CardioDx has announced participation in the PROMISE (Prospective, multicentre imaging study for evaluation of chest pain) study, the first large randomised trial using clinical outcomes to compare alternative diagnostic strategies for assessment of patients with new stable symptoms suggestive of coronary artery disease (CAD).
Sponsored by Duke University in collaboration with the National Heart Lung and Blood Institute (NHLBI), PROMISE will test comparative effectiveness of anatomical versus functional non-invasive diagnostic tests for the assessment of stable symptomatic patients with possible CAD.
Patients with suspected CAD are randomised in equal proportions to receive an initial anatomic imaging strategy using coronary computed tomography angiography (64-slice or greater) versus a functional testing strategy using a site-chosen stress test, including exercise ECG, stress echocardiography, or myocardial perfusion imaging (MPI). The study is expected to enrol 10,000 patients already referred for a non-emergent, non-invasive diagnostic test for CAD at approximately 200 sites in North America.
“As many as five million patients with chest pain undergo non-invasive tests each year to determine if the cause is coronary artery disease, but these tests are not perfect. The PROMISE study will compare anatomic and functional types of tests to discern which might be better at guiding the treatment of patients with suspected heart disease,” said PROMISE principal investigator Pamela S Douglas, Ursula Geller professor for Research in Cardiovascular Diseases at Duke University, director of the Duke Clinical Research Imaging Program and senior fellow in Clinical Health Policy, Duke Center for Clinical Health Policy Research.
As part of the trial, a genomic archive of samples is being obtained, including genetic material (DNA), genomic material (RNA) and plasma. CardioDx will purify and isolate DNA and RNA using proprietary methods. In addition, the company’s blood-based gene expression test, Corus CAD, will be used to evaluate blood samples from an estimated 2,500 to 3,000 non-diabetic patients enrolled in the trial, with the goal of evaluating the ability of the test to predict major clinical cardiovascular events. William Kraus, director of Clinical Research at the Duke Center for Living, is leading the collaboration with CardioDx.
“We are thrilled to participate in the landmark PROMISE trial in collaboration with Duke University that will allow us to evaluate the use of Corus CAD as an aid in the prognosis of clinical events. This study will allow us to build on the results of the Corus CAD test as an aid in the assessment of CAD, as demonstrated in the PREDICT and COMPASS validation studies,” said David Levison, president and CEO of CardioDx. “The findings of PROMISE also will help us determine the potential for developing a new test specifically focused on prognosis for CAD patients, which could involve the use of next-generation sequencing technologies to identify expression of genes predictive of future events.”
The PROMISE trial will follow patients for up to four years or until the study ends, with a primary endpoint of major adverse cardiac events and secondary endpoints related to procedural costs and safety. The first patient was enrolled in the study in July 2010.