|What is the IMMEDIATE TRIAL?
Many Hospitals and Emergency Medical Services have been selected to participate in a nationwide study that is testing whether administration of Glucose, Insulin and Potassium, referred as “GIK” is helpful to patients at the first signs of a heart attack.
What will the IMMEDIATE TRIAL do for me?
By administering GIK early upon onset of symptoms in the ambulance, it may have the potential to protect the heart muscle from damage until other therapies are available at the hospital.
How does the Paramedic decide who to put in the study?
Paramedics are trained to identify patients by following very strict inclusion criteria. If you are having heart attack symptoms, such as chest pain or shortness of breath, are at least 30 years old and have positive findings for a heart attack on your electrocardiogram (ECG or EKG), the paramedics caring for you may decide that you are eligible for the study. However, if you show signs of heart or kidney failure, you will not be considered for the study.
All potential study participants will be considered equally regardless of race, ethnicity, religion, education or financial status.
Do I have to participate in the study?
You do not have to participate. If the paramedic believes that you meet all the study criteria, he/she will read an information card to you about the study and then give you the option to decline participation before starting the study drug. Full informed consent will not occur prior to receiving the treatment. However, you or a family member will be provided with more detailed information about the study once you are medically stable at the emergency department at which time you can decide not to continue with the study drug (full informed consent process).
If I participate, what is involved in the study?
As part of usual treatment, an intravenous (IV) is placed with a standard solution. If you participate, you will be randomly assigned an additional IV solution of either the study drug (GIK) or placebo (the standard solution of sugar and water). Half of the patients will get GIK and the other half will get placebo. A placebo is an inactive substance which looks exactly like the experimental drug, but is not expected to have any medical effects. This means you may or may not receive the drug being tested.
Which study solution you receive is determined by chance; neither you nor the treating medical staff will know which you are getting unless it becomes medically necessary to know. You will receive the solution for 12 hours unless you are discharged, change your mind, or the treating physician feels that there is clinical reason to stop the study solution. All usual treatments and care will continue while in the study and thereafter.
Blood tests to look for enzymes that indicate a heart attack will be drawn as part of routine care. Other blood tests to measure potassium and glucose levels will be a part of the routine testing for the study as well.
You will be contacted three times during the following year. At 30 days, 6 months, and 1 year, a member of the research team will call to ask questions about your health since you received the study drug.
Are there any risks to my participating?
The aim of the study is to reduce the damage to the heart muscle, but there is no guarantee of benefit. The study drug is easily administered and associated with few side-effects. Possible but infrequent side effects associated with GIK are redness or inflammation at the IV site, change in blood sugar levels that may cause a feeling of weakness, dizziness, or thirstiness, elevated or lowered potassium levels that may result in a change of heartbeat or dizziness or the IV solution may cause extra fluid in the body. You will be monitored for these problems and you will receive treatment if necessary.
If you are pregnant during the time of the study drug infusion, it is possible that there may be risks to your unborn child, but none are currently known.
What happens if I find out that I am not having a heart attack and the study solution was already started?
The study solution will be stopped. The research team will then contact you in approximately 24 hours to follow-up on the status of your health.
What if I change my mind about participating?
You are not required to participate. If you are enrolled in the study and you decide that you do not want to participate, you only need to tell the treating paramedic or physician that you do not want to be in the study.