Research Study for Patients with Heart Disease

The University of Chicago and Dr. Sandeep Nathan are conducting a research study for patients with heart disease. Patients in this study have a problem with a narrowing in one or more of their coronary (heart) arteries (blood vessels which supply blood to the muscle of the heart). This narrowing can stop the heart muscle from receiving enough blood rich in oxygen, which may cause patients to have chest pain (angina) and/or shortness of breath during exercise or even at rest. One commonly used treatment for this problem is to insert a tube with a balloon on the end of it into the part of the artery that is narrow. The balloon is then inflated to stretch the narrowed part back to its original size. This treatment is called balloon angioplasty. Although balloon angioplasty is successful in more than 90 percent of cases, in at least one-third of patients the narrowing comes back within six months after the angioplasty is performed. Other research studies have shown that the chance of re-narrowing can be reduced to a certain extent by implanting a small metal tubular device known as a stent. Stent implantation is often performed in addition to balloon angioplasty.

The purpose of this study is to evaluate if an experimental stent using a new chemical coating is safe and effective in reducing the re-narrowing in coronary arteries over time. The word "experimental" means the stent is still being tested and is not approved by the FDA (Food and Drug Administration).

You will be in this study for about five years. Some of the procedures that will be done during this study are: the stent implant procedure, angiogram (x-ray of the arteries), physical exams, blood testing, and electrocardiograms (ECG). After the implant procedure, you will see a study doctor at 30 days and nine months after the procedure. If the size of the opening in your artery requires a larger sized stent, you will be asked to see your doctor at an additional visit at eight months. During this eighth month visit, you will have an angiogram too. Lastly, we will contact you by phone to ask about your health at six months, 12 months, 18 months, and every year (up to five years after the procedure).

You will receive payment for your participation in the eighth month and ninth month visits.

Benefits

You may not receive any direct medical benefit from participating in this study. Your participation may provide information that may benefit other patients with heart disease in the future.

Participation Details

• Must be at least 18 years of age
• Must not be pregnant
• Must meet study medical criteria as evaluated by Dr. Nathan

Study Director: Dr. Sandeep Nathan
Department: Cardiology

For more information contact:
Bridget Galetti
bgaletti@medicine.bsd.uchicago.edu
(773) 702-0347

IRB# 16573B