Cambridge Heart has enrolled its first patients into the MTWA-CAD (Evaluation of Microvolt T-Wave Alternans Testing for the Detection of Active Ischemia in Patients with Known or Suspected Coronary Artery Disease) trial that will evaluate whether microvolt T-wave alternans (MTWA) technology can augment current testing methods that depict ischemia, such as cardiac stress testing.
The trial, which aims to enroll 200 patients and to be completed in 2011, hopes to show that MTWA has the potential to diagnose and assess hidden ischemia in patients with underlying CAD, and become an add-on to cardiac stress tests, the Tewksbury, Mass.-based company said.
"Today, we use MTWA to determine if a patient is at increased risk for potentially fatal arrhythmias, but the test may also have value in detecting underlying coronary artery disease," said Edward Kosinski, MD, a cardiologist at Cardiology Physicians in Bridgeport, Conn., and the medical director of Connecticut Clinical Research, where the first patients have been enrolled. "This study will help us to determine if MTWA can detect blood flow problems as well as electrical problems in the heart."
Last week, the Centers for Medicare & Medicaid Services removed restrictions that previously did not fully cover MTWA tests performed during the same visit as a cardiac stress test. Starting July 1, this will be fully reimbursable.