跳至主要内容
临床试验/NCT02405754
NCT02405754已完成不适用

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

CardioDx1 个研究点 分布在 1 个国家目标入组 667 人开始时间: 2014年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
CardioDx
入组人数
667
试验地点
1
主要终点
Referral rate of patients receiving Age/Sex/Gene Expression Score (ASGES) or Corus CAD

研究概览

简要总结

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 Age/Sex/Gene 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.

详细描述

Though the diagnostic properties of Age/Sex/Gene 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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients receiving Corus CAD (ASGES) from 2008-2012.

排除标准

  • If any of the following co-moribidities, medical conditions, or current medical statuses are noted in the patient medical chart, s/he will be excluded from the analysis dataset:
  • History of diabetes;
  • Revascularization or myocardial infarction;
  • Systemic infection or inflammatory condition; or
  • Use of steroids, immunosuppressive agents, or chemotherapeutic agents.

结局指标

主要结局

Referral rate of patients receiving Age/Sex/Gene Expression Score (ASGES) or Corus CAD

时间窗: Expected follow-up up to 1 year after receiving Corus CAD testing

Referral rate of patients receiving Age/Sex/Gene Expression Score (ASGES) or Corus CAD , expected follow-up up to 1 year

次要结局

未报告次要终点

研究者

发起方
CardioDx
申办方类型
Industry
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验