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

Completed

• Conditions: Coronary Heart Disease; Cardiovascular Diseases; CVD; Chest Pain; Angina Pectoris; Coronary Artery Disease; CAD; CHD
• Interventions: Diagnostic Test: Corus CAD (ASGES)

• Registration Number: NCT01251302
• Lead Sponsor: CardioDx

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2010-11-30
• Study First Submitted QC: 2010-11-30
• Study First Posted: 2010-12-01
• Primary Completion: 2012-02
• Study Completion: 2012-06
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-29
• Last Update Posted: 2019-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 171

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Prospective Cohort	Corus CAD (ASGES)	Patient presenting with chest pain or anginal equivalent and receiving a resulted age, sex and gene expression score (ASGES) to assist in diagnosis.

Primary Outcome Measures

Name	Time	Method
Change in management practice pattern between preliminary and after Corus CAD (ASGES) decision	Up to 7 days	Change in management pattern comparing the preliminary and after Corus CAD (ASGES) decision will be measured by the number of subjects with medical management downgrade or upgrade within the following predefined categories: 1. No further cardiac testing or treatment; 2. Medical therapy for angina or non-cardiac chest pain; 3. Stress testing with or without imaging; 4. CT angiography; 5. Invasive cardiac catheterization
Change in management practice pattern between after Corus CAD decision and historical cohort.	up to 195 days	Change in management pattern comparing the Corus CAD (ASGES) driven decision and the historical cohort ill be measured by the number of subjects with medical management downgrade or upgrade within the following predefined categories: 1. No further cardiac testing or treatment; 2. Medical therapy for angina or non-cardiac chest pain; 3. Stress testing with or without imaging; 4. CT angiography; 5. Invasive cardiac catheterization

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States