Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Coronary Obstruction Detection by Molecular Personalized Gene Expression (COMPASS)

This study has been completed.
Sponsor:
Collaborators:
Cardiovascular Research Foundation, New York
Piedmont Heart Institute, Inc., Atlanta, GA
Information provided by (Responsible Party):
CardioDx
ClinicalTrials.gov Identifier:
NCT01117506
First received: May 3, 2010
Last updated: February 7, 2013
Last verified: February 2013

May 3, 2010
February 7, 2013
April 2010
May 2011   (final data collection date for primary outcome measure)
To determine the accuracy of Corus CAD 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 ] [ Designated as safety issue: No ]
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.
To determine the accuracy of Corus CAD 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 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01117506 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Coronary Obstruction Detection by Molecular Personalized Gene Expression
Coronary Obstruction Detection by Molecular Personalized Gene Expression

To validate the use of Corus™ CAD 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) 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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

RNA PAXgene

Probability Sample

The study will enroll a patient population that presents with stable chest pain syndrome or anginal equivalent and referred for stress myocardial profusion imaging.

Coronary Artery Disease
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
600
May 2012
May 2011   (final data collection date for primary outcome measure)

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.
Both
35 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01117506
CDX 000007
No
CardioDx
CardioDx
  • Cardiovascular Research Foundation, New York
  • Piedmont Heart Institute, Inc., Atlanta, GA
Study Director: May Yau, MS CardioDx
CardioDx
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP