Mayo Clinic Seeks Patients with Moderate to Severe Angina for Clinical Trial

Friday, April 08, 2005

SCOTTSDALE, Ariz. — Mayo Clinic seeks patient volunteers over age 18 with moderate to severe angina to participate in a clinical trial. The research study seeks to determine if gene therapy is effective for the treatment of severe angina in patients who are not candidates for surgery or stents.

Gene therapy is a new medical procedure in which human DNA is introduced into cells to encourage specific protein production. This clinical trial is evaluating the safety and efficacy of administering a one-time injection of the protein VEGF2 (Vascular Endothelial Growth Factor 2) for the reduction of angina. VEGF2 is a naturally occurring protein (DNA) in humans and is a factor involved in forming new blood vessels. VEGF2 is used in this study to create new blood vessels to increase blood flow to the heart, decreasing episodes of chest pain (angina), and increasing exercise tolerance.

Angina results from coronary artery disease, a condition characterized by a narrowing of the arteries and blood flow reduction, and manifests as chest pain due to lack of adequate blood supply to the heart muscle. Moderate to severe (Class III and IV) angina are the most severe forms of this condition, affecting more than one-third of the 400,000 newly diagnosed cases in the U.S. each year. Approximately 6.8 million coronary patients in the U.S. have angina. Of these patients with angina, approximately 150,000 to 250,000 patients with moderate to severe angina annually cannot be successfully treated with conventional therapies.

Patients will be asked to complete a physical exam, including but not limited to blood and urine samples, chest X-ray, ECG, nuclear stress tests and echocardiogram. The study drug, VEGF2, is injected into the heart by catheters inserted into the groin (similar to cardiac catheterization) and a hospital stay is required one to two days after treatment. Clinical testing and examination will be performed the first three months. The patients will be followed for 15 years (no further testing during this time is required).

Mayo Clinic is one of only a handful of medical centers nationwide to perform this procedure as part of a clinical trial for the treatment of severe cardiovascular disease.

Those interested in participating are encouraged to call Debbie Unger, R.N., Mayo Clinic, at 480-342-5882.

Mayo Clinic is a private group practice of medicine dedicated to providing diagnosis and treatment of patient illnesses through a systematic focus on individual patient needs. As a leading academic medical center in the Southwest, Mayo Clinic focuses on providing specialty and surgical care in more than 65 disciplines at its outpatient facility in north Scottsdale and at Mayo Clinic Hospital. The 208-licensed bed hospital is located at 56th Street and Mayo Boulevard (north of Bell Road) in northeast Phoenix, and provides inpatient care to support the medical and surgical specialties of the clinic, which is located at 134th Street and Shea Boulevard in Scottsdale.

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