What Is A Clinical Trial?

A clinical trial is a research study designed to answer an important medical question. Typically, a large number of people, sharing the same medical problem, are asked to enroll in the study. Certain medical information is then collected to provide new insights into their medical conditions.

The investigators (the physicians, nurses and scientists that conduct the work) of a clinical trial are trying to discover the best treatment for a medical problem. One way of doing this is to assign one of two treatments randomly, much like the flipping of a coin. Assigning treatments randomly removes bias or preference that a doctor, nurse or patient may have for or against one treatment.  Bias favoring or disliking a particular therapy, no matter how reasonable it appears, has been shown many times to lead to poorer outcomes. When neither the patient nor their physician know which therapy they will receive, patients almost always do better as long as both options available to them are reasonable, as they are in this trial.

Assigning treatments randomly will be the method used to decide which treatment you will receive if you decide to enroll in this trial, the Home Use AED Trial (HAT). The HAT study will look at two different ways of handling the emergency known as sudden cardiac arrest (SCA).

What Will HAT Do For Me?

Your doctor has already identified the fact that you have had a myocardial infarction (MI) which is a medical term for heart attack. Based on the results of various tests, you may now be taking certain medications to improve your heart condition. With your myocardial infarction stabilized, you are now eligible to enroll in HAT.

HAT will not alter any part of your heart drug treatment. That treatment continues as your doctor has ordered. Your doctor may make changes in your heart drug management or even suggest surgery as your heart condition changes. HAT will not affect that. HAT, rather, evaluates how your spouse or partner can decrease the risk of dying suddenly should you suffer a sudden cardiac arrest (SCA).

There are two basic treatment arms in HAT. One is standard treatment following myocardial infarction combined with video training on how best to respond to a cardiac emergency. The other is standard treatment following myocardial infarction combined with video training on how best to respond to a cardiac emergency plus training a family member on how to use of a device in your home to treat bad heart rhythms that cause SCA. Once you are enrolled in HAT, you will be randomly assigned to one of the treatment arms of the trial. Both arms have slightly different advantages. However, we do not know if you will benefit from enrolling in HAT. By agreeing to participate, you will provide valuable insight to a possible treatment to help people who have had a myocardial infarction live longer and more productive lives.

How Does HAT Work?

HAT will eventually enroll 7000 people with a history of myocardial infarction. There are two usual causes of death in people with previous myocardial infarctions. The first cause is a progressive heart muscle weakness. This can eventually lead to severe heart failure. The second cause is a severe heart rhythm problem that results in a very fast and disorganized heart rhythm called ventricular fibrillation. The HAT study will examine whether a treatment can reduce deaths from ventricular fibrillation.

People with a previous myocardial infarction can die from progressive coronary artery disease that results in a loss of heart muscle strength. Your doctor will make every effort to improve the your coronary artery disease to prevent death from this cause. Your doctor will use standard, well accepted treatments for this problem. The study will not change this.

There is no cost to you for participating in this study. The AED and instructional videos are provided without cost. The majority of the information needed for HAT is available from your regular office visits. If the study requires special information, the costs of those visits will be provided. However, you or your insurance company are responsible for the costs of managing your regular health care including your regular heart care.

Other Information

If you decide to participate in HAT, you will join a multi-center effort throughout the United States, Canada and overseas. This study could determine if there is a "best" therapy to help people like yourself to live longer. You and your family's involvement will make this study possible. Enrolling in HAT involves a commitment from both you and your family. Your commitment is to take all medications prescribed by your doctor and to make regular visits with your doctor and study coordinator. Your family's commitment will be to assume part of the role that emergency medical personnel traditionally had filled exclusively. It also asks that you or your family keep the HAT investigators informed of any changes in your medical condition.

These considerations raise an unpleasant aspect of this study. If you should die, the events surrounding the death are very important to understanding the therapies used in HAT and interpreting the outcome of this trial. Though this is a unpleasant thought, we must ask that your family notify the study team of your death as quickly as possible and help provide the necessary information surrounding your death.

If death occurs, we ask that your family please call the HAT Coordinating Center, toll free at: 1-866-500-4HAT or 1-206-529-8333 overseas. Though a painful time, we ask that your family notify the study team as soon as possible.

For those of you that receive an AED and have used it in the emergency, the information stored within the device is invaluable to this trial. This information can be retrieved in a matter of minutes by the study team. Just contact the HAT Coordinating Center at 1-866-500-4HAT or 1-206-529-8333 (overseas) and we will arrange to pick-up the information.

In turn, the HAT investigators make this commitment to you. We will keep you informed of any significant findings in the treatment of myocardial infarction. We will inform you of any results that might affect your willingness to continue to participate in HAT.

As always, you can choose not to participate in this study. You may withdraw at anytime during the study. Your decision will not affect your heart condition care in any way. Obviously, we hope you decide to enroll. However, we cannot help you with that decision.

You and your family must make that decision together. Unlike many studies, this study will affect both you and your family directly. This study asks for an increased level of involvement by your family. This responsibility is not a light one. It may cause feelings, not only in you but in your loved ones, that are hard to talk about. We, the study staff, are here to answer any questions you might have. Also, we are here to listen as well. The decision to participate will be a difficult one and should not be entered into lightly or without careful consideration. We will do all we can to answer any questions you or your family might have so that you can make your informed decision.

Thank you for your time!