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

Coronary Artery Disease Clinical Trial

— IMPACT-CARD  

Official title:

Investigation of a Molecular Personalized Coronary Gene Expression Test on Cardiology Practice Pattern

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01251302
• Other study ID #: CDX_000011
• Secondary ID: IMPACT-CARD
• Status: Completed
• Start date: November 2010
• Est. completion date: June 2012

Study information

• Verified date: January 2019
• Source: CardioDx
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 171
• Est. completion date: June 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Angina Pectoris
• CAD
• Cardiovascular Diseases
• CHD
• Chest Pain
• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• CVD
• Heart Diseases
• Myocardial Ischemia

Intervention

Diagnostic Test:
• Corus CAD (ASGES)
Age/Sex/Gene Expression Score - ASGES

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
CardioDx

Country where clinical trial is conducted

United States, 

References & Publications (1)

McPherson JA, Davis K, Yau M, Beineke P, Rosenberg S, Monane M, Fredi JL. The clinical utility of gene expression testing on the diagnostic evaluation of patients presenting to the cardiologist with symptoms of suspected obstructive coronary artery diseas — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in management practice pattern between preliminary and after Corus CAD (ASGES) decision	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: No further cardiac testing or treatment; Medical therapy for angina or non-cardiac chest pain; Stress testing with or without imaging; CT angiography; Invasive cardiac catheterization	Up to 7 days
Primary	Change in management practice pattern between after Corus CAD decision and historical cohort.	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: No further cardiac testing or treatment; Medical therapy for angina or non-cardiac chest pain; Stress testing with or without imaging; CT angiography; Invasive cardiac catheterization	up to 195 days