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| ID | Type | Description | Link |
|---|---|---|---|
| IMPACT-PCP | Other Identifier | CardioDx |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All subjects | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Corus CAD | Diagnostic Test | Age/Sex/Gene Expression Score (ASGES) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | pre- and post- gene expression testing results (on average 2-3 days to receive ASGES) |
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Inclusion Criteria:
Exclusion Criteria:
History of myocardial infarction
Current Myocardial infarction (MI) or acute coronary syndrome.
Current New York Heart Association (NYHA) class III or IV congestive heart failure symptoms.
Any previous coronary revascularization.
Any individuals with :
Any individuals currently taking:
Any Major Surgery within 2 months
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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.
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| Name | Affiliation | Role |
|---|---|---|
| May Yau, MS | CardioDx | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| John's Creek Primary Care | Suwanee | Georgia | 30024 | United States | ||
| The Lipid Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24610188 | Result | Herman L, Froelich J, Kanelos D, St Amant R, Yau M, Rhees B, Monane M, McPherson J. Utility of a genomic-based, personalized medicine test in patients presenting with symptoms suggesting coronary artery disease. J Am Board Fam Med. 2014 Mar-Apr;27(2):258-67. doi: 10.3122/jabfm.2014.02.130155. | |
| 25828395 | Derived |
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327 screened, 275 met inclusion/exclusion. Subjects were excluded from the analysis set if no Corus CAD test could be resulted (7) or if additional information was available and used in making post treatment decisions (3) or did not inclusion/exclusion (discovered after research blood sample draw). Analysis set was 251.
Subjects are enrolled at multiple participating primary care practices from site initiation (Apr-Jun 2012) thru January 2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Subjects With Corus CAD | Subjects are enrolled at multiple participating primary care practices. The main inclusion criterion for enrollment and being tested with Corus CAD is the occurrence of chest pain (or anginal equivalent) in a patient without known significant CAD or a history of prior myocardial infarction. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Sequentially enrolled subjects meeting the inclusion/exclusion criteria and have a resulted CORUS CAD test.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Subjects | 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 CAD or a history of prior myocardial infarction. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The study sites included 9 clinicians at 4 community-based primary care practices who assessed all participants with a valid ASGES. | Posted | Number | number of subjects | pre- and post- gene expression testing results (on average 2-3 days to receive ASGES) |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Subjects | 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 CAD or a history of prior myocardial infarction. |
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Prospective design may have influenced the diagnostic strategy; but historical controls had a similar diagnostic strategy.
Possible Selection bias; we believe these pts are typical of each practice. Appropriateness of care not evaluated
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| EJ Fernandez, MD, CCRP - Sr. Manager Clinical Affairs | CardioDx, Inc. | 650-383-3350 | jkuo@cardiodx.com |
Not provided
| ID | Term |
|---|---|
| D002637 | Chest Pain |
| D002318 | Cardiovascular Diseases |
| D000787 | Angina Pectoris |
| D003324 | Coronary Artery Disease |
| D003327 | Coronary Disease |
| D014095 | Tooth, Impacted |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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One 2.5 mL PAXgene (PreAnalytiXTM) (for RNA preservation) tube will be filled with approximately 7.5 ml of blood and sent to CardioDx, Inc. for analysis.
| Baton Rouge |
| Louisiana |
| 70809 |
| United States |
| Carolina Family Healthcare | Charlotte | North Carolina | 28277 | United States |
| Family Care Clinic | Bonham | Texas | 75418 | United States |
| Ladapo JA, Herman L, Weiner BH, Rhees B, Castle L, Monane M, McPherson JA. Use of a blood test incorporating age, sex, and gene expression influences medical decision-making in the evaluation of women presenting with symptoms suggestive of obstructive coronary artery disease: summary results from two ambulatory care studies in primary care. Menopause. 2015 Nov;22(11):1224-30. doi: 10.1097/GME.0000000000000443. |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| Age/Sex/Gene Expression Score | The ASGES algorithm comprises expression values for 23 genes from peripheral blood cells in 6 terms, patient age, and sex. There are both sex-specific and common algorithm terms with sex-specific weights. The changes in gene expression are quantified using an algorithm that generates a ASGES ranging from 1 to 40. A score less than or equal to 5 indicates a low risk of underlying obstructive coronary disease.The ASGES has been shown to have a negative predictive value of 96% for ASGES less than or equal to 15 in a population referred to MPI. | Mean | Standard Deviation | unitless |
|
| ID | Title | Description |
|---|---|---|
| OG000 | No Tests/Treatment | Physician decision for no additional tests or cardiac treatment after receiving patients' GES |
| OG001 | Medical Therapy | Physician decision for lifestyle changes or medical therapy after receiving patients' GES |
| OG002 | Stress Test | Physician decision for stress testing (with or without imaging) or computed tomography/coronary angiography after receiving patients' GES |
| OG003 | Invasive Angiography | Physician decision for invasive coronary angiography after receiving patients' GES |
|
|
|
| 0 |
| 251 |
| 0 |
| 251 |
CardioDx will provide a copy of the proposed publication to Collaborator for prior review for a thirty (30)-day period, during which period any Collaborator personnel listed as authors may either (a) elect to opt out from being listed as an author, or (b) suggest modifications to the proposed publication, and if they do not elect either (a) or (b) within that period, they will be deemed to have consented to publication as an author.
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D014652 | Vascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |