BG Medicine publishes BioImage trial design

July 13, 2010 by MassDevice staff

BG Medicine's move to "bring the study to the people" using a new patient recruiting model is published in the American Heart Journal.

The American Heart Journal published BG Medicine Inc.'s method to "bring the study to the people" by making it more convenient for patients to enroll in its BioImage clinical trial.

The Waltham, Mass.-based diagnostics firm is a member of the High-Risk Plaque Initiative, an industry coalition aiming to develop early detection of patients at risk for serious cardiac conditions caused by blood vessel obstructions.

The group's 7,687-patient BioImage study enrolled patients via a new recruiting model. Rather than developing its patient base from academic research centers — thereby limiting the potential subject pool to patients with access to those centers — the study made it "logistically convenient" for patients to enroll, according to the HRP's website. BG Medicine, Merck & Co. (NYSE:MRK), AstraZeneca (NYSE:AZN), Philips (NYSE:PHG), Takeda (TYO:4502) and Abbott (NYSE:ABT) are the intiative's founding companies.

To obtain a representative sample of the U.S. population, BG partnered with healthcare provider Humana Inc. (NYSE:HUM) to tap its customers in Chicago and South Florida for the study, according to a press release. The recruiters, using Humana's patient data, coded the data using demographic information from the U.S. Census to mimic the makeup of the U.S. population. More than 24,000 Humana members were surveyed by telephone or mail, according to the American Heart Journal.

Of the roughly 7,700 patients selected, 865 only took a phone survey. About 700 others underwent standard risk assessment using the Framingham Heart Study protocol and the remaining 6,100 were given a "comprehensive risk assessment" in a mobile facility. The assessment included evaluation of cardiovascular risk factors, screening for asymptomatic atherosclerosis via CT scan and ultrasound checks for carotid plaque and abdominal aortic aneurysms.

Any participants with at least one abnormal test result was given MRI scans for carotid and aortic plaques, CT angiography for stenosis and non-calcified plaques and 18F-fluorodeoxyglucose positron emission tomography/CT for carotid and aortic plaque inflammation, according to the journal. Biological samples were kept for future biomarker discovery studies. The participants will be tracked until 600 "major atherothrombotic events" have occurred.

The HRP Initiative wants other researchers to get in on the act and is seeking research proposals for studies using the samples and imaging generated by the study.