecular Personalized Coronary Gene Expression Test (Corus CAD or ASGES) on Primary Care Practice Pattern
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chest Pain
Cardiovascular Diseases
Angina Pectoris
Coronary Artery Disease
CAD
CVD
CHD
Coronary Heart Disease
Keywords: Corus CAD
ASGES
Age/Sex/Gene Expression Score
Gene Expression
GES
CAD
CVD
CHD
Clinical Utility
Precision Medicine
Primary care
Coronary Artery Disease
Angina Pectoris
Chest Pain
Cardiovascular Disease
Coronary Heart Disease
IMPACT
IMPACT-PCP
Lead sponsor: CardioDx
Sponsor class: INDUSTRY
First posted: 2012-05-09
Enrollment: 251
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief 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.

Detailed description: 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.

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 infarction (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 :

   * Diabetes
   * Suspected unstable angina
   * Systemic infections
   * Systemic inflammatory conditions
6. Any individuals currently taking:

   * Steroids
   * Immunosuppressive agents
   * Chemotherapeutic agents
7. Any Major Surgery within 2 months

Primary outcomes:
measure: Change in Clinicians' Treatment Decision After Age/Sex/Gene Expression Score
timeFrame: pre- and post- gene expression testing results (on average 2-3 days to receive ASGES)
Secondary outcomes:
Other outcomes:
Locations:
city: Suwanee
country: United States
facility: John's Creek Primary Care
state: Georgia
city: Baton Rouge
country: United States
facility: The Lipid Center
state: Louisiana
city: Charlotte
country: United States
facility: Carolina Family Healthcare
state: North Carolina
city: Bonham
country: United States
facility: Family Care Clinic
state: Texas
Study officials:
affiliation: CardioDx
name: May Yau, MS
role: STUDY_DIRECTOR
References:
citation: Herman L, Froelich J, Kanelos D, St Amant R, Yau M, Rhees B, Monane M, McPherson J. Utility of a genomic-based, personalized medicine test in patients presenting with symptoms suggesting coronary artery disease. J Am Board Fam Med. 2014 Mar-Apr;27(2):258-67. doi: 10.3122/jabfm.2014.02.130155.
citation: Ladapo JA, Herman L, Weiner BH, Rhees B, Castle L, Monane M, McPherson JA. Use of a blood test incorporating age, sex, and gene expression influences medical decision-making in the evaluation of women presenting with symptoms suggestive of obstructive coronary artery disease: summary results from two ambulatory care studies in primary care. Menopause. 2015 Nov;22(11):1224-30. doi: 10.1097/GME.0000000000000443.