Research Trials in the Center for Coronary Disease

EXCEL: Evaluation of XIENCE PRIME™ or XIENCE V® versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization

The purpose of this research study is to see if the study devices are safe and effective treatment for the narrowing of the left main heart artery when compared to Coronary Artery Bypass (CABG) surgery.  The XIENCE V stent is approved for use by the United States Food and Drug Administration (FDA) for the treatment of narrowed coronary arteries (blood vessels in the heart).  However, the use of the XIENCE V stent for the treatment of left main disease is considered experimental in this trial. The XIENCE PRIME stent is not currently available for use in this Trial in the United States as it has not been approved for use by the FDA (is available commercially outside the U.S. for treatment of narrowing of several heart arteries).

In this trial, some patients will be treated with one of the study devices and others will have CABG surgery. The treatment will be assigned randomly, and either treatment is equally likely to be selected (50:50 odds for either treatment, like the flip of a coin).

The EXCEL Randomized Clinical Trial will enroll about 2600 subjects at approximately 165 sites worldwide. The randomized trial is part of a larger study with a planned enrollment of approximately 3600 patients.  Patients who do not meet eligibility criteria for enrolling in the Randomized Clinical Trial may be qualified to participate in a Registry.

This trial will continue up to 5 years but may continue up to 10 years. Individual participation is expected to last at least 3 years.

class="normalgrey"For more information, interested participants and clinicians may contact Eileen McDonald at (312) 695-3410 or e-mail emcdona1@nmh.org 

4D Magnetic Resonance Imaging (MRI) Cardiovascular Flow Imaging

This study is looking for patients with known heart disease. The purpose of this study is to use new MRI technology, known as 4D MRI, to help researchers develop clearer and more accurate pictures of the heart.  MRI is a widely used non-invasive clinical test that uses magnetic fields and radio waves rather than x-rays to provide detailed pictures of internal organs, including the heart.  When a doctor looks at these images, he/she can gather information that can be used to diagnose certain diseases of the body.

Approximately 500 subjects will be enrolled in the study at Northwestern.

CANTOS (ACZ885M-2301)

The ACZ 885 study is looking for patients who have had a heart attack at least 30 days ago as well as ongoing increased inflammation in their blood vessels.

The purpose of this study is to find out if canakinumab (“study drug”) reduces inflammation and is both safe and beneficial in reducing future cardiovascular events (such as heart attacks and strokes) in patients who have had a heart attack and ongoing increased inflammation in their blood vessels. This study will also test whether or not the study drug reduces the development of Type 2 diabetes in subjects who have had abnormal blood sugar levels after their heart attack. 

Both cardiovascular disease and Type 2 diabetes (adult-onset diabetes) involve inflammation.  In cardiovascular disease, interleukin-1 beta (IL-1ß) in the bloodstream and tissues may promote further cardiovascular disease events through ongoing inflammation of the blood vessel walls. In patients with Type 2 diabetes, there is a resistance to the effects of insulin, (a hormone that regulates the movement of sugar into the body’s cells) or the body doesn't produce enough insulin to maintain a normal glucose (blood sugar) level. IL-1ß in the bloodstream and tissues is thought to contribute to decreased insulin production over time which may result in development of Type 2 diabetes.

The study drug has not yet been tested or approved for reduction of cardiovascular disease events or the development of Type 2 diabetes. Therefore, in this study canakinumab is an “investigational drug.” An “investigational drug” is one that is being tested and is not approved for sale in the United States by the U.S. Food and Drug Administration (FDA). 

This clinical trial will involve approximately 7,302 adult patients in about 700 study centers in 20 countries. We hope to enroll up to 8 subjects here at Northwestern University.

TRYTON Study

The purpose of this clinical study is to evaluate the safety and effectiveness of the Tryton Side Branch investigational stent (the study device) to treat narrowings in coronary arteries that occur in the main body of the coronary artery and in one of the side branches of the artery.  The study device is intended to be used with an FDA approved drug-eluting stent (DES) that is placed in the main body of the blood vessel.  A drug-eluting stent has a drug coating or filling that is meant to prevent tissue re-growth where the stent is placed.  The study device does not have a drug coating or filling.  The study device is investigational, meaning it is not approved for sale in the United States by the U.S. Food and Drug Administration (FDA).

There are two groups in this study.  Subjects may be randomized to: the study device to treat the side branch disease and an FDA approved drug-eluting stent (DES) to treat the main vessel disease OR balloon angioplasty to treat the side branch disease and an FDA approved drug eluting stent (DES) to treat the main vessel disease.

Up to 74 subjects will be treated in Europe, Israel and North America.  Here at Northwestern University we hope to enroll up to 10 subjects

ALERTS (AngeLmed for Early Recognition and Treatment of STEMI) Study

Patients who have increased risk factors of having a heart attack will be asked to participate in this study.  About one million heart attacks occur in the United States each year.  Of those, approximately 400,000 are fatal and as a result, heart attacks remain one of the leading causes of death in the United States.  One important factor that determines a patient's outcome following a heart attack is prompt medical treatment.

This study is being done to evaluate the safety and effectiveness of an investigational diagnostic monitor (The Guardian System), in comparison to the standard of care in treating patients with a high risk of a heart attack.  The Guardian System, which is referred to  as the study device, was developed to help reduce the time it takes patients to seek medical treatment in the emergency room when they have a heart attack.  The study device will be implanted under the skin and will monitor the heart's electrical signals for anything unusual, which may indicate the start of a heart attack.  Once implanted, it will continuously monitor the heart's signal for a specific abnormal heart signal.  If the monitor detects an abnormal heart signal, it will alert the patient to seek medical attention.

The study may involve approximately 3,000 patients at about 50 clinical centers in the United States (US).  We hope to enroll up to 20 subjects here at Northwestern University.