Ignite Creation Date:
2024-05-06 @ 3:11 AM
Last Modification Date:
2024-10-26 @ 11:29 AM
Study NCT ID:
NCT02223286
Status:
COMPLETED
Last Update Posted:
2018-02-22
First Post:
2014-08-19
Brief Title:
Understanding Clinician Utilization of Corus CAD AgeSexGene Expression Score - ASGES in Clinical Decision Making
Sponsor:
CardioDx
Organization:
CardioDx
Study Overview
Official Title:
Understanding Clinician Utilization of Corus CAD AgeSexGene Expression Score - ASGES in Clinical Decision Making
Status:
COMPLETED
Status Verified Date:
2018-02
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:
UCU-CARD
Brief Summary:
The purpose of this study is to understand the use of Corus CAD also known as AgeSexGene Expression score ASGES in the clinical decision making process of patients who underwent the evaluation of chest pain or anginal equivalent symptoms Specifically to better understand whether the use of the assay in clinical decision making resulted in changes in noninvasive diagnostic test ordering or diagnostic yield of additional tests ordered andor invasive angiography
Detailed Description:
The UCU-CARD Understanding Clinician Utility-Cardiology study is a retrospective matched-cohort evaluation of diagnostic testing in a community-based cardiology practice setting that used a personalized age sex and gene expression test during early work-up of patients with symptoms suggestive of obstructive CAD httpwwwclinicaltrialsgov NCT02223286 The study measured the rates of advanced cardiac diagnostic testing after initial work-up including stress testing with imaging CTA or ICA Rates of advanced diagnostic testing for patients who received the age sex and gene expression test ASGES were compared with testing rates for matched historical controls usual care The study hypothesis was that incorporating the age sex and gene expression testing early in the diagnostic work-up pathway would permit the identification of patients for whom advanced diagnostic testing was not required thereby avoiding unnecessary testing and enabling cardiologists to focus their diagnostic resources more efficiently
This single-center study was conducted at the North Phoenix Heart Center Phoenix AZ a community-based group cardiology practice that receives patients on referral from primary care physicians and other specialists in the surrounding area The practice incorporated age sex and gene expression testing into its diagnostic protocol beginning in June 2011 Data collection was completed in December 2013 Institutional Review Board IRB approval of the study protocol was granted by Quorum Review Informed consent waivers were granted as data collection was retrospective and all data were de-identified
This single-center study was conducted at the North Phoenix Heart Center Phoenix AZ a community-based group cardiology practice that receives patients on referral from primary care physicians and other specialists in the surrounding area The practice incorporated age sex and gene expression testing into its diagnostic protocol beginning in June 2011 Data collection was completed in December 2013 Institutional Review Board IRB approval of the study protocol was granted by Quorum Review Informed consent waivers were granted as data collection was retrospective and all data were de-identified
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 |
|---|---|---|---|
| UCU-CARD | OTHER | CardioDx | None |