Utility of a Molecular Personalized Coronary Gene Expression Test (Corus CAD or ASGES) on Cardiology Practice Pattern

NCT ID: NCT01251302

Last Updated: 2019-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

171 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-11-30

Study Completion Date

2012-06-30

Brief Summary

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To investigate whether the use of Corus CAD (Age/Sex/Gene Expression score - ASGES) blood assay changes the diagnostic testing pattern in patients referred to a cardiologist for the evaluation of chest pain or anginal equivalent symptoms.

Detailed Description

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A prospective cohort of 88 subjects receiving the Corus CAD (Age/Sex/Gene Expression score - ASGES) assay were compared to a retrospective cohort of 83 subjects that did not receive the assay.

Conditions

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Angina Pectoris Coronary Artery Disease Chest Pain Cardiovascular Diseases Coronary Heart Disease CAD CVD CHD

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Prospective Cohort

Patient presenting with chest pain or anginal equivalent and receiving a resulted age, sex and gene expression score (ASGES) to assist in diagnosis.

Corus CAD (ASGES)

Intervention Type DIAGNOSTIC_TEST

Age/Sex/Gene Expression Score - ASGES

Retrospective Cohort

Patients presenting with chest pain or anginal equivalent who did not receive an age, sex and gene expression score (ASGES) to assist in diagnosis. Note: this cohort was historical.

No interventions assigned to this group

Interventions

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Corus CAD (ASGES)

Age/Sex/Gene Expression Score - ASGES

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

1. Stable chest pain, typical or atypical angina or anginal equivalent
2. The patient has signed the appropriate Institutional Review Board approved Informed Consent Form.

Exclusion Criteria

1. History of myocardial infarction
2. Current myocardial infarct (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:

1. Diabetes
2. Suspected unstable angina
3. Systemic infections
4. Systemic inflammatory conditions
6. Any individuals currently taking:

1. Steroids
2. Immunosuppressive agents
3. Chemotherapeutic agents
7. Recipient of any organ transplant
Minimum Eligible Age

21 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CardioDx

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Zapien, MS

Role: STUDY_DIRECTOR

CardioDx, Inc.

Locations

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Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status

Countries

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United States

References

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McPherson JA, Davis K, Yau M, Beineke P, Rosenberg S, Monane M, Fredi JL. The clinical utility of gene expression testing on the diagnostic evaluation of patients presenting to the cardiologist with symptoms of suspected obstructive coronary artery disease: results from the IMPACT (Investigation of a Molecular Personalized Coronary Gene Expression Test on Cardiology Practice Pattern) trial. Crit Pathw Cardiol. 2013 Jun;12(2):37-42. doi: 10.1097/HPC.0b013e3182822bd0.

Reference Type RESULT
PMID: 23680805 (View on PubMed)

Other Identifiers

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IMPACT-CARD

Identifier Type: OTHER

Identifier Source: secondary_id

CDX_000011

Identifier Type: -

Identifier Source: org_study_id

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