IMMEDIATE TRIAL INFORMATION
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January 2010 - Rio Rancho, New Mexico

Rio Rancho, New Mexico will begin enrolling patients into the IMMEDIATE Trial by the end of January. The ACI-TIPI software is now available on the Philips electrocardiograph, thus allowing Rio Rancho to join the Albuquerque Site. Rio Rancho is located just outside of Albuquerque. Rio Rancho Fire Rescue is the provider of EMS care for the city. The 40 paramedics cover a population of over 80,000 people spread across 73 square miles. Nine ambulance units and two fire trucks staffed with paramedics provide 911 response and patient transportation. Patients are often transported to one of Albuquerque’s hospitals making transport times as long as 20 minutes.

The paramedic team will be led by EMS Battallion Chief Paul Bearce and EMS Captain Jimmy De Fillippo with Dr. Darren Braude as their medical director. While considered part of the Albuquerque Site, Rio Rancho will operate independently. We welcome them to the Trial.

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August - September 2009 - 5th Anniversay

In July of 2003, the IMMEDIATE Trial Coordinating Center at Tufts Medical Center in Boston, Massachusetts submitted a grant application to the National Heart Lung and Blood Institute (NHLBI) of the National Institutes of Health (NIH). The idea was that this treatment for heart attacks, GIK, while of no interest to drug companies for a trial because there is no profit to be made in a non-patented treatment, it would be of importance to the public and thus it would make sense for it to be funded by the federal source for biomedical research, NIH. On September 1, 2004 the Coordinating Center’s investigators were notified that the study would be funded and preparation began, processes were developed, training modules were written, paper and electronic systems were put into place, documents were submitted to the Food and Drug Administration (FDA), institutional review boards approved the study’s protocol and in October 2006 the very first patient was enrolled into the study.

Now, five years later, with 490 patients enrolled, we are all part of a major enterprise with the possibility of changing care for heart attacks in this country, and the practice of EMS medicine. The national Coordinating Center’s 25 individuals and the 38 individuals who help run the study at the 8 Sites currently enrolling patients, along with over 1,000 paramedics, together make this study work. With just over one more year of enrollment to go, we are all looking forward to being part of answering a question that has lingered for 40+ years: does GIK successfully reduce harm from heart attacks?

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July 2009 - Concord, MA

In 2003, the pilot study for the IMMEDIATE Trial was done in Concord, Massachusetts by the hospital-based EMS system located at Emerson Hospital. The EMS system’s 30 paramedics enrolled 29 patients and helped to establish the foundation for the current study’s procedures for screening and enrollment, and they continue to be a key site in the IMMEDIATE Trial. Their one truck provides ALS response to a population of 156,000 covering 230 square miles and 13 separate communities whose fire departments provide BLS level care. Each month, the paramedics screen an average of forty patients and enroll one to two patients into the IMMEDIATE Trial.

The Site is led by the Research Coordinator, Joe Schepis, EMT-P and Site PI Dr. Gert Walter and they are supported by additional staff located at the PCI-capable receiving hospital, the Lahey Clinic and include the nurse researchers Patricia Baum, RN and Judy Pendleton, RN; and Investigator Dr. Sergio Waxman.

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June 2009 - El Paso, Texas

El Paso, the newest site to join the IMMEDIATE Trial, started enrolling patients in February 2009. El Paso Fire Department EMS is the provider of mobile intensive care unit care for the City of El Paso. The 130 paramedics serve a population of approximately 712,000 and cover over 248 square miles. The 21 ambulance units and five paramedic pumpers provide 911 response and patient transportation. Patients are transported to six receiving hospitals in the city of El Paso: Thomason Hospital, Del Sol Medical Center, