CardioDx and thought leaders in cardiology collaborated to conduct a prospective, multi-center clinical study in the field of coronary artery disease (CAD) called PREDICT (Personalized Risk Evaluation and Diagnosis In the Coronary Tree).
The PREDICT study goals were to develop and validate a gene expression test (Corus™ CAD) that assesses the likelihood of obstructive* CAD in patients with stable chest pain.
Atherosclerotic coronary artery disease (CAD) is the most common cause of morbidity and mortality worldwide. CAD is caused by a complex interaction of genetic and environmental factors. Assessing the presence of obstructive CAD in symptomatic chest pain patients well in advance of potential myocardial infarction or death is critically important. However, despite advances in current methods (e.g. imaging technologies), non-invasive assessment of obstructive CAD continues to be challenging. The complexity of CAD assessment lies not only in the variation of presenting symptoms, but also in the patient’s unique characteristics.
There are well-known biologically based theories of atherogenesis and atherosclerotic progression in the human vasculature. The PREDICT study aimed to identify the specific genomic and biological markers in peripheral blood that reflect the likelihood of obstructive CAD in stable chest pain patients, and the Corus CAD test performance was independently demonstrated in a clinical validation study.
PREDICT was a prospective, multi-center, blinded† study that enrolled 1,795 non-diabetic patients in more than 40 clinical sites in the United States to develop and validate Corus CAD. PREDICT:
- Enrolled patients with chest pain undergoing invasive coronary angiography who met study inclusion criteria
- Employed consistent and reliable sample collection and processing techniques
- Collected extensive clinical data that was monitored and source-verified for accurate clinical phenotyping and analysis
- Performed quantitative coronary angiography (QCA) on invasive angiograms using a blinded core laboratory to determine an unbiased reference standard for the primary endpoint of luminal diameter stenosis due to coronary artery disease
- Compared gene expression between groups of cases with ≥50% diameter stenosis and controls with <50% diameter stenosis as determined by QCA
For more information about the PREDICT study, see clinicaltrials.gov.
* Obstructive CAD is defined as at least one atherosclerotic plaque causing ≥50% luminal diameter stenosis in a major coronary artery (≥1.5 mm lumen diameter) as determined by invasive quantitative coronary angiography (QCA).
† Data was analyzed in a blinded fashion.
- PREDICT trial. Clinical trial summary found at: www.clinicaltrials.gov, NCT00500617.
