Published Online: March 27, 2012. doi:10.1001/jama.2012.426
Author Contributions: Dr Massaro and Ms Ruthazer had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: Selker, Beshansky, Sheehan, Massaro, Griffith, D’Agostino, Atkins, Sayah, Aufderheide, Pirrallo, Opie, Rackley, Apstein, Udelson.
Acquisition of data: Selker, Beshansky, Sheehan, D’Agostino, Atkins, Sayah, Levy, Richards, Aufderheide, Braude, Pirrallo, Doyle, Frascone, Kosiak, Leaming, Van Gelder, Walter, Wayne, Woolard, Udelson.
Analysis and interpretation of data: Selker, Beshansky, Sheehan, Massaro, Griffith, D’Agostino, Ruthazer, Atkins, Aufderheide, Udelson.
Drafting of the manuscript: Selker, Beshansky, Sheehan, Griffith, Atkins, Levy, Aufderheide, Leaming, Walter, Wayne, Opie, Udelson.
Critical revision of the manuscript for important intellectual content: Selker, Beshansky, Sheehan, Massaro, Griffith, D’Agostino, Ruthazer, Atkins, Sayah, Richards, Aufderheide, Braude, Pirrallo, Doyle, Frascone, Kosiak, Leaming, Van Gelder, Wayne, Woolard, Rackley, Udelson.
Statistical analysis: Selker, Beshansky, Massaro, Griffith, D’Agostino, Ruthazer.
Obtained funding: Selker, Beshansky, Griffith, Atkins.
Administrative, technical, or material support: Selker, Beshansky, Sheehan, Atkins, Sayah, Levy, Richards, Braude, Pirrallo, Doyle, Kosiak, Leaming, Van Gelder, Walter, Wayne, Rackley, Udelson.
Study supervision: Selker, Beshansky, Sheehan, Atkins, Sayah, Levy, Richards, Pirrallo, Doyle, Frascone, Van Gelder, Walter, Wayne, Woolard.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Selker, principal investigator, reported institutional receipt of grant funds and indirect payment for his work and travel expenses; the institution's grant paid for honoraria to members of the scientific advisory committee, DSMB, and Harvard Clinical Research Institute for event adjudication and statistical analysis, Curlin Inc for intravenous pumps, and Philips Healthcare for ECG decision support software. Dr Selker also reported an expired patent for the TPI ECG software, but no royalties are received. Ms Beshansky, co-principal investigator, reported institutional and indirect receipt of grant support and support for travel expenses. Dr Massaro reported grant support provided to his institution and direct receipt of funds, in addition to support for travel. Drs D’Agostino and Atkins reported institutional grant support and support for travel expenses. Drs Braude, Doyle, Frascone, Griffith, Leaming, Richards, Udelson, and Woolard, Ms Ruthazer, and Ms Sheehan reported grant support (NIH, NHLBI) provided to their institution. Dr Kosiak reported institutional and direct receipt of funds in support for travel expenses and fees for data review and training. Dr Rackley reported direct receipt of funds for fees for participating on the IMMEDIATE Trial scientific advisory committee. Dr Opie reported consulting fees, support for travel, and fees for scientific advisory committee participation; direct payment for employment (salary) and grants pending (Medical Research Council); and institutional payment for travel (European Society of Cardiology Task Force) outside of the submitted work. Dr Pirrallo reported institutional grant support and support for travel expenses; and relevant but outside of the submitted work he reported direct payment for board membership in National Association of EMS Physicians. Dr Sayah reported institutional receipt of grant support and fees for participating in review activities. Dr Van Gelder reported institutional and direct receipt of grant funds and institutional receipt of funds for provision of equipment and administrative support. Dr Aufderheide reported institutional grant support, support for travel expenses, and provision for software and equipment; also reported as relevant but outside of the submitted work: board membership (volunteer at Citizen CPR Foundation and Take Heart America), consultant (funds to institution, Medtronic Inc), 5 pending emergency research grants (funds to institution, NHLBI, NINDS, Leducq Foundation, Medtronic Foundation); and volunteer member (BLS Subcommittee and Research Working Group, AHA). Dr Wayne reported grant support provided to his institution and direct receipt of funds; also reported, as relevant but outside of the submitted work: direct payment for employment as emergency medicine physician, EMS director, expert testimony, royalties (chest tube by Cook Critical Care), payment for development of educational presentations, and travel expenses for a nonprofit foundation administration. Dr Walter reported institutional receipt of funds for equipment, administrative support, paramedic training, and investigator effort; also reported, relevant but outside the submitted work: receipt of funds for employment as the medical director for the paramedic service at Emerson Hospital. Drs Levy and Apstein reported no conflicts of interest.
Funding/Support: This work was funded by an NIH cooperative agreement from the National Heart, Lung, and Blood Institute (grants U01HL077821, U01HL077826, U01HL077823). National Center for Research Resources (grant UL1RR025752), now at the National Center for Advancing Translational Sciences, provided laboratory testing. Insulin was donated by Eli Lilly and Company. ECG-based decision support software was donated by Physio-Control and Zoll Medical.
Role of the Sponsors: The National Heart, Lung, and Blood Institute participated in the design and conduct of the study but did not participate in the collection, management, analysis, and interpretation of the data; or preparation, review, or approval of the manuscript. The National Center for Research Resources, Eli Lilly and Company, Physio-Control, and Zoll Medical did not participate in the design and conduct of the study; the collection, management, analysis, and interpretation of the data; or preparation, review, or approval of the manuscript.
Additional Contributions: We thank everyone who completed the community consultation survey that supported and allowed the IMMEDIATE Trial to proceed within the communities, and we recognize and thank the study participants. The overall success was a result of many individuals and we especially acknowledge and thank the Coordinating Center staff: Lillian Burdick, Sarina George, Ellen Vickery, Manlik Kwong, Nira Hadar, Viet Cai, William Rui, Sam Yang, Catherine Ide, Carol Seidel, Muriel Powers, and Jordan Goldberg, as well as Patrice Desvigne-Nickens, project officer from NHLBI.
Numerous research coordinators, paramedic coordinators, investigators, research assistants, and paramedics from the participating emergency medical services are thanked for their commitment. Sioux Falls, South Dakota: Michael Deitschman, Rural Metro Ambulance. Macon, Georgia: Kelly Joiner, Glynnis Haley, Medical Center of Central Georgia EMS. Concord, Massachusetts: Joseph Schepis, Patricia Baum, Judy Pendleton, Sergio Waxman, Emerson Hospital EMS. Anchorage, Alaska: Michelle Moore, Michael Crotty, Stephen Poggi, Anne Sigsworth, Jeffrey Myers, Anchorage Fire Department. Albuquerque, New Mexico: Tammy Floore, Drue Bralove, Paul Bearce, Vance Smith, Philip Froman, Silas Bussmann, Susan Salazar, Rae Woods, Kathleen Allen, Albuquerque Ambulance Service, Albuquerque Fire Department, Rio Rancho Fire Rescue, Sandoval County Fire Department. Bellingham, Washington: Janice Lapsansky, Whatcom Medic One EMS. Saint Paul, Minnesota: Sandi Wewerka, Kent Griffith, Joshua Salzman, Marshall Washick, Allen Keith Wesley, Cottage Grove EMS, HealthEast Medical Transportation, Lakeview Hospital EMS, Mahtomedi Fire Department, Maplewood Fire Department, Oakdale Fire Department, White Bear Lake Fire Department. Brockton, Massachusetts: Carol Metral, Richard Herman, Kenneth Lawson, American Medical Response Brockton, Bridgewater Fire Department, Whitman Fire Rescue EMS. Dallas, Texas: Karen Pickard, Ryan Dikes, Raymond Fowler, Jeffrey Goodloe, Wendy Lowe, Claudette Lohr, Timothy Starling, Barbara Moses, Dallas Fire Rescue, Duncanville Fire Department, Irving Fire Department, Plano Fire Department. Hershey, Pennsylvania: Kevin Gardner, Stacey Cleary, Life Lion EMS. Milwaukee, Wisconsin: Milwaukee Fire Department, North Shore Fire Department, Wauwatosa Fire Department, West Allis Fire Department. El Paso, Texas: Adolph Ulloa, Gloria Soto, Susan Watts, El Paso Fire Department. New Haven, Connecticut: Radu Radulescu, Albert Gambino, American Medical Response New Haven, Branford Fire Department, East Haven Fire Department, Hamden Fire Department, New Haven Fire Department, West Haven Fire Department, West Shore Fire District.
We acknowledge the contribution and thank those who were part of the paramedic training efforts (Jon Levine, Stewart Fenniman, Jeanine A. B. Miller, and Louis Durkin, Kelly Hart, Michael Stevens from Medic Ed); data capture, data management, data safety, monitoring, and clinical events adjudication (Kimberlin Marshall, Danielle Rodrick, Deborah Wallace, Claudia Thum, Derek Depelteau from Harvard Clinical Research Institute; and Steve Mayes, Medidata Solutions); laboratory testing (William Harris, Omega Quant Analytics LLC; Free Fatty Acid Laboratory); Debra Kinan, Left Ventricular Core Laboratory; and study drug preparation and distribution (Loreen Wright, Juan Mendez from Central Admixture Pharmacy Services Inc).
Dedication: This article is dedicated to the memory of Dr Carl Apstein, whose work provided a foundation for this study.