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NCT01117506 · ClinicalTrials.gov registry record
Coronary Obstruction Detection by Molecular Personalized Gene Expression (Corus CAD or ASGES)
A clinical trial of Cardiovascular Diseases and Coronary Artery Disease, sponsored by CardioDx.
- Completed
- Registry status
- 581
- Enrollment target
- 7
- Study locations
NCT01117506: Completed study of Cardiovascular Diseases and Coronary Artery Disease, sponsored by CardioDx.
NCT01117506 is a study of Cardiovascular Diseases and Coronary Artery Disease that has completed, run by CardioDx. The registered enrollment target is 581 participants, below the 26,972-participant average among 300 other Cardiovascular Diseases trials with a reported enrollment target (98% lower). The trial reports 7 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01117506, a study of Cardiovascular Diseases and Coronary Artery Disease, has completed, sponsored by CardioDx.
- COMPLETED
- Registry status
- 581 participants
- Enrollment target
- 7
- Study locations
Study Summary
To validate the use of Corus CAD (Age/Sex/Gene Expression score - ASGES) blood assay in subjects who are referred for the work-up of coronary artery disease. The study will evaluate the clinical utility of a gene expression test Corus CAD (Age, Sex, Gene Expression Score - ASGES) in subjects referred for myocardial perfusion imaging (MPI) work-up for suspected obstructive atherosclerotic coronary artery disease (CAD). The Corus CAD (ASGES) is a gene expression test that quantify the expression of multiple genes from circulating peripheral blood cells to detect the presence of clinically significant obstructive CAD in patients with chest pain.
Primary Outcome
The primary endpoint for the COMPASS study is to assess whether the Corus CAD (ASGES) gene expression test performance is superior to an AUC of 0.5. The endpoint will be evaluated based on the current gold standard test for CAD, invasive coronary angiography, or a research CCTA after the subjects have undergone both the Corus CAD (ASGES) and MPI tests. Superiority will be assessed based upon demonstration of p\<0.05 testing of the Corus CAD (ASGES) AUC versus an AUC of 0.50.
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Corus CAD (ASGES)
Study Locations (7)
California
- Long Beach Memorial Hospital - Long Beach
- Sutter Roseville Medical Center - Roseville
Colorado
- Pikes Peak Cardiology - Boulder
Kansas
- Midwest Cardiology Associates - Overland Park
Missouri
- St. Luke's Hospital - Kansas City
Pennsylvania
- Berks Cardiologists, Ltd - Wyomissing
Virginia
- Cardiovascular Associates of Virginia - Midlothian
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 581 participants |
| Start Date | 2010-04 |
| Est. Completion | 2012-05 |
What the finished NCT01117506 record still lists
NCT01117506 is an observational study that tracks outcomes without assigning an intervention. The registered 581 participants enrollment target is mid-sized for trials with a published cap, below the 26,972-participant average among 300 other Cardiovascular Diseases trials with a reported enrollment target (98% lower).
The record links to 8 conditions, with Cardiovascular Diseases appearing as the primary indexed condition, and to 1 intervention - of which Corus CAD (ASGES) is the first listed.
NCT01117506 lists 7 locations in 6 states (California, Colorado, Kansas).
Frequently Asked Questions
What is clinical trial NCT01117506 about?
NCT01117506 is a clinical study titled "Coronary Obstruction Detection by Molecular Personalized Gene Expression (Corus CAD or ASGES)". To validate the use of Corus CAD (Age/Sex/Gene Expression score - ASGES) blood assay in subjects who are referred for the work-up of coronary artery disease. The study will evaluate the clinical utility of a gene expression test Corus CAD (Age, Sex, Gene Expression Score - ASGES) in subjects referre...
What is the current status of trial NCT01117506?
This trial is currently completed. The enrollment target is 581 participants. The study started on 2010-04. Estimated completion is 2012-05.
What conditions does trial NCT01117506 study?
This clinical trial studies the following conditions: Cardiovascular Diseases, Coronary Artery Disease, Chest Pain, Coronary Heart Disease, Angina Pectoris.
What interventions are being tested in trial NCT01117506?
The interventions under investigation include: Corus CAD (ASGES) (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT01117506?
This trial is sponsored by CardioDx, which has 11 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01117506 being conducted?
This trial has 7 study locations across California, Colorado, Kansas, Missouri, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT01117506's enrollment target sits among peer trials
581 86th of 300 higher than 215 of 300 other Cardiovascular Diseases trials
participants (enrollment target), bucketed by value
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