New Phase I Trial to Examine Non-Invasive Treatment for Chest Pain
The most common symptom of coronary artery disease is chest pain, medically known as angina pectoris. Angina affects more than ten million people in the United States, according to the American Heart Association. Despite the use of traditional therapies, some patients continue to experience pain. UC San Diego Health System is enrolling patients in a two-year study to examine the safety of a new non-invasive treatment called the cardio shock wave procedure.
Angina is caused when blood flow to an area of the heart is decreased, impairing the delivery of oxygen and vital nutrients to the cardiac tissue cells. The heart then uses a less efficient form of fuel, which produces lactic acid buildup in the muscle.
Medications typically used to treat angina include beta-blockers, nitrates, calcium channel blockers and ranolazine. Patients may also be given an anti-clotting medication. Those who do not respond to medication, or who have more serious or worsening angina, are evaluated for a surgical procedure including angioplasty, stenting, or coronary artery bypass grafting (CABG).
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 caused by insufficient blood flow to the heart. The technology is similar to Extracorporeal Shock Wave Lithotripsy (ESWL) that is used in the treatment of kidney stones, but at a lower strength. The shock wave schedule consists of three 20-minute sessions per week over nine weeks.
“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 Anthondy DeMaria MD, cardiologist and principal investigator of the study. He is also editor-in-chief of the Journal of the American College of Cardiology.
The Phase I trial, sponsored by Medispec Ltd, is recruiting a maximum of 15 US patients who will be evaluated at two and four-month intervals after the last treatment. These evaluations will include a physical exam, treadmill tests, blood work, drug-induced stress test, and an interview to discuss any adverse events or complications.