International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA) Trial
ID Number 16-0178Principal Investigator(s)
Department(s) or Division(s)
The purpose of this study is to learn more about how to help people who have narrowed heart arteries due to the buildup of cholesterol. When a heart artery narrows, some parts of the heart may not receive enough blood to work normally. Doctors refer to this problem as ischemia, and they have two standard ways to treat it.
- One way uses medicines and lifestyle changes to control symptoms (angina or chest pain) and reduce serious events (such as heart attack). Medicines that are routinely used for this include aspirin and cholesterol lowering drugs and beta blockers. Lifestyle changes may include changes to one’s diet, exercising more, and not smoking.
- Another way uses a procedure to open artery narrowings with a balloon and stents and/or heart surgery to bypass the problemed artery. In addition, medicines and lifestyle changes are also prescribed. Stents are small metal mesh tubes that are placed into heart arteries to prop them open. Coronary artery bypass is a surgical operation to insert a blood vessel from the patient's leg or chest so blood can get past the blocked area in the heart artery. Doctors and patients make the choice between stents and bypass surgery based on which procedure is thought to provide the better result.
Both treatments #1 and #2 are used by doctors around the world and are not experimental. The goal is to see which one saves more lives and prevents more heart attacks in people who are at risk of having a heart attack and a shortened life span because of narrowed arteries and ischemia. The study will do this by comparing the two. The researchers do not know which group, if either, will do better.
If a patient volunteers to join this study, the study team will randomly assign them to receive medicines and lifestyle counseling alone, or to do a procedure called an angiogram to determine if stents or bypass surgery is needed, in addition to the medicines and lifestyle counseling.
The study team will regularly collect routine medical information, as well as information about the cost of the volunteer's care. They will ask standard questions about the patient's quality of life so that they can understand the personal, medical, and economic effects of these two treatments.
Patients may qualify to take part in this research study if their doctor suspects that they have ischemia.
Funds for conducting this study are provided by National Heart, Lung and Blood Institute (NHLBI).
Recruiting Patients: Yes