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

NCT01117506 | Completed

• 2 other identifiers: CDX_000007COMPASS
• Study Type: observational
• Target: 581
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Coronary Artery Disease; Chest Pain; Cardiovascular Diseases; Coronary Heart Disease; Angina Pectoris; CAD; CVD; CHD

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  Up to 45 days

Interventions

Corus CAD (ASGES) DIAGNOSTIC_TEST

Age/Sex/Gene Expression Score - ASGES

Eligibility Criteria

• Age: 35 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CardioDx: lead
• Cardiovascular Research Foundation, New York: collaborator
• Piedmont Heart Institute, Inc., Atlanta, GA: collaborator

Study Sites (7)

Long Beach Memorial Hospital

Long Beach, California, 90806, United States

Location

Sutter Roseville Medical Center

Roseville, California, 95661, United States

Location

Pikes Peak Cardiology

Boulder, Colorado, 80909, United States

Location

Midwest Cardiology Associates

Overland Park, Kansas, 66209, United States

Location

St. Luke's Hospital

Kansas City, Missouri, 64111, United States

Location

Berks Cardiologists, Ltd

Wyomissing, Pennsylvania, 19610, United States

Location

Cardiovascular Associates of Virginia

Midlothian, Virginia, 23114, United States

Location

Related Publications (3)

• Thomas GS, Voros S, McPherson JA, Lansky AJ, Winn ME, Bateman TM, Elashoff MR, Lieu HD, Johnson AM, Daniels SE, Ladapo JA, Phelps CE, Douglas PS, Rosenberg S. A blood-based gene expression test for obstructive coronary artery disease tested in symptomatic nondiabetic patients referred for myocardial perfusion imaging the COMPASS study. Circ Cardiovasc Genet. 2013 Apr;6(2):154-62. doi: 10.1161/CIRCGENETICS.112.964015. Epub 2013 Feb 15.

  PMID: 23418288 RESULT

• Voros S, Elashoff MR, Wingrove JA, Budoff MJ, Thomas GS, Rosenberg S. A peripheral blood gene expression score is associated with atherosclerotic Plaque Burden and Stenosis by cardiovascular CT-angiography: results from the PREDICT and COMPASS studies. Atherosclerosis. 2014 Mar;233(1):284-90. doi: 10.1016/j.atherosclerosis.2013.12.045. Epub 2014 Jan 20.

  PMID: 24529158 RESULT

• Daniels SE, Beineke P, Rhees B, McPherson JA, Kraus WE, Thomas GS, Rosenberg S. Biological and analytical stability of a peripheral blood gene expression score for obstructive coronary artery disease in the PREDICT and COMPASS studies. J Cardiovasc Transl Res. 2014 Oct;7(7):615-22. doi: 10.1007/s12265-014-9583-3. Epub 2014 Aug 14.

  PMID: 25119856 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

RNA PAXgene

MeSH Terms

Conditions

Coronary Artery Disease; Chest Pain; Cardiovascular Diseases; Coronary Disease; Angina Pectoris; Myocardial Ischemia; Atherosclerosis

Condition Hierarchy (Ancestors)

Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• May Yau, MS

  CardioDx

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2010
• First Posted: May 5, 2010
• Study Start: April 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2012
• Last Updated: January 31, 2019

Record last verified: 2019-01

Locations

US (7)