Research Trials in the Center for Coronary Disease

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.

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.

ROMICAT: Rule Out Myocardial Ischemia/Infarction Using Computer Assisted Tomography: A Randomized, Controlled, Multicenter, Diagnostic Trial

The purpose of this study is to find out  if a test called "cardiac computed tomogaphy angiography (CTA)" can help doctors in the emergency department (ED) safely and rapidly detect whether current symptoms are related to disease in the blood vessels of the heart.  Computed tomography (CT) or "cat scan" is a radiology test routinely used for diagnostic purposes.  Cardiac CT is a diagnostic test already approved to care for patients seen in the emergency department (ED) with chest discomfort.  It is a newer way of looking at the arteries that supply blood and oxygen to the heart ("coronary arteries").  If these arteries are clogged this may cause chest pain or even a heart attack.  The images of the coronary arteries obtained by CT scanners (during a 5 - 10 minute procedure) have been shown by many studies to be accurate, when compared to the gold standard conventional invasive cardiac catheterization procedure.  We are looking to see if a safe, more efficient diagnosis of chest discomfort can be made which will not only ensure safe, timely care, but also decrease cost.

The results of the Cardiac CT will be compared to other tests whice are routinely used in the ED for chest pain diagnosis - physical exam, measurement of blood markers (chemicals whose increase can indicate an injury of your heart muscle), electrocardiogram (ECG - a recording of your heart's electrical activity) and heart perfusion imaging (a procedure that can visualize the heart muscle's blood supply).  People who agree to take part in this study will be randomly selected either to receive an initial cardiac CT scan or not in addition to the other tests in the ED.  Based on prior studies, the researchers doing the present study believe that CT scanning of the coronary arteries can provide information that is just as safe and accurate as other techniques used to assess for heart disease, and can do so more rapidly at a lower cost.

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.