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Coronary Artery DiseaseCOMPASSNCT01117506

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

An observational study of Coronary Artery Disease and Chest Pain, run by CardioDx at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 35 to 90 years
What is being tested?
Corus CAD (ASGES)
How many people
581 participants
Where
7 sitesUnited States
Study dates
Apr 2010to May 2012
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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).
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  • 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.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • Pikes Peak Cardiology

    Boulder, Colorado, 80909

  • St. Luke's Hospital

    Kansas City, Missouri, 64111

  • Long Beach Memorial Hospital

    Long Beach, California, 90806

  • Cardiovascular Associates of Virginia

    Midlothian, Virginia, 23114

  • Midwest Cardiology Associates

    Overland Park, Kansas, 66209

  • Sutter Roseville Medical Center

    Roseville, California, 95661

  • Berks Cardiologists, Ltd

    Wyomissing, Pennsylvania, 19610

Other trials in United States

About this study

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.

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.

Read the 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.

Being tested
Corus CAD (ASGES)
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
Medical subject headings
Coronary Artery Disease, Chest Pain, Cardiovascular Diseases, Coronary Disease, Angina Pectoris, Myocardial Ischemia, Atherosclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Corus CAD (ASGES)Diagnostic test

    Age/Sex/Gene Expression Score - ASGES

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 45 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 May 2010 (estimated)
  2. Study startApr 2010
  3. Primary completionMay 2011
  4. Study completionMay 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
581 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01117506
Sponsor's protocol ID
CDX_000007
Other IDs
COMPASS
Acronym
COMPASS
Status last verified
Jan 2019
First submitted
3 May 2010
Last updated
31 Jan 2019
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 23418288

  • 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.

    PubMed 24529158

  • 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.

    PubMed 25119856

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease and Chest Pain, run by CardioDx at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01117506, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2019; AzTrials last refreshed its copy on 26 Oct 2026.

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