(PhysOrg.com) -- UC San Diego Health System is enrolling a small group of patients in a two-year study to examine the safety of a non-invasive cardiac shock wave procedure for patients with chest pain caused by insufficient blood flow to the heart.
Angina pectoris is a debilitating form of pain that affects more than ten million people in the U.S., according to the American Heart Association. Traditional angina treatments include drug therapy, angioplasty and coronary artery bypass graft surgery. Despite these therapies, many patients continue to experience the squeezing pain or pressure of continual angina pectoris.
Cardiac shock wave technology sends low-intensity energy to specific areas of the heart to stimulate the growth of new blood vessels and relieve pain. It uses technology similar to, but of lower strength than Extracorporeal Shock Wave Lithotripsy (ESWL) that is used in the treatment of kidney stones.
“These acoustic shock waves are not dissolving plaque in the same way that lithotripsy breaks up a stone,” said Anthony DeMaria, MD, cardiologist and principal investigator of the clinical trial at UC San Diego Medical Center. “Instead, these waves energize the heart tissue to release substances which, in turn, stimulate the formation of new blood vessels in the heart.”
The shock wave schedule consists of three 20-minute sessions per week over nine weeks. Patients who participate in this study will be evaluated at two and four-month intervals after the last treatment. Evaluations include a physical exam, treadmill tests, blood work, a drug induced stress/rest test, and a discussion of any adverse events or complications.
“This potential therapeutic approach is an alternative for patients who continue to have chest pain from angina, even though they take medicine, and are not candidates for a stent or bypass operation,” said DeMaria, associate dean for Outreach and Development for Health Sciences at UC San Diego and editor-in-chief of the Journal of the American College of Cardiology.
A maximum of 15 U.S. patients will be evaluated in this multicenter Phase I trial sponsored by Medispec Ltd., to assess the safety of Cardiospec™ Extracorporeal Shockwave Myocardial Revascularization (ESMR).