Viewing Study NCT02405754



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Last Modification Date: 2024-10-26 @ 11:40 AM
Study NCT ID: NCT02405754
Status: COMPLETED
Last Update Posted: 2019-01-31
First Post: 2015-03-23

Brief Title: Clinical Utility of an Age Sex and Gene Expression Score ASGES or Corus CAD in African American Patients
Sponsor: CardioDx
Organization: CardioDx

Study Overview

Official Title: Clinical Utility of an Age Sex and Gene Expression Score ASGES or Corus CAD in the Diagnostic Management of Obstructive Coronary Artery Disease in African American Patients in a Primary Care Setting
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: AACU
Brief Summary: This is a retrospective study designed to be conducted at a single-center in the US The study will conduct a one-time data abstraction from approximately 500 patient medical charts who received AgeSexGene Expression score ASGES also knows as Corus CAD testing by order of the Principal Investigator Limited demographic data and patient data pertaining to cardiology referral or advanced diagnostic testing will be collected All data will be collected anonymously
Detailed Description: Though the diagnostic properties of AgeSexGene Expression Score ASGES or Corus CAD have been evaluated in previous observational studies there are limited data regarding how primary care clinicians are using the results of the test in the care and management of patients with symptoms suggestive of angina in the African-America patient population This retrospective study is designed to examine the relationship between the Corus CAD ASGES score and patterns of care regarding cardiology referral or further cardiac diagnostic testing in an African-American patient population single-center site

This is a retrospective study designed to be conducted at a single-center in the US The study will conduct a one-time data abstraction from approximately 500 patient medical charts who received Corus CAD ASGES testing by order of the Principal Investigator Limited demographic data and patient data pertaining to cardiology referral or advanced diagnostic testing will be collected All data will be collected anonymously IRB approval will be requested with a waiver of informed consent as no identifying information will be collected

This retrospective study is designed to understand the patterns of care including referrals for cardiac care and testing including referrals to a cardiologist exercise stress testing cardiac computerized tomography angiography CCTA invasive cardiac angiography ICA within an African-American patient population

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
AACU OTHER CardioDx None