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| Participant Education About the PACE-MI Study |
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| General Information |
| What is the research question? |
| Which treatment will I receive? |
| What else is required for the study? |
| Why should I participate? |
| What happens if I decide not to participate in the PACE-MI trial? |
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| About the heart |
| What causes a heart attack? |
| How can I recover? |
| What is bradycardia? |
| What causes heart rhythm disturbances such as bradycardia? |
| How is bradycardia treated? |
| Why can't my doctor just give me the Beta-blockers and a pacemaker? |
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| Study Specific |
| Does participating in the study cost me anything? |
| How many patients will participate in the study? |
| Do I still see my own doctor? |
| What if I am hospitalized during the study? |
| What if I move to another city during the study? |
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| What is the research question? |
| Will combined beta-blocker and pacemaker therapy decrease the chance of another heart attack and improve survival rates for patients with bradycardia after a heart attack? |
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| Which treatment will I receive? |
Your physician may recommend a trial of a low dose beta-blocker after the heart attack. You will be closely monitored for symptoms of bradycardia.
If it is unsafe to start the beta-blocker, you will be randomly (like the flip of a coin) assigned to one of two treatment groups:
CONTROL GROUP - therapy for this group will be conventional treatment for myocardial infarction, but will not include a beta-blocker.
TREATMENT GROUP - therapy for this group will be conventional treatment for myocardial infarction plus implementation of a pacemaker, followed by initiation of beta-blocker therapy. Your doctor may decide to do a trial of low dose beta-blockers before randomizing you into the treatment groups. |
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| What else is required for the study? |
| Regardless of the treatment group, all participants will be scheduled to be seen one, three, and six months after enrollment in the study. After that visit, you will be seen every six months for up to 2 years. Follow up phone calls will be conducted every three months until the last patient completes the study (possibly 5 years). The follow-up visits monitor your cardiac condition and overall health and are a crucial aspect of the study. The research staff will ask you for several contacts (such as neighbors, clergy, co-workers and relatives) in order to stay in touch with you and see how you are doing. |
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| Why should I participate? |
| Although there is no guarantee that you will personally benefit from participation in this study, knowledge gained from your participation may benefit other people with your type of heart disorder in the future. In addition, research studies have consistently shown that patients receiving beta-blockers have an improvement in their survival rates. |
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| What happens if I decide not to participate in the PACE-MI trial? |
| You will continue to visit your doctor for care following a heart attack. |
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| What causes a heart attack? |
Another name for a heart attack is myocardial infarction - "MI" for short. A heart attack occurs when the blood supply to part of the heart muscle itself - the myocardium - is severely reduced or stopped. This usually occurs when one of the arteries that supply blood to the heart muscle (coronary arteries) is blocked by an obstruction. The blockage is usually from the buildup of plaque (deposits of fat-like substances).
A heart attack is often caused by a blood clot forming in a coronary artery. This often results from rupture or tearing of a plaque that has formed. Such an event is sometimes called a coronary thrombosis or coronary occlusion. When the blood supply is stopped or severely reduced to an area of the heart, those cells die giving rise to the heart attack or myocardial infarction. |
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| How can I recover? |
There is good news for people who have had a heart attack. The worst is over, and soon you can do most of the things you used to do! Now is a good time to look at your lifestyle and see if there are ways to make some healthy changes. Heart disease can get worse unless you take steps to get your heart in good shape.
- Depending on the extent of your heart attack, you may only be in the hospital for a few days. Your recovery is just beginning.
- It is very important to start taking steps now to get your heart in good shape and to avoid another heart attack. Eat a healthful diet, exercise, and if you smoke, QUIT!
- Talk with your doctor and nurses about how you can live as normal a life as possible. Ask how soon you can go back to work, drive a car, have sex, and what to do if you have chest discomfort. Your doctor or nurse can answer your questions about other matters, too.
- After a heart attack, it is common to worry. Getting better and feeling good about yourself will take time. It helps to do as your doctor says and to learn about keeping your heart healthy. You have many active years left to enjoy!
- Your doctor will prescribe some medicines for you to take after your heart attack. These medications have been shown to have beneficial effects for patients who have had a heart attack. It is important for you to take your medicine every day. One medication that is commonly prescribed is called a beta-blocker.
- Beta-blockers affect your heart and circulatory system. They reduce the workload on the heart and help it to beat more regularly. They are used after a heart attack. Beta-blockers control, but do not cure high blood pressure (hypertension). High blood pressure may not make you feel sick, but it can lead to serious heart problems. Beta-blockers also relieve chest pain (angina - angina pectoris). Studies show that people who have had a heart attack survive longer if they are treated with beta-blockers.
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| What is bradycardia? |
| The most common medical condition requiring a cardiac pacemaker is called "bradycardia". This is a slow heart rate which is often due to aging of or damage to the heart's electrical system. Bradycardia does not necessarily cause symptoms. However, symptoms of bradycardia (pronounced bray-dee-car-dee-ah) may include dizziness, fatigue, shortness of breath, or fainting spells. By restoring a heart rate to its appropriate rate, a pacemaker can relieve these symptoms. |
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| What causes heart rhythm disturbances such as bradycardia? |
- Certain illnesses or cardiac drugs (such as beta-blockers) may hinder the heart's naturally occurring rhythm. Some drugs, including beta-blockers may cause. bradycardia, lightheadedness or dizziness
- Aging process: The electrical system of the heart may lose some of its ability to initiate or transmit electrical impulses because of the aging process.
- Heart attack: Sometimes, a heart attack, may leave scar tissue that prevents an electrical signal from proceeding through the heart.
- Hereditary heart defect: Hereditary heart defects may affect the heart's rhythm.
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| How is bradycardia treated? |
The most common treatment for symptomatic bradycardia is to implant a permanent pacemaker. A pacemaker is an electronic device that is used to stabilize or stimulate the heartbeat.
Pacing is when a pacemaker sends electrical impulses to your heart through a pacing lead to start a heartbeat. The pacemaker paces the heart when the heart's own rhythm is interrupted, irregular, or too slow.
A pacemaker also has the ability to sense (monitor) the heart's natural electrical activity. If a pacemaker senses a natural heartbeat, it will not deliver a pacing pulse to the heart. |
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| Why can't my doctor just give me the Beta-blockers and a pacemaker? |
| At this point in time, you do not have symptoms related to bradycardia. Medicare does not cover pacemaker implantation for bradycardia without symptoms. Furthermore, there is no information to prove that beta-blockers are effective in patients who already have bradycardia. Only this research study can determine whether implanting a pacemaker in order to be able to initiate beta-blocker therapy is advantageous. |
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| Does participating in the study cost me anything? |
| You and your insurance carrier will be billed for the regular treatment of your heart disease, including the cost associated with the pacemaker implant procedure and the cost of the beta-blocker medication. The pacemaker device is being donated and will not be billed to your insurance. |
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| How many patients will participate in the study? |
| 1124 patients across the country will participate in the study. |
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| Do I still see my own doctor? |
| Your primary physician will continue to manage your medical care. The members of the research study team are intended to serve as an additional support for your current treatment. We will be in constant contact communication with your doctor. We will not take the place of your physician. |
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| What if I am hospitalized during the study? |
| We request that you notify your study nurse if you are hospitalized, even if it is at a different hospital. The study nurse will want to obtain information abuot your care during your hospital stay. |
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| What if I move to another city during the study? |
| If you move or if any contact telephone numbers change, please notify the research staff. If you relocate to another city, the staff will try to arrange follow-up with another study facility or with your physician. |
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