An observational study in Chest Pain, Cardiovascular Diseases and Angina Pectoris, sponsored by CardioDx. Completed at 4 sites in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2019-01-31.
Sponsored by CardioDx · Observational
This is a prospective, multi-center study examining the clinical impact of the Corus CAD (Age/Sex/Gene Expression score - ASGES) assay in approximately 250 evaluable subjects with no history of obstructive coronary artery disease who now present with chest pain or anginal-equivalent symptoms to a primary care physician (PCP) for evaluation.
In symptomatic patients with or without prior cardiac testing, the PCP will initially decide the subject's pretest probability for coronary artery disease (CAD) based on the subject's risk factors and quality of chest pain (typical or atypical), or anginal equivalent (e.g., jaw, arm pain, or unexplained shortness of breath) and consider the results of prior testing, if applicable. The initial questionnaire will capture the PCP's initial clinical impression and decision ('preliminary decision') on how to further evaluate and manage the patient. A Corus CAD (Age/Sex/Gene Expression score - ASGES) assay will be performed at the PCP's office. After the PCP has received the Corus CAD (ASGES) result (approximately 2-3 days later), the PCP will decide on the appropriate evaluation and management of the patient ('final decision') using the Corus CAD (ASGES) result in conjunction with his/her clinical impression and/or other clinical data available. The primary aim of this study is to evaluate whether the Corus CAD (ASGES) test results is associated with a change in the PCPs' diagnostic evaluation and management of patients as compared to their initial testing and treatment decisions.
Since it takes approximately two days for the physician to receive the result of the Corus CAD (ASGES), symptomatic subjects with unstable angina, or suspicion for myocardial infarction will be excluded from the study.
A follow-up phone call and a detailed questionnaire will be performed at 30 + 15 days, from the time of blood draw, to assess the triage decision, such as referral to any subspecialists (cardiologist, gastroenterologist, and pulmonologist), cardiac diagnostic tests performed, cardiac procedures performed, and results of these cardiac tests and procedures.
388 studies on the registry are indexed under Chest Pain; 67 are open to participants now.
This study's enrollment of 251 is below the median of 500 across 167 observational studies indexed under Chest Pain.
Browse Chest Pain studies →CardioDx is the lead sponsor of 13 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
This is a prospective, multi-center study examining the clinical impact of the Corus CAD (Age/Sex/Gene Expression score - ASGES) assay in approximately 250 evaluable subjects with no history of obstructive coronary artery disease who now present with chest pain or anginal-equivalent symptoms to a primary care physician (PCP) for evaluation.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Any individuals with :
Any individuals currently taking:
Subjects are enrolled at multiple participating primary care practices. The main inclusion criterion for enrollment is the occurrence of chest pain (or anginal equivalent) in a patient without known significant coronary artery disease (CAD) or a history of prior myocardial infarction.
Diagnostic Test: Corus CAD
Age/Sex/Gene Expression Score (ASGES)
Change in Clinicians' Treatment Decision After Age/Sex/Gene Expression Score
The primary objective was to assess whether the Age/Sex/Gene Expression Score (ASGES) altered clinicians' evaluations, defined by a change in patient management from preliminary to final decision. The change was prospectively defined as a downgrade or upgrade in intensity of the diagnostic plan based on the following hierarchical categories:(1) no further cardiac testing or treatment, (2) lifestyle changes or medical therapy, (3) stress testing (with or without imaging) or computed tomography/coronary angiography, or (4) invasive coronary angiography. The ASGES algorithm comprises expression values for 23 genes from peripheral blood cells in 6 terms, patient age, and sex. The changes in gene expression are quantified using an algorithm that generates a ASGES ranging from 1 to 40. A score \<=15 indicates a low risk of underlying obstructive coronary disease. The ASGES has a negative predictive value of 96% for ASGES \<=15 in a population referred to myocardial perfusion imaging.
Time frame: pre- and post- gene expression testing results (on average 2-3 days to receive ASGES)
Subjects are enrolled at multiple participating primary care practices from site initiation (Apr-Jun 2012) thru January 2013.
| Milestone | All Subjects With Corus CAD |
|---|---|
| Started | 251 |
| Completed | 249 |
| Not completed | 2 |
| Withdrew: Lost to follow-up | 2 |
The primary objective was to assess whether the Age/Sex/Gene Expression Score (ASGES) altered clinicians' evaluations, defined by a change in patient management from preliminary to final decision. The change was prospectively defined as a downgrade or upgrade in intensity of the diagnostic plan based on the following hierarchical categories:(1) no further cardiac testing or treatment, (2) lifestyle changes or medical therapy, (3) stress testing (with or without imaging) or computed tomography/coronary angiography, or (4) invasive coronary angiography. The ASGES algorithm comprises expression values for 23 genes from peripheral blood cells in 6 terms, patient age, and sex. The changes in gene expression are quantified using an algorithm that generates a ASGES ranging from 1 to 40. A score \<=15 indicates a low risk of underlying obstructive coronary disease. The ASGES has a negative predictive value of 96% for ASGES \<=15 in a population referred to myocardial perfusion imaging.
| number of subjects | No Tests/Treatment | Medical Therapy | Stress Test | Invasive Angiography |
|---|---|---|---|---|
| No Tests/Treatment pre-ASGES, ASGES <=15 (n=40) | 38 | 1 | 1 | 0 |
| NoTests/Treatment pre-ASGES, ASGES >15 (n=43) | 3 | 1 | 39 | 0 |
| Medical Therapy pre-ASGES, ASGES ,=15 (n=33) | 25 | 7 | 1 | 0 |
| Medical Therapy pre-ASGES, ASGES >15 (n=15) | 5 | 2 | 7 | 1 |
| Stress Tes pre-ASGES, ASGES <=15 (N=53) | 45 | 5 | 3 | 0 |
| Stress test pre-ASGES, ASGES >15 (n=65) | 5 | 6 | 53 | 1 |
| Invasive Coronary Angio pre-ASGES, AGES >=15 (n=1) | 1 | 0 | 0 | 0 |
| Invasive Coronary Angio pre-ASGES, ASGES >15 (n=1) | 1 | 0 | 0 | 0 |
Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| All Subjects | — | 0/251 (0%) | 0/251 (0%) |
Sequentially enrolled subjects meeting the inclusion/exclusion criteria and have a resulted CORUS CAD test.
| Age, Categorical(Participants) | All Subjects |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 182 |
| >=65 years | 69 |
| Age, Continuous(years) | All Subjects |
|---|---|
| Mean | 56.2 ± 13 |
| Sex: Female, Male(Participants) | All Subjects |
|---|---|
| Female | 140 |
| Male | 111 |
| Region of Enrollment(participants) | All Subjects |
|---|---|
| United States | 251 |
| Body Mass Index (BMI)(kg/m^2) | All Subjects |
|---|---|
| Mean | 29.7 ± 6.7 |
| Age/Sex/Gene Expression Score(unitless) | All Subjects |
|---|---|
| Mean | 16 ± 10 |
This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
CardioDx