NCT01117506

Coronary Obstruction Detection by Molecular Personalized Gene Expression (Corus CAD or ASGES)

A Blood-based Gene Expression Test (Corus CAD or ASGES) for Obstructive Coronary Artery Disease Tested in Symptomatic Nondiabetic Patients Referred for Myocardial Perfusion Imaging.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 581 (actual)
• Sponsor: CardioDx · Industry
• Sex: All
• Age: 35 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

To validate the use of Corus CAD (Age/Sex/Gene Expression score - ASGES) blood assay in subjects who are referred for the work-up of coronary artery disease. The study will evaluate the clinical utility of a gene expression test Corus CAD (Age, Sex, Gene Expression Score - ASGES) in subjects referred for myocardial perfusion imaging (MPI) work-up for suspected obstructive atherosclerotic coronary artery disease (CAD). The Corus CAD (ASGES) is a gene expression test that quantify the expression of multiple genes from circulating peripheral blood cells to detect the presence of clinically significant obstructive CAD in patients with chest pain.

Detailed description

This prospective, multicenter study obtained peripheral blood samples for gene expression score (GES) before MPI in 537 consecutive patients Patients with abnormal MPI usually underwent invasive coronary angiography; all others had research coronary computed tomographic angiography, with core laboratories defining coronary anatomy A total of 431 patients completed GES, coronary imaging (invasive coronary angiography or computed tomographic angiography), and MPI Mean age was 56±10 years (48% women) The prespecified primary end point was GES receiver-operating characteristics analysis to discriminate ≥50% stenosis (15% prevalence by core laboratory analysis) Area under the receiver-operating characteristics curve for GES was 0 79 (95% confidence interval, 0 73-0 84; P\<0 001), with sensitivity, specificity, and negative predictive value of 89%, 52%, and 96%, respectively, at a prespecified threshold of ≤15 with 46% of patients below this score The GES outperformed clinical factors by receiver-operating characteristics and reclassification analysis and showed significant correlation with maximum percent stenosis. Six-month follow-up on 97% of patients showed that 27 of 28 patients with adverse cardiovascular events or revascularization had GES \>15 Site and core-laboratory MPI had areas under the curve of 0 59 and 0 63, respectively, significantly less than GES.

Conditions

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

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Corus CAD (ASGES)	Age/Sex/Gene Expression Score - ASGES

Timeline

• Start date: 2010-04-01
• Primary completion: 2011-05-01
• Completion: 2012-05-01
• First posted: 2010-05-05
• Last updated: 2019-01-31

Locations

7 sites across 1 country: United States