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
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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COMPLETED
171 participants
OBSERVATIONAL
2010-11-30
2012-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
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)
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
Eligibility Criteria
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Inclusion Criteria
2. The patient has signed the appropriate Institutional Review Board approved Informed Consent Form.
Exclusion Criteria
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
21 Years
99 Years
ALL
No
Sponsors
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CardioDx
INDUSTRY
Responsible Party
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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
Countries
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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.
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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