Penn State Hershey Medical Center will begin heart attack study

Life Lion Emergency Medical Service and Penn State Milton S. Hershey Medical Center have received approval to begin participation in a heart attack study called the IMMEDIATE Trial.

This National Institutes of Health-sponsored research study will test if an intravenous solution of glucose, insulin and potassium can reduce the likelihood of death from a heart attack. Patient enrollment will start this month and will continue for up to one year.

Patients with symptoms of a heart attack, who are at least 30 years old and have positive findings on an EKG done by an EMS paramedic, may be enrolled in the trial. People with signs of heart failure and those receiving dialysis will not be enrolled.

Due to the emergency nature of a heart attack, patients will not be able to give informed consent prior to starting the study drug. In the ambulance, the paramedics will notify patients of the study and they can decide to accept or decline participation. More detailed information will be provided at the hospital, and at that time patients can provide informed consent to continue or withdraw.

Study participants will receive either a standard IV solution or glucose-insulin-potassium solution for 12 hours. Which solution received is determined by chance. Neither the patient nor the medical staff will know which one has been assigned. All patients continue to receive standard care normally given.

Previous studies have shown that giving glucose-insulin-potassium as early as possible may protect the heart from damage until further therapies are available. However, there is no guarantee of benefit for trial participants. Possible side effects include redness or inflammation at the IV site; change in blood sugar levels that may cause weakness, dizziness or thirstiness; change in potassium levels that may result in a rapid heartbeat or dizziness. Patients are monitored for side effects and treated if needed.

Use of the exception from informed consent provision in a study protocol is granted by the Institutional Review Board (IRB) responsible for the initial and continuing review and approval of the research study. Such a decision is based on the finding and documentation that, among other things, patients are in a life-threatening situation requiring emergency medical intervention, currently available treatments are unproven or unsatisfactory, obtaining informed consent is not feasible, potential risks are reasonable in relation to what is known of the condition, participation in the study could provide a direct benefit to the patients enrolled, and the research could not be practicably conducted without an exception from informed consent.

Patients may withdraw from the study at any time, with no disruption in care.

For more information, call 717-531-1707 or visit the trial website at www.IMMEDIATETrial.com. Study director is James Leaming, M.D.

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Last Updated August 09, 2010