Investigation of a Novel Gene Expression Test for the Diagnosis of Obstructive Coronary Artery Disease on Physician's Practice Pattern
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Purpose
The objective of this study is to collect data on the commercial use of CORUS® (validated quantitative in vitro diagnostic test) Coronary Artery Disease (CAD) 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.
| Condition |
|---|
|
Coronary Artery Disease |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Coronary Obstruction Detection by Molecular Personalized Gene Expression |
- Rate of referral vs. Corus score as continuous variables [ Time Frame: 30 Days ] [ Designated as safety issue: No ]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.
- Rate of referral difference between low Corus (</=15) and non-low Corus (>15) scores. [ Time Frame: 30 Day ] [ Designated as safety issue: No ]composite endpoint consisting of referrals to a cardiologist, to cardiac stress/CTA, and/or referral to invasive cardiac catheterization at Day 30 +15 days.
| Estimated Enrollment: | 670 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
Objective of the study is to assess whether the score provided by the CORUS® CAD test has an effect on the Primary Care Physician's patient management and referral patterns once received:
- no further cardiac testing or treatment
- medical therapy for angina or non-cardiac chest pain
- 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, initial diagnostic testing will reflect local standard of care
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Subjects will be enrolled at multiple qualified participating study centers that have incorporated CORUS CAD for the diagnosis of obstructive CAD into their routine practice.
Inclusion Criteria:
- Patients with symptoms suggestive of CAD, including typical or atypical angina or angina equivalent
- The patient has signed the appropriate Institutional Review Board approved Informed Consent Form
Exclusion Criteria:
- History of myocardial infarction
- Current MI or acute coronary syndrome
- Current New York Heart Association (NYHA) class III or IV congestive heart failure symptoms
- Any previous coronary Revascularization
Any individuals with:
- Diabetes
- Suspected unstable angina
- Systemic infections
- Systemic inflammatory conditions
Any individuals currently taking:
- Steroids
- Immunosuppressive agents
- Chemotherapeutic agents
- Recipient of any organ transplant
Contacts and Locations| Contact: May Yau | 650-475-2788 | myau@cardiodx.com |
| Contact: Elsa Hewlett | 650-475-2788 | ehewlett@cardiodx.com |
| United States, Arizona | |
| Arizona Sun Family Medicine | Recruiting |
| Gilbert, Arizona, United States, 85296 | |
| Contact: Rakesh Patel 480-222-1171 | |
| Principal Investigator: Rakesh Patel | |
| Fiel Family Medicine | Recruiting |
| Tempe, Arizona, United States, 85283 | |
| Contact: Belinda Ledesma 480-751-3777 | |
| Principal Investigator: Thomas Fiel, MD | |
| United States, Georgia | |
| Town Lake Internal Medicine | Recruiting |
| Woodstock, Georgia, United States, 30189 | |
| Contact: Thomas Hight 770-928-3132 | |
| Principal Investigator: Thomas Hight | |
| United States, Louisiana | |
| Maringouin Medical Center | Recruiting |
| Maringouin, Louisiana, United States, 70757 | |
| Contact: Dedra Newton 225-625-2313 maringouinmedical@gmail.com | |
| Principal Investigator: Dedra Newton | |
| The Bonin Clinic | Recruiting |
| Zachary, Louisiana, United States, 70791 | |
| Contact: Joey Bonin 225-570-2010 | |
| Principal Investigator: Joey Bonin | |
| United States, North Carolina | |
| Triangle Primary Care | Recruiting |
| Wake Forest, North Carolina, United States, 27587 | |
| Contact: Kofi Bruce-Menash, MD 919-554-3095 | |
| Principal Investigator: Kofi Bruce-Menash, MD | |
| United States, Ohio | |
| Comprehensive Physicians Associates | Recruiting |
| Youngstown, Ohio, United States, 44505 | |
| Contact: Paul Rich 330-759-2511 | |
| Principal Investigator: Paul Rich | |
| Study Director: | May Yau | CardioDx |
More Information
No publications provided
| Responsible Party: | CardioDx |
| ClinicalTrials.gov Identifier: | NCT01557855 History of Changes |
| Other Study ID Numbers: | CDX_000013 |
| Study First Received: | March 16, 2012 |
| Last Updated: | February 7, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases |
Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on May 23, 2013