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Coronary Obstruction Detection by Molecular Personalized Gene Expression (Corus CAD or ASGES) (COMPASS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01117506
First Posted: May 5, 2010
Last Update Posted: October 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Cardiovascular Research Foundation, New York
Piedmont Heart Institute, Inc., Atlanta, GA
Information provided by (Responsible Party):
CardioDx
  Purpose
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 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.

Condition Intervention
Coronary Artery Disease Chest Pain Cardiovascular Diseases Coronary Heart Disease Angina Pectoris CAD CVD CHD Diagnostic Test: Corus CAD

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Blood-based Gene Expression Test (Corus CAD or ASGES) for Obstructive Coronary Artery Disease Tested in Symptomatic Nondiabetic Patients Referred for Myocardial Perfusion Imaging.

Resource links provided by NLM:


Further study details as provided by CardioDx:

Primary Outcome Measures:
  • To determine the accuracy of Corus CAD (ASGES) in identifying the likelihood of obstructive CAD in a patient population with chest pain who are referred to a clinically-indicated myocardial profusion stress test. [ Time Frame: Up to 45 days ]
    The primary endpoint for the COMPASS study is to assess whether the Corus CAD 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 and MPI tests. Superiority will be assessed based upon demonstration of p<0.05 testing of the Corus CAD AUC versus an AUC of 0.50.


Biospecimen Retention:   Samples With DNA
RNA PAXgene

Enrollment: 581
Study Start Date: April 2010
Study Completion Date: May 2012
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Diagnostic Test: Corus CAD
    Age/Sex/Gene Expression Score
Detailed Description:
This prospective, multicenter study obtained peripheral blood samples for gene expression score (GES) before MPI in 537 consecutive patients Patients with abnormal MPI usually underwent invasive coronary angiography; all others had research coronary computed tomographic angiography, with core laboratories defining coronary anatomy A total of 431 patients completed GES, coronary imaging (invasive coronary angiography or computed tomographic angiography), and MPI Mean age was 56±10 years (48% women) The prespecified primary end point was GES receiver-operating characteristics analysis to discriminate ≥50% stenosis (15% prevalence by core laboratory analysis) Area under the receiver-operating characteristics curve for GES was 0 79 (95% confidence interval, 0 73-0 84; P<0 001), with sensitivity, specificity, and negative predictive value of 89%, 52%, and 96%, respectively, at a prespecified threshold of ≤15 with 46% of patients below this score The GES outperformed clinical factors by receiver-operating characteristics and reclassification analysis and showed significant correlation with maximum percent stenosis. Six-month follow-up on 97% of patients showed that 27 of 28 patients with adverse cardiovascular events or revascularization had GES >15 Site and core-laboratory MPI had areas under the curve of 0 59 and 0 63, respectively, significantly less than GES.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The study will enroll a patient population that presents with stable chest pain syndrome or anginal equivalent and referred for stress myocardial profusion imaging.
Criteria

Inclusion Criteria:

  • Ages 45-90 for women; 35-90 for men.
  • Stable chest pain syndrome (typical or atypical) or anginal equivalent in the judgment of the investigator (e.g., pain in the neck, jaw, arm or shoulder or dyspnea possibly due to cardiac ischemia).
  • Referred for a stress test using MPI.
  • The patient has signed the appropriate Institutional Review Board approved Informed Consent Form.

Exclusion Criteria:

  • History of known MI or significant CAD.
  • Current MI or acute coronary syndrome.
  • Current New York Heart Association (NYHA) class III or IV congestive heart failure symptoms.
  • Severe regurgitant or stenotic cardiac valvular lesion.
  • Severe left ventricular systolic dysfunction (LVEF ≤ 35 % documented in the last year); if no assessment was performed or documented in the year preceding enrollment, presume normal LVEF.
  • Active systemic infection (diagnosed by a combination of clinical symptoms and laboratory testing, including but not limited to fever, leukocytosis, positive blood cultures, pneumonia, urinary tract infection, or abscess in the preceding 2 months) or chronic infection (e.g., HIV, Hepatitis B or C, Tuberculosis).
  • Protocol-specified rheumatologic, autoimmune or hematologic conditions (e.g., rheumatoid arthritis, systemic lupus erythematosis, polymyalgia rheumatica, or systemic sarcoidosis).
  • Known or suspected diabetes mellitus or documented Hemoglobin A1c (HbA1c) ≥ 6.5; presume normal HbA1c if none documented.
  • Total WBC ≥ 11,000 cells/ul and platelet count ≤ 75,000 cells/ul from a CBC with differential drawn within 7 days prior to enrollment [WBC ≥ 11,000 cells/ul and platelet count ≤ 75,000 cells/ul from a CBC drawn > 7 days prior need to be re-drawn at enrollment].
  • Recipient of any organ transplant.
  • Immunosuppressive or immunomodulatory therapy including any dose of systemic corticosteroids in the preceding 2 months.
  • Chemotherapy in the preceding year.
  • Major surgery in the preceding 2 months.
  • Blood or blood product transfusion in the preceding 2 months.
  • Subjects for whom all forms (stress or pharmacologic) of MPI are contraindicated.
  • Subjects for whom invasive coronary angiography or coronary CT angiography is contraindicated, including IV beta-blocker.
  • Subjects who planned to decline research CCTA or invasive coronary angiography, regardless of MPI result.
  • Subjects with history of atrial fibrillation/flutter or frequent irregular or rapid heart rhythms.
  • Known history of renal insufficiency (serum creatinine ≥ 2.0 mg/dL), or severe allergy to iodinated contrast.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01117506


Locations
United States, California
Long Beach Memorial Hospital
Long Beach, California, United States, 90806
Sutter Roseville Medical Center
Roseville, California, United States, 95661
United States, Colorado
Pikes Peak Cardiology
Boulder, Colorado, United States, 80909
United States, Kansas
Midwest Cardiology Associates
Overland Park, Kansas, United States, 66209
United States, Missouri
St. Luke's Hospital
Kansas City, Missouri, United States, 64111
United States, Pennsylvania
Berks Cardiologists, Ltd
Wyomissing, Pennsylvania, United States, 19610
United States, Virginia
Cardiovascular Associates of Virginia
Midlothian, Virginia, United States, 23114
Sponsors and Collaborators
CardioDx
Cardiovascular Research Foundation, New York
Piedmont Heart Institute, Inc., Atlanta, GA
Investigators
Study Director: May Yau, MS CardioDx
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: CardioDx
ClinicalTrials.gov Identifier: NCT01117506     History of Changes
Other Study ID Numbers: CDX_000007
COMPASS ( Other Identifier: CardioDx )
First Submitted: May 3, 2010
First Posted: May 5, 2010
Last Update Posted: October 19, 2017
Last Verified: October 2017

Keywords provided by CardioDx:
Angina Pectoris
Myocardial Ischemia
Molecular Genetics
Atherosclerosis
Corus CAD
ASGES
Age/Sex/Gene Expression Score
Gene Expression
GES
CAD
CVD
CHD
Precision Medicine
Clinical Validity
Myocardial Perfusion Imaging
Coronary Artery Disease
Chest Pain
Cardiovascular Disease
Coronary Heart Disease
MPI
COMPASS

Additional relevant MeSH terms:
Cardiovascular Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Chest Pain
Angina Pectoris
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms