Welcome to the DETERMINE Trial website for study personnel

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For more information about the DETERMINE Trial please contact us by email at determine@northwestern.edu or by calling 866-929-0990.

Introduction

The DETERMINE Trial, which stands for DEfibrillators To REduce Risk by MagnetIc ResoNance Imaging Evaluation, is coordinated by Northwestern University and supported by St. Jude Medical, Inc. The study will enroll approximately ten thousand people across the United States with Coronary Artery Disease (CAD) to help find other methods for identifying those who may be at risk for developing abnormal heart rhythms that might result in Sudden Cardiac Death (SCD).

People with CAD who have a mild to moderate decrease in heart-pumping function may be at risk for developing abnormal heart rhythms that might result in Sudden Cardiac Arrest (SCA). SCA is a sudden, unexpected event that occurs when the electrical impulses in a diseased heart become very irregular. This irregular heart rhythm (arrhythmia) causes the heart to suddenly stop beating. SCA leads to sudden cardiac death. SCD is the largest cause of natural death in the United States with more than 80% of events occurring in individuals with CAD which results in over 400,000 deaths each year.

Study Design

There are two phases of this study. The first part is the DETERMINE Registry. A Registry is a place where information is gathered, stored and made available for research. One purpose of this Registry is to gather information to increase our knowledge of how the amount of heart muscle damage (scar) as seen on MRI (Magnetic Resonance Imaging) may help predict SCD. Another purpose of this Registry is to look for people who might qualify for a more focused research study.

The focused research study, the DETERMINE Trial, will try to find out if an Implantable Cardioverter Defibrillator (ICD) will improve survival in people with CAD. Specifically for those with mild to moderate decreases in heart-pumping function and a specified amount of scar as seen on your MRI.

Cardiac Magnetic Resonance Imaging

An MRI machine uses a powerful magnetic field, radio waves, and a computer to produce detailed pictures of organs, soft tissues, bone and virtually all other internal body structures. The images can then be examined on a computer monitor or printed on film. MRI does not use x-rays. Cardiac MRI creates images of the heart as it's beating, producing both still and moving pictures of the heart and major blood vessels.

Doctors use cardiac MRI to look at the structure and function of the heart. These images can help them decide how best to treat patients with heart problems.

Single MRI images are called slices. The images can be stored on a computer or printed on film. MRI can easily be performed through clothing. However, because the magnet is very, very strong, certain types of metal can cause changes in the magnetic field produced by the machine and errors in the images.

Background Medical Conditions

Sudden Cardiac Arrest (SCA) and Sudden Cardiac Death (SCD) are major health problems, claiming over 400,000 lives every year in the United States. SCA accounts for about 19% of all deaths in the United States. Some SCA victims may not know that they are at risk of SCD right up to the moment when SCA strikes.

SCA is caused by abnormal rapid heartbeats. Rapid heart beats are known as an arrhythmia (a RITH me uh). SCA is an electrical conduction problem and is not the same as a heart attack. A heart attack is caused by a blocked artery leading to loss of blood supply to a portion of the heart muscle.

People who have had a previous heart attack have a 4-6 times higher risk of SCA than the general population. In people diagnosed with Congestive Heart Failure (CHF; a decrease in the pumping of the heart), SCA occurs at 6-9 times the rate of the general population. In approximately 94-95% of cases, SCA is fatal leading to sudden cardiac death.

Coronary Artery Disease (CAD) is narrowing or complete blockage of a coronary artery that may have resulted in the death of heart muscle cells (heart attack) supplied by that artery. Damaged heart muscle becomes a scar when it heals and this scar may result in the mild to moderate decrease in heart pumping function. One method to identify the amount of heart muscle damage (scar) is a cardiac MRI scan. People who are found to have heart muscle damage may be at risk for developing rapid abnormal heart rhythms that might result in cardiac arrest and possible sudden death.

At present, there are some medications that can be taken by people who have CAD and a previous heart attack to help protect them from SCA and SCD, but other possible ways of caring for and treating people with this medical condition are not clear. Recent research has shown that people who have a severe decrease in heart-pumping function have a survival benefit from the use of an ICD. Current medical practice is to implant an ICD in patients with CAD and a severe decrease in heart-pumping function to prevent sudden cardiac death. In this study we are trying to see if ICDs will help prevent sudden cardiac death in people with CAD and mild to moderate reduced heart pumping function.

