Clinical trial NCT02405754: Clinical Utility of an Age, Sex, and Gene Expression Score (ASGES or Corus CAD) in African American Patients.
Official title: Clinical Utility of an Age, Sex and Gene Expression Score (ASGES or Corus CAD) in the Diagnostic Management of Obstructive Coronary Artery Disease in African American Patients in a Primary Care Setting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Angina Pectoris
Chest Pain
Cardiovascular Diseases
Coronary Heart Disease
CHD
CVD
CAD
Keywords: Corus CAD
Personalized Medicine
CAD
ASGES
Age/Sex/Gene Expression Score
GES
CVD
CHD
Precision Medicine
Clinical Utility
Gene Expression
Coronary Heart Disease
Cardiovascular Disease
Chest Pain
Coronary Artery Disease
Angina Pectoris
exercise stress testing
CT angiography
invasive cardiac angiography
African-American patient
ICA
CTA
Lead sponsor: CardioDx
Sponsor class: INDUSTRY
First posted: 2015-04-01
Enrollment: 667
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects, who received Age/Sex/Gene Expression Score (ASGES) or Corus CAD testing, will be considered for enrollment by conducting a retrospective review of medical charts. Subjects who satisfy the following inclusion and exclusion criteria will be included for data abstraction.

Brief summary: This is a retrospective study, designed to be conducted at a single-center in the US. The study will conduct a one-time data abstraction from approximately 500 patient medical charts who received Age/Sex/Gene Expression score (ASGES) also knows as Corus CAD testing, by order of the Principal Investigator. Limited demographic data and patient data pertaining to cardiology referral or advanced diagnostic testing will be collected. All data will be collected anonymously.

Detailed description: Though the diagnostic properties of Age/Sex/Gene Expression Score (ASGES) or Corus CAD have been evaluated in previous observational studies, there are limited data regarding how primary care clinicians are using the results of the test in the care and management of patients with symptoms suggestive of angina in the African-America patient population. This retrospective study is designed to examine the relationship between the Corus CAD (ASGES) score and patterns of care regarding cardiology referral or further cardiac diagnostic testing in an African-American patient population single-center site.

This is a retrospective study, designed to be conducted at a single-center in the US. The study will conduct a one-time data abstraction from approximately 500 patient medical charts who received Corus CAD (ASGES) testing, by order of the Principal Investigator. Limited demographic data and patient data pertaining to cardiology referral or advanced diagnostic testing will be collected. All data will be collected anonymously. IRB approval will be requested with a waiver of informed consent, as no identifying information will be collected.

This retrospective study is designed to understand the patterns of care, including referrals for cardiac care and testing (including referrals to a cardiologist, exercise stress testing, cardiac computerized tomography angiography (CCTA), invasive cardiac angiography (ICA)) within an African-American patient population.

Eligibility criteria: Inclusion Criteria:

* All patients receiving Corus CAD (ASGES) from 2008-2012.

Exclusion Criteria:

* If any of the following co-moribidities, medical conditions, or current medical statuses are noted in the patient medical chart, s/he will be excluded from the analysis dataset:

  1. History of diabetes;
  2. Revascularization or myocardial infarction;
  3. Systemic infection or inflammatory condition; or
  4. Use of steroids, immunosuppressive agents, or chemotherapeutic agents.

Primary outcomes:
measure: Referral rate of patients receiving Age/Sex/Gene Expression Score (ASGES) or Corus CAD
timeFrame: Expected follow-up up to 1 year after receiving Corus CAD testing
Secondary outcomes:
Other outcomes:
Locations:
city: Dayton
country: United States
facility: Providence Medical Group - Dayton Primary
state: Ohio
Study officials:
affiliation: CardioDx, Inc.
name: Linda Ross, MPH
role: STUDY_DIRECTOR
References: