In the United States there are about 800,000 heart attacks a year resulting in about 500,000 deaths. Identifying heart attack symptoms quickly and calling for help to get treatment as early as possible is very important. Mercer University (Mercer) and the Medical Center of Central Georgia (MCCG) in Macon, Georgia are taking part in a nationwide study to test if an intravenous solution of glucose, insulin, and potassium in addition to standard treatment, can help save lives.
A 36 million dollar grant from the National Heart Lung Blood Institute (NHLBI) of the National Institutes of Health (NIH) was awarded to the Tufts Medical Center’s Institute for Clinical Research and Health Policy Studies (ICRHPS) in Boston, Massachusetts, the location of the National Coordinating Center. The IMMEDIATE (Immediate Myocardial Metabolic Enhancement During Initial Assessment and Treatment in Emergency care) Trial will determine if an intravenous “GIK” solution of glucose (sugar), insulin, and potassium (represented as “K” chemically) can reduce the likelihood of death from heart attack. The IMMEDIATE Trial will test whether GIK can prevent threatening heart attacks from occurring, and for heart attacks already underway, whether GIK can decrease serious complications and death. The study will include patients when they first present with symptoms of a heart attack to emergency medical system (EMS) ambulances in cities and towns throughout the United States (currently including Massachusetts, Texas, Wisconsin, Alaska, New Mexico, Connecticut and South Dakota). The IMMEDIATE Trial should provide an answer to whether this commonly-available inexpensive treatment will have as dramatic an impact as some initial studies have suggested. If so, used in ambulances, GIK could save the lives of tens of thousands of patients with threatening or ongoing heart attacks in the United States each year.
Previous studies suggest that this study solution is most helpful when given as soon as possible after heart attack symptoms start. In this research study, patients with symptoms of a heart attack who call 911, will be given the study solution by paramedics in the ambulance on the way to the hospital. Patients will be randomized to receive either the standard solution (plain sugar water), or GIK, the study solution that is a combination of glucose (sugar water), insulin (a hormone), and potassium (a mineral). Because this is a study, at that point, neither the patients nor the paramedics will know which solution the patient is receiving. The patient will continue to receive the study solution for up to 12 hours along with all their other treatments. Giving the study solution will not interfere with routine care for a heart attack in the ambulance or at the hospital.
A heart attack occurs when blood flow in the coronary arteries to the heart muscle is blocked by a clot (a “thrombosis”). Immediate GIK treatment may protect the heart muscle that is not receiving sufficient blood flow, and thus it may prevent heart muscle damage that might otherwise lead to immediate death, or to long-term heart failure. Thus, for patients having acute coronary syndromes (“ACS,” which includes both heart attack and unstable angina pectoris, which can turn into a heart attack), the IMMEDIATE Trial will test whether emergency treatment with intravenous GIK will reduce death from heart attacks and, for survivors of heart attacks, will reduce progression to heart failure. This will include investigating whether GIK can lengthen the time window during which patients can benefit from coronary artery reperfusion (clot-buster thrombolytic therapy or coronary angioplasty and stents) and will include investigation of GIK’s impact on other aspects of the treatment of ACS.
Rapid and accurate identification of patients who have ACS for GIK treatment will be crucial to having optimal impact. Thus, in the ambulances, the electrocardiographs used to initially evaluate patients with chest pain and other symptoms suggestive of ACS will be equipped with two cardiac predictive instruments previously developed by the Tufts Medical Center researchers: the acute cardiac ischemia time-insensitive predictive instrument (ACI-TIPI) and the thrombolytic predictive instrument (TPI), both now incorporated into conventional computerized electrocardiographs. The ACI-TIPI and TPI assist emergency physicians and paramedics by providing predictions printed on the top of the electrocardiogram: the probability that the patient is having acute cardiac ischemia (synonymous with ACS), the probability of mortality from heart attack, and the probability of the key clinical outcomes of heart attack, if given (or if not given) thrombolytic therapy. These decision aids have been the subject of multicenter clinical trials run by the Tufts Medical Center team, including a 10,700-patient national trial in 10 hospitals of the ACI-TIPI, and a 1,200-patient 28-hospital national trial of the TPI, in which they showed improved diagnostic and treatment decisions in the care of patients with likely heart attack, laying the foundation for their use in the IMMEDIATE Trial.