Treatment Options

At the present time, there are medications that help control the symptoms of CAD. However, we are not sure of the best way to prevent sudden cardiac death due to the life-threatening arrhythmias that may occur. A life threatening arrhythmia or SCA typically can be reversed, but only if treated within minutes with an electrical shock via an Automated External Defribillator (AED) or with an ICD.

ICDs have been shown to be effective in converting certain types of arrhythmias back to a normal heart rhythm in patients with a servere decrease in heart-pumping function. An ICD does not prevent an abnormal heart rhythm from occurring; it rapidly detects and treats the abnormality, restoring a normal heart rhythm before the event becomes life-threatening. This study will help decide whether the implantation of an ICD in patients with a mild to moderate decrease in heart-pumping function is better at improving survival than using standard medical therapy alone.

What is an ICD and How Is It Implanted?

ICD stands for Implantable Cardioverter-Defibrillator. An ICD may also be called an ICD "pulse generator". The ICD used in this study is approved for use by the United States Food and Drug Administration (FDA) for people with a severe decrease in heart-pumping function.

An ICD corrects some rapid, abnormal heart rhythms. The ICD is set to watch for harmful, rapid heart rates. When the ICD recognizes an arrhythmia, it sends electrical energy to the heart muscle through implanted wires or "leads". The electrical energy slows the heart, restoring a more normal heart rate.

A typical ICD device is small in size; it often weighs four to five ounces and is less than 2 inches wide and half an inch thick. The device is roughly the size of a small deck of cards. Wires or "leads" inserted through your veins connect the ICD "pulse generator" to the heart. Through the use of electronic circuitry, the battery powered ICD pulse generator is able to monitor the heart's rhythm and deliver treatment when necessary.

The ICD is implanted during a surgical procedure. Medication will be given to help promote relaxation during the surgery. The leads are inserted through a large vein and guided towards the heart. A small incision is made to make a "pocket" or pouch just under the skin. Next, the leads are connected to the ICD. The doctor will put the ICD in this pocket to firmly hold it in place. Once the procedure is completed, patients are discharged home either the same or the next day depending on their condition.

For more information about ICDs refer to the St. Jude Medical, Inc. Website www.sjm.com

Are There Any Risks to Participating in a Research Study?

The best source of information about the potential risks involved in this study is the study doctor. A clinical research study involving an investigational product is an experiment to test the safety and effectiveness of the product. As a result, participation in this study may have risks to a person's health. These risks will depend on the type of study and how much is already known about the product. The risks may be no more than an unpleasant side effect that goes away quickly, or they may lead to a life-threatening condition. It is possible that the product will be found ineffective for your condition and does not improve your health. The clinical investigator or study staff member should talk to you about all the reasonably foreseeable risks of participating in the clinical research study.

While it may not be possible to eliminate all risks associated with participation in a clinical research study, steps should be taken in all such studies to reduce possible risks. The precautions taken in this study include the development of a study protocol that explains exactly how the clinical investigator is to conduct the clinical research study, and review and approval of the study by an Institutional Review Board (IRB).

What Are The Benefits to Participating in a Research Study?

The reasons for deciding to participate in a clinical research study are very personal, but some of the reasons that have been identified by research participants include participation in order to add to the underdstanding of the product, which may help others in the future. Others want the opportunity to possibly receive investigational products that are only available in a clinical research study. Still others, in exploring all their medical options, view the opportunity to participate in a clinical research study as a way to play an active role in their health care.

Summary

The DETERMINE Trial will provide valuable information about the risk factors for sudden cardiac death and whether or not an ICD will improve survival in patients who have coronary artery disease with a mild to moderate decrease in heart-pumping function and heart muscle damage as seen on a cardiac MRI.

About the Bluhm Cardiovascular Institute's Clinical Trials Unit of Northwestern University

The Bluhm Cardiovascular Institute's (BCVI) Clinical Trials Unit (CTU) of Northwestern University was established at Northwestern University in 2005 to provide the infrastructure necessary to assist investigators in performing high quality cardiovascular clinical research. The mission of the CTU is to facilitate innovative clinical research with the goal of advancing scientific knowledge, the prevention of disease and improving healthcare for all patients. We strongly believe that research should focus on advancing the practice of medicine and improving the quality of patient care.

This content was approved by the Northwestern University IRB.

DETERMINE Trial Information

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