Clinical Research

BEACON

It is estimated that 11.2 million patients will come to an Emergency Department for the evaluation of chest pain during 2008 in the United States. Two percent of chest pain patients are quickly identified as STEMI from a standard 12-lead; the remaining 98% undergo a battery of tests. The current standard of an initial 12-lead ECG and biomarker measurement still miss or delay treatment for a substantial number of patients who, in fact, have an acute coronary syndrome.

The BEACON Registry provides clinicians and institutions with a unique opportunity to demonstrate how new ECG, biomarker, imaging technologies as well as improved care processes may be effectively applied to improve patient time to diagnosis, patient time to treatment, patient survival and overall economics.

BEACON is a longitudinal, quality-improvement registry, providing quarterly feedback on all CMS parameters to participating institutions; it will be the first major chest pain registry to have outcomes data. Heartscape has committed funding to enroll 70,000 patients, at 30 hospitals, through 2012. Additional information is available at www.beaconregistry.com.

OCCULT MI

The increased sensitivity achieved through the increased spatial resolution of PRIME ECG® compared to the standard 12-lead ECG is well published. The effect of PRIME ECG® on the processes of care is less well established.

OCCULT MI is a multicenter, clinical trial conducted at 12 hospital EDs. Recognizing that the optimal treatment of AMI depends on rapid time to reperfusion of the infarct-related artery, the primary objective of this study is to measure door-to-sheath-time (DTST) in patients with STEMI on standard 12-lead ECG compared with DTST in patients with STEMI on PRIME ECG® but not on standard ECG (PRIME-only STEMI). The anticipated time delay in door-to-sheath time for PRIME-only STEMIs will be a proxy for the treatment delay that could be eliminated, if the PRIME ECG® system was used routinely in chest pain assessment.

The secondary end point of the trial is to examine the incidence of all ischemia diagnoses on PRIME ECG® in subjects with non-diagnostic 12-lead ECGs, and the sensitivity and specificity of such findings for ACS diagnosis. Once again, the anticipated improvement in sensitivity with comparable specificity represents a measure of the potential for enhanced triage and therapy decisions in these subjects, if the PRIME ECG® system was used routinely in chest pain assessment.

After enrolling 1834 subjects into OCCULT MI, patient enrollment was closed in May 2008. Study results will be presented in an upcoming scientific forum and published in a peer-reviewed journal. For additional details on study design see page 1069 of Early Detection and Diagnosis of Acute Myocardial Infarction: The Potential for Improved Care with Next-Generation, User-Friendly Electrocardiographic Body Surface, Cedric Lefebvre, MD, James Hoekstra, MD, The American Journal of Emergency Medicine, 2007 Nov. 25(9).