PITTSBURGH, December 14, 1999 — In an effort to determine if a more efficient response to people suffering heart attacks is possible, the University of Pittsburgh Department of Emergency Medicine is participating in a multi-center study on the use of a standard drug usually administered inside the hospital that will be given for the first time by paramedics outside the hospital.
Retavase is a U.S. Food and Drug Administration-approved, clot-busting drug used to treat heart attacks. This study marks the first time it will be used in people before they get to the hospital. Paramedics will administer the drug after an EKG assessment with portable equipment and consulting with a physician via telephone at a participating hospital. The time saved may reduce the number of deaths and the amount of heart muscle damaged by a heart attack.
"I am looking forward to seeing the results of this study. Previous research has shown that the earlier clot-busting drugs are administered, the better the outcome will be for the patient," says Vincent N. Mosesso, M.D., assistant professor of emergency medicine at the University of Pittsburgh School of Medicine and medical director of pre-hospital care at University of Pittsburgh Medical Center and principal investigator of the Pittsburgh study.
Paramedics employed by Mutual Aid EMS in Greensburg, Pa., Fayette County EMS and Frick Hospital Response Team will administer the drug with direction by the Medical Command Physicians at Westmoreland, Frick, Brownsville, Highlands, Jeannette and Uniontown hospitals.
When paramedics arrive on the scene where a person is suffering a heart attack, they identify themselves as participating in the study with the University of Pittsburgh. While paramedics are assessing the patient, they will briefly explain the study and how Retavase is used for the treatment of heart attacks. Once the paramedics and consulting physician have determined if the person is eligible for the study, the patient will be asked to provide his or her consent to participate in the study and to receive the Retavase, which will then be administered intravenously. There is no cost involved, nor will any compensation be provided for participating in this study. People with a history of stroke, severe hypertension or recent surgery are not eligible.
Paramedics involved in the project have completed both an orientation and a training course prepared by study investigators. Lessons covered in training include the fundamentals of EKG assessment, orientation to the study protocol, including eligibility criteria, the thrombolytic checklist, the informed consent process, as well as preparation and administration of Retavase.
Approximately 2,000 people from 20 centers throughout the United States and Canada will be selected for the study. Before selection into the study, people must meet specific criteria. Participants must be 18 years of age or older, have chest pain lasting 30 minutes or more, and have EKG evidence of a heart attack. One thousand participants will receive Retavase outside the hospital. Results will be compared to another 1,000 patients who received the drug in the hospital to determine if there are differences in the patients’ outcomes.
"The use of a combination of clot-busting drugs early in the course of a heart attack is one of the most exciting findings in cardiology today," says Joon Lee, M.D., director, interventional cardiology at the University of Pittsburgh Heart Institute and co-principal investigator with Dr. Mosesso.
The Pennsylvania Department of Health, Office of EMS, has certified all paramedics participating in this project. This study is also supported by the Pittsburgh Center for Emergency Medicine.