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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01557855
Other study ID # CDX_000013
Secondary ID REGISTRY-I
Status Completed
Phase
First received
Last updated
Start date April 2012
Est. completion date May 2013

Study information

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

Clinical Trial Summary

The objective of this study is to collect data on the commercial use of Corus CAD (Age/Sex/Gene Expression score - ASGES) blood test to evaluate the clinical referral patterns of Primary Care Physicians after receipt of their patients' Corus Score, and to better understand patient management patterns for clinicians ordering the test.


Description:

This is a prospective, multicenter observational registry collecting and analyzing commercial utilization data of the Corus CAD assay ("Test") also known as Age/Sex/Gene Expression score (ASGES) . The study will prospectively enroll approximately 670 evaluable subjects from qualified sites and evaluate the rate of referral versus Corus CAD (ASGES) score as continuous variables.

Objective of the study is to assess whether the score provided by the Corus CAD (Age/Sex/Gene Expression score - ASGES) test has an effect on the Primary Care Physician's patient management and referral patterns once received:

1. No further cardiac testing or treatment

2. Medical therapy for angina or non-cardiac chest pain

3. Referral to a cardiologist for stress testing with or without imaging, CT angiography, or invasive cardiac catheterization.

Since it takes approximately two days for the physician to receive the result of the Corus CAD (Age/Sex/Gene Expression score - ASGES) , initial diagnostic testing will reflect local standard of care.


Recruitment information / eligibility

Status Completed
Enrollment 342
Est. completion date May 2013
Est. primary completion date March 2013
Accepts healthy volunteers No
Gender All
Age group 21 Years and older
Eligibility Inclusion Criteria:

1. Patients with symptoms suggestive of CAD, including typical or atypical angina or angina equivalent

2. The patient has signed the appropriate Institutional Review Board approved Informed Consent Form

Exclusion Criteria:

1. History of myocardial infarction

2. Current MI or acute coronary syndrome

3. Current New York Heart Association (NYHA) class III or IV congestive heart failure symptoms

4. Any previous coronary Revascularization

5. Any individuals with:

- Diabetes

- Suspected unstable angina

- Systemic infections

- Systemic inflammatory conditions

6. Any individuals currently taking:

- Steroids

- Immunosuppressive agents

- Chemotherapeutic agents

7. Recipient of any organ transplant

Study Design


Intervention

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

Locations

Country Name City State
United States Arizona Sun Family Medicine Gilbert Arizona
United States Maringouin Medical Center Maringouin Louisiana
United States Fiel Family Medicine Tempe Arizona
United States Triangle Primary Care Wake Forest North Carolina
United States Town Lake Internal Medicine Woodstock Georgia
United States Comprehensive Physicians Associates Youngstown Ohio
United States The Bonin Clinic Zachary Louisiana

Sponsors (1)

Lead Sponsor Collaborator
CardioDx

Country where clinical trial is conducted

United States, 

References & Publications (1)

Ladapo JA, Lyons H, Yau M, Rich P, Newton D, Bruce-Mensah K, Johnson A, Zhou Y, Stemkowski S, Monane M. Enhanced assessment of chest pain and related symptoms in the primary care setting through the use of a novel personalized medicine genomic test: resul — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of referral vs. Corus CAD (ASGES) score as continuous variables Composite endpoint consisting of referrals to a cardiologist, to cardiac stress/CTA and/or to invasive cardiac catheterization occurring between Day 0 and Day 30 + 15 days. 30 Days
Secondary Rate of referral difference between low Corus CAD or ASGES (</=15) and non-low ASGES (>15) scores. composite endpoint consisting of referrals to a cardiologist, to cardiac stress/CTA, and/or referral to invasive cardiac catheterization at Day 30 +15 days. 30 Day
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