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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02405754
Other study ID # CDX_000024
Secondary ID AACU
Status Completed
Phase
First received
Last updated
Start date February 2014
Est. completion date August 2014

Study information

Verified date January 2019
Source CardioDx
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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 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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 667
Est. completion date August 2014
Est. primary completion date April 2014
Accepts healthy volunteers No
Gender All
Age group 21 Years and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- 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:

1. History of diabetes;

2. Revascularization or myocardial infarction;

3. Systemic infection or inflammatory condition; or

4. Use of steroids, immunosuppressive agents, or chemotherapeutic agents.

Study Design


Intervention

Diagnostic Test:
Corus CAD (ASGES)
Age/Sex/Gene Expression Score - ASGES

Locations

Country Name City State
United States Providence Medical Group - Dayton Primary Dayton Ohio

Sponsors (1)

Lead Sponsor Collaborator
CardioDx

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Referral rate of patients receiving Age/Sex/Gene Expression Score (ASGES) or Corus CAD Referral rate of patients receiving Age/Sex/Gene Expression Score (ASGES) or Corus CAD , expected follow-up up to 1 year Expected follow-up up to 1 year after receiving Corus CAD testing
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