Wishard Health Services to Investigate New Cardiac Devices Aimed at Improving Survival Rate for Heart Attack Victims
February 23, 2009
Contact: Todd Harper
Phone: 317-630-7808
Pager: 317-310-5972
Indianapolis, February 23, 2009 - Wishard Health Services in partnership with the Indianapolis Fire Department, Carmel Fire Department and St. Vincent Hospital will participate in a landmark research study to evaluate the effectiveness of two investigational biomedical devices that may change the way cardiopulmonary resuscitation (CPR) is delivered. The two investigational devices are called ResQPOD and ResQPump and preliminary studies indicate that these devices improve blood flow during CPR, which may improve survival after cardiac arrest.
The ResQPump and the ResQPOD are currently being used in a medical research study known as the ResQ Trial. It is sponsored by Advanced Circulatory Systems, Eden Prairie, MN.
"The study devices greatly increase blood flow to the heart and brain during CPR and may prove to increase survival in victims of sudden death due to a heart attack," said Dr. Michael Olinger, medical director of Emergency Medical Services at Wishard, director of the Division of Out of Hospital Care for the IU School of Medicine’s Department of Emergency Medicine and the principal investigator of the local study. "It is important to participate in this study because the results may revolutionize the treatment of the thousands of people each year who unexpectedly suffer a premature death due to cardiac arrest."
"The care of the cardiac arrest victim is a collaboration between first responders, emergency medical services, the emergency department, the critical care team and cardiology. This study will provide a great opportunity to further the care and treatment of cardiac arrest patients in this most critical period," said Dr. Richard Kovacs, chief of cardiology service at Wishard Health Services, clinical director of the Krannert Institute of Cardiology and professor of clinical medicine at the IU School of Medicine.
Because it is not possible to obtain informed consent from people who are in cardiac arrest, this study meets the U.S. Food and Drug Administration’s requirements for an exception from informed consent for emergency research. This type of research has been allowed since 1996 under a ruling called "exception from informed consent" or EFIC. It allows research without the standard requirement that before patients can be enrolled in a randomized study; they or their representatives must give "informed consent." This type of study offers an important opportunity to expand treatment options for patients in cardiac arrest.
The FDA requires researchers to consult with the community prior to initiating this research. Therefore, a series of community meetings with healthcare providers, community leaders and representatives from community organizations will be held prior to the start of the study period. The purpose of these meetings is to inform the community of this research activity; explain the nature of the research project, its goals and objectives, and the protocol associated with it; and gather feedback from valued members of the community.
The schedule of community meetings planned to inform the public about the ResQ Trial includes:
- March 3 at 5 p.m., North Arlington Health Center, 2505 N. Arlington Ave., Indianapolis, IN 46218
- March 5 at 7:30 p.m., Carmel Fire Department Station #41, 2 Civic Square Carmel, IN 46032 in the Training Room
- March 9 at 7:30 p.m., 3930 Georgetown Road, Indianapolis, IN, 46254 (Drive on the north side of the building until you reach the end of the parking lot. Enter the building and turn right. The meeting will be in the EMS education area.)
- March 10 at 7 p.m., 3930 Georgetown Road, Indianapolis, IN, 46254
- March 11 at noon, Blackburn Health Center, 2700 Dr. Martin Luther King Jr. Street, Indianapolis, IN 46208
Heart disease is currently the leading cause of death in North America. Unfortunately, many individuals with heart disease suffer what is known as "cardiac arrest" - an emergency situation where the heart suddenly stops, placing the person at risk for permanent brain damage or death. Only about 1 in 20 cardiac arrest victims survive, and of those who do, many have permanent brain damage. Faced with these dismal statistics, medical researchers are constantly searching for better treatments for cardiac arrest.
Wishard Health Services is the lead research institution for the local study along with the Indianapolis Fire Department, Carmel Fire Department and St. Vincent Hospital. Other local hospitals and Emergency Medical Services providers expected to participate in the study include Community Hospital East, Community Hospital North, Community Hospital South, Methodist Hospital and Speedway Fire Department.
Members of the public who have questions or wish to decline participation in this study may contact one of the study’s research coordinators at 317-287-3029.
About Wishard Health Services
For 150 years, Wishard Health Services has provided high quality, cost-effective healthcare to the citizens of Marion County. Wishard is accredited by the Joint Commission. Nationally recognized programs include a level I trauma center, regional burn center, comprehensive senior care program, women’s and children’s services, Midtown Community Mental Health Center, and a network of primary care sites located throughout the neighborhoods of Indianapolis. Wishard Health Services is the public hospital division of the Health and Hospital Corporation of Marion County and partners with the Indiana University School of Medicine whose physicians provide a comprehensive range of primary and specialty care services.
About Advanced Circulatory Systems
Advanced Circulatory Systems' mission is to restore life and improve the quality of life for patients experiencing cardiac arrest, low blood pressure and head injury by developing new technologies to noninvasively increase circulation throughout the body, providing improved opportunity for survival and quality of life. The company manufactures and markets the ResQPOD, an impedance threshold device and it has recently introduced the ResQGARD™ to treat low blood pressure in spontaneously breathing patients. The ResQPOD (Perfusion on Demand) ITD 10.0 is used to increase blood flow to vital organs in patients who require assisted breathing (e.g. cardiac arrest). The ResQPOD is now in use at over 1,200 hospitals and EMS systems in the US.