Ignite Creation Date:
2024-05-05 @ 10:29 PM
Last Modification Date:
2024-10-26 @ 10:19 AM
Study NCT ID:
NCT01117506
Status:
COMPLETED
Last Update Posted:
2019-01-31
First Post:
2010-05-03
Brief Title:
Coronary Obstruction Detection by Molecular Personalized Gene Expression Corus CAD or ASGES
Sponsor:
CardioDx
Organization:
CardioDx
Study Overview
Official Title:
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
Status Verified Date:
2019-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COMPASS
Brief Summary:
To validate the use of Corus CAD AgeSexGene 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 5610 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 P0 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| COMPASS | OTHER | CardioDx | None |