Utility of a Molecular Personalized Coronary Gene Expression Test (Corus CAD or ASGES) on Cardiology Practice Pattern (IMPACT-CARD)

CardioDx

Status: Completed

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

Treatments: Diagnostic Test: Corus CAD (ASGES)

Study type: Observational

Funder types: Industry

Identifiers

NCT01251302

IMPACT-CARD (Other Identifier)

CDX_000011

Details and patient eligibility

About

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.

Full 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.

Enrollment: 171 patients

Sex: All

Ages: 21 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

171 participants in 2 patient groups

Prospective Cohort

Description:

Patient presenting with chest pain or anginal equivalent and receiving a resulted age, sex and gene expression score (ASGES) to assist in diagnosis.

Treatment:

Diagnostic Test: Corus CAD (ASGES)

Retrospective Cohort

Description:

Patients presenting with chest pain or anginal equivalent who did not receive an age, sex and gene expression score (ASGES) to assist in diagnosis. Note: this cohort was historical.