PCP Use of a Gene Expression Test (Corus CAD or ASGES) in Coronary Artery Disease Diagnosis

NCT ID: NCT01594411

Last Updated: 2019-01-31

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 251 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2013-02-28

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.

Conditions

Chest Pain; Cardiovascular Diseases; Angina Pectoris; Coronary Artery Disease; CAD; CVD; CHD; Coronary Heart Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

All subjects

Subjects are enrolled at multiple participating primary care practices. The main inclusion criterion for enrollment is the occurrence of chest pain (or anginal equivalent) in a patient without known significant coronary artery disease (CAD) or a history of prior myocardial infarction.

Corus CAD

Intervention Type: DIAGNOSTIC_TEST

Age/Sex/Gene Expression Score (ASGES)

Interventions

Corus CAD

Age/Sex/Gene Expression Score (ASGES)

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CardioDx

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

May Yau, MS

Role: STUDY_DIRECTOR

CardioDx

Locations

John's Creek Primary Care

Suwanee, Georgia, United States

The Lipid Center

Baton Rouge, Louisiana, United States

Carolina Family Healthcare

Charlotte, North Carolina, United States

Family Care Clinic

Bonham, Texas, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 24610188 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 25828395 (View on PubMed)

Other Identifiers

IMPACT-PCP

Identifier Type: OTHER

Identifier Source: secondary_id

CDX_000014

Identifier Type: -

Identifier Source: org_study_id