Macon’s IMMEDIATE Trial Team
In close collaboration with the team at the National Coordinating Center, the Macon IMMEDIATE Trial Team will include EMS personnel (Lee Oliver, Director of EMS and Kelly Joiner, Assistant Director of EMS, and Dr. Ralph Griffin, Medical Director of EMS, all located at MCCG), and the Mercer research team (Dr. Erskine James, Cardiologist, and Glynnis Haley, Nurse Practitioner).
For questions please contact Dr. Erskine James, Site Principal Investigator (478-301-5960) or Lee Oliver, Director of EMS at Medical Center of Central Georgia (478-633-1931) or the Coordinating Center at 617.636.8787 or visit http://www.immediatetrial.com/.
About The Medical Center of Central Georgia
The Medical Center of Central Georgia (MCCG), an entity of Central Georgia Health System (CGHS), is a designated Level I Trauma Center and Magnet(tm) hospital for nursing serving the residents of Central and South Georgia with a primary and secondary service area of 28 counties and a population of nearly 750,000 people. The Medical Center has approximately 5,000 employees and a medical staff of more than 500 physicians. MCCG is the second largest hospital in Georgia with a capacity of 637 beds including medical-surgical, obstetric, pediatric, psychiatric, cardiac intensive care, neurology intensive care, pediatric intensive care, and cardiac surgery intensive care. Thirty-four beds are leased to Regency Hospital of Central Georgia, a long-term, acute-care facility. Central Georgia Rehabilitation Hospital, an entity of CGHS, partners with MCCG to provide a 58-bed, medical-rehabilitation hospital for pediatric, adult, and geriatric patients. MCCG is the primary academic hospital for Mercer University School of Medicine, providing residency programs for almost 100 residents. MCCG provides a broad range of community-based, outpatient diagnostic, primary care, urgent-care services, extensive home-health and hospice-care services, as well as comprehensive rehab services. MCCG provides ambulance service to the citizens of Bibb, Baldwin, Jones, and Twiggs counties.The Medical Center of Central Georgia…striving to make excellence a daily standard.
About the Mercer University School of Medicine
Celebrating its 25th year, Mercer University’s School of Medicine was established in 1982 to educate physicians and health professionals to meet the primary care and health care needs of rural and medically underserved areas of Georgia. The School only accepts Georgia residents into its medical degree program. Students entering Mercer University School of Medicine will be graduated from a school that utilizes a problem-based medical education program that provides early patient care experiences. Such an academic environment fosters the early development of clinical problem-solving and instills in each student an awareness of the place of the basic medical sciences in medical practice. In June 2007, the University announced it would expand its two-year clinical program at Memorial University Medical Center into a second full, four-year doctor of medicine program by fall 2008. The School also offers master’s degrees in public health, family therapy, and nurse anesthesia.
About Mercer University
Founded in 1833, Mercer University is a dynamic and comprehensive center of undergraduate, graduate and professional education. The University has 7,300 students; 11 schools and colleges – liberal arts, law, pharmacy, medicine, business, engineering, education, theology, music, nursing and continuing and professional studies; major campuses in Macon, Atlanta and Savannah; four regional academic centers across the state; a university press; two teaching hospitals – Memorial University Medical Center and the Medical Center of Central Georgia; educational partnerships with Warner Robins Air Logistics Center in Warner Robins and Piedmont Healthcare in Atlanta; an engineering research center in Warner Robins; a performing arts center in Macon; and a NCAA Division I athletic program. For more information, visit www.mercer.edu.
