NewCardio publishes Cardio3KG clinical study for acute cardiac diagnosis

NewCardio (OTC Bulletin Board: NWCI) a cardiac diagnostic technology provider, announced today that a clinical study of the Cardio3KG™ in acute cardiac diagnosis has been published in the August 2010 issue of the peer-reviewed journal, Heart Rhythm, the official journal of the Heart Rhythm Society. The study, entitled "Vectorcardiographic and Electrocardiographic Criteria to Distinguish New and Old Left Bundle Branch Block," was led by Alexei Shvilkin, MD, PhD, Peter Zimetbaum, MD, Kalon Ho, MD, and Mark Josephson, MD, from the Cardiology Division at Beth Israel Deaconess Medical Center and Harvard Clinical Research Institute, Boston, in collaboration with Ihor Gussak MD, PhD, Bosko Bojovic PhD, and Branislav Vajdic, PhD, from NewCardio.

Patients in Emergency Departments (ED) with suspected myocardial infarction (MI), commonly referred to as a heart attack, frequently have a diffuse 12-lead ECG abnormality known as Left Bundle Branch Block (LBBB). Unfortunately, this abnormality makes it difficult or impossible to "read" the ECG for signs of an acute heart attack. Because of this uncertainty, the great majority of LBBB patients are taken directly for invasive interventional procedures. In most such patients, however, the LBBB abnormality is an old and stable finding unrelated to the patient's current symptoms, and the procedures expose the patient to unnecessary risk and discomfort, as well as adding to healthcare costs. Thus, a fast, reliable and inexpensive way to distinguish patients with "old" LBBB from patients with "new" LBBB is needed.

Dr. Shvilkin and colleagues obtained ECG data from 39 patients with new LBBB and 1760 patients with old LBBB, and used NewCardio's Cardio3KG suite of 3D-based ECG analysis algorithms to identify a novel Cardio3KG marker called the QRS-T Loop ratio. This allowed highly accurate discrimination between new and old LBBB (100% sensitive and 96% specific for correctly assigning LBBB tracings to the "new" or "old" category). This important advance is expected to provide a cost-effective solution to a long-standing and notoriously difficult diagnostic dilemma in acute MI diagnosis. Moreover, because the Cardio3KG uses standard 12-lead ECG input, its analytical results are available in minutes and require no change in standard ED practices or special training of the ED staff.

Dr. Shvilkin, the study's Principal Investigator, commented: "We believe these study results have substantial clinical significance. The ability of Cardio3KG to identify old LBBB will help reduce unnecessary invasive procedures and lower the overall cost of medical care. On the other hand, the accurate identification of new LBBB by Cardio3KG will reinforce the need for aggressive management and urgent coronary intervention, and may thereby improve long-term clinical outcomes for acute MI patients."

Dr. Gussak, NewCardio's Chief Medical Officer and a study co-investigator, commented: "The paper makes a major and exciting contribution to acute MI diagnosis. Our clinical studies to date have shown a substantial improvement in sensitivity for diagnosing a heart attack. The latest results show that Cardio3KG accurately identifies new LBBB, adding to the diagnostic power of this solution. We are very fortunate to work with Dr. Shvilkin and his Harvard colleagues on this and other Cardio3KG studies. Their work represents truly innovative and important contributions, and we look forward to many more."