Trial Outcomes & Findings for PCP Use of a Gene Expression Test (Corus CAD or ASGES) in Coronary Artery Disease Diagnosis (NCT NCT01594411)

Last Updated: 2019-01-31

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

251 participants

Primary outcome timeframe

pre- and post- gene expression testing results (on average 2-3 days to receive ASGES)

Results posted on

2019-01-31

Participant Flow

Subjects are enrolled at multiple participating primary care practices from site initiation (Apr-Jun 2012) thru January 2013.

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.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	251
Overall Study COMPLETED	249
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Lost to Follow-up	2

Baseline Characteristics

PCP Use of a Gene Expression Test (Corus CAD or ASGES) in Coronary Artery Disease Diagnosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Subjects n=251 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	182 Participants n=5 Participants
Age, Categorical >=65 years	69 Participants n=5 Participants
Age, Continuous	56.2 years STANDARD_DEVIATION 13 • n=5 Participants
Sex: Female, Male Female	140 Participants n=5 Participants
Sex: Female, Male Male	111 Participants n=5 Participants
Region of Enrollment United States	251 participants n=5 Participants
Body Mass Index (BMI)	29.7 kg/m^2 STANDARD_DEVIATION 6.7 • n=5 Participants
Age/Sex/Gene Expression Score	16 unitless STANDARD_DEVIATION 10 • n=5 Participants

PRIMARY outcome

Timeframe: pre- and post- gene expression testing results (on average 2-3 days to receive ASGES)

Population: The study sites included 9 clinicians at 4 community-based primary care practices who assessed all participants with a valid ASGES.

Outcome measures

Outcome measures
Measure	No Tests/Treatment n=123 Participants Physician decision for no additional tests or cardiac treatment after receiving patients' GES	Medical Therapy n=22 Participants Physician decision for lifestyle changes or medical therapy after receiving patients' GES	Stress Test n=104 Participants Physician decision for stress testing (with or without imaging) or computed tomography/coronary angiography after receiving patients' GES	Invasive Angiography n=2 Participants Physician decision for invasive coronary angiography after receiving patients' GES
Change in Clinicians' Treatment Decision After Age/Sex/Gene Expression Score No Tests/Treatment pre-ASGES, ASGES <=15 (n=40)	38 number of subjects	1 number of subjects	1 number of subjects	0 number of subjects
Change in Clinicians' Treatment Decision After Age/Sex/Gene Expression Score NoTests/Treatment pre-ASGES, ASGES >15 (n=43)	3 number of subjects	1 number of subjects	39 number of subjects	0 number of subjects
Change in Clinicians' Treatment Decision After Age/Sex/Gene Expression Score Medical Therapy pre-ASGES, ASGES ,=15 (n=33)	25 number of subjects	7 number of subjects	1 number of subjects	0 number of subjects
Change in Clinicians' Treatment Decision After Age/Sex/Gene Expression Score Medical Therapy pre-ASGES, ASGES >15 (n=15)	5 number of subjects	2 number of subjects	7 number of subjects	1 number of subjects
Change in Clinicians' Treatment Decision After Age/Sex/Gene Expression Score Stress Tes pre-ASGES, ASGES <=15 (N=53)	45 number of subjects	5 number of subjects	3 number of subjects	0 number of subjects
Change in Clinicians' Treatment Decision After Age/Sex/Gene Expression Score Stress test pre-ASGES, ASGES >15 (n=65)	5 number of subjects	6 number of subjects	53 number of subjects	1 number of subjects
Change in Clinicians' Treatment Decision After Age/Sex/Gene Expression Score Invasive Coronary Angio pre-ASGES, AGES >=15 (n=1)	1 number of subjects	0 number of subjects	0 number of subjects	0 number of subjects
Change in Clinicians' Treatment Decision After Age/Sex/Gene Expression Score Invasive Coronary Angio pre-ASGES, ASGES >15 (n=1)	1 number of subjects	0 number of subjects	0 number of subjects	0 number of subjects

Adverse Events

All Subjects

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

EJ Fernandez, MD, CCRP - Sr. Manager Clinical Affairs

CardioDx, Inc.

Phone: 650-383-3350

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
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Restriction type: OTHER