Comparing medical and invasive approaches to treating ischemia

HS 2013-9775
Mayil Krishnam, MD
UC Irvine Medical Center

The ischemia trial will compare two types of treatments for patients with moderate to severe narrowing of the heart arteries due to a build-up of cholesterol. When a heart artery narrows, some part of the heart may not receive enough blood to work normally. Doctors refer to this problem as ischemia and they have to standard ways to treat it:

  • Conservative treatment or optimal medical therapy —– uses medicines and lifestyle changes to control systems (angina or chest pain) and reduce serious events (such as heart attack).
  • Invasive treatment — uses a procedure to open narrowing artery and/or heart surgery to bypass the problem artery. Stents are small metal mesh tubes that are placed into heart arteries to prop them open. Bypass is a surgical operation to insert a blood vessel from your leg or chest to go around 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 are used by doctors around the world and are not experimental. It is not known whether using stents or bypass surgery is better than using modern medicine and lifestyle changes alone for saving lives and preventing heart attacks. The research study will compare these two standard treatments (invasive versus conservative) to determine which is the better and safer choice.

In order to participate, subjects should be 21 years of age or older and have a qualifying positive stress test.

The study may involve as much as a total of 2 hours for the screening and enrollment, up to randomization. After randomization, there will be follow-up visits lasting about 5- to 10- minutes each, and may include regular medical care visits with the attending physician or by phone.

There may or may not be a benefit from participation in this study. Study participants may benefit by receiving the medications and lifestyle counseling that are proven to improve outcomes in patients, as well as the involvement of an additional team following the participants’ health status. Participants may receive some medications and stents free of cost, as available.

The ischemia trial results should provide evidence-based data to support management of patients with suspected stable ischemic heart disease (SIHD).

As a study participant, you may be compensated up to a total of $425 upon completion of study procedures and study-related visits.

Eduardo Hernandez-Rangel, MD