Clinical trial NCT01557855: Investigation of a Novel Gene Expression Test (ASGES or Corus CAD) for Diagnosis of Obstructive Coronary Artery Disease
Official title: Enhanced Assessment of Chest Pain and Related Symptoms in the Primary Care Setting Through the Use of a Novel Personalized Medicine Genomic Test: Results From a Prospective Registry Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Angina Pectoris
Chest Pain
Cardiovascular Diseases
Coronary Heart Disease
CAD
CVD
CHD
Keywords: Corus CAD
ASGES
Age/Sex/Gene Expression Score
Gene Expression
GES
CAD
CVD
CHD
Precision Medicine
Clinical Utility
Registry
Coronary Artery Disease
Coronary Heart Disease
Cardiovascular Disease
Angina Pectoris
Chest Pain
Registry I
Registry-I
Lead sponsor: CardioDx
Sponsor class: INDUSTRY
First posted: 2012-03-20
Enrollment: 342
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: Subjects will be enrolled at multiple qualified participating study centers that have incorporated Corus CAD (ASGES) for the diagnosis of obstructive CAD into their routine practice.

Brief summary: The objective of this study is to collect data on the commercial use of Corus CAD (Age/Sex/Gene Expression score - ASGES) blood test to evaluate the clinical referral patterns of Primary Care Physicians after receipt of their patients' Corus Score, and to better understand patient management patterns for clinicians ordering the test.

Detailed description: This is a prospective, multicenter observational registry collecting and analyzing commercial utilization data of the Corus CAD assay ("Test") also known as Age/Sex/Gene Expression score (ASGES) . The study will prospectively enroll approximately 670 evaluable subjects from qualified sites and evaluate the rate of referral versus Corus CAD (ASGES) score as continuous variables.

Objective of the study is to assess whether the score provided by the Corus CAD (Age/Sex/Gene Expression score - ASGES) test has an effect on the Primary Care Physician's patient management and referral patterns once received:

1. No further cardiac testing or treatment
2. Medical therapy for angina or non-cardiac chest pain
3. Referral to a cardiologist for stress testing with or without imaging, CT angiography, or invasive cardiac catheterization.

Since it takes approximately two days for the physician to receive the result of the Corus CAD (Age/Sex/Gene Expression score - ASGES) , initial diagnostic testing will reflect local standard of care.

Eligibility criteria: Inclusion Criteria:

1. Patients with symptoms suggestive of CAD, including typical or atypical angina or angina equivalent
2. The patient has signed the appropriate Institutional Review Board approved Informed Consent Form

Exclusion Criteria:

1. History of myocardial infarction
2. Current 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. Recipient of any organ transplant

Primary outcomes:
measure: Rate of referral vs. Corus CAD (ASGES) score as continuous variables
timeFrame: 30 Days
Secondary outcomes:
measure: Rate of referral difference between low Corus CAD or ASGES (</=15) and non-low ASGES (>15) scores.
timeFrame: 30 Day
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Arizona Sun Family Medicine
state: Arizona
city: Tempe
country: United States
facility: Fiel Family Medicine
state: Arizona
city: Woodstock
country: United States
facility: Town Lake Internal Medicine
state: Georgia
city: Maringouin
country: United States
facility: Maringouin Medical Center
state: Louisiana
city: Zachary
country: United States
facility: The Bonin Clinic
state: Louisiana
city: Wake Forest
country: United States
facility: Triangle Primary Care
state: North Carolina
city: Youngstown
country: United States
facility: Comprehensive Physicians Associates
state: Ohio
Study officials:
affiliation: CardioDx
name: Michael Zapien, MS
role: STUDY_DIRECTOR
References:
citation: Ladapo JA, Lyons H, Yau M, Rich P, Newton D, Bruce-Mensah K, Johnson A, Zhou Y, Stemkowski S, Monane M. Enhanced assessment of chest pain and related symptoms in the primary care setting through the use of a novel personalized medicine genomic test: results from a prospective registry study. Am J Med Qual. 2015 Jul-Aug;30(4):345-52. doi: 10.1177/1062860614532517. Epub 2014 May 5.
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.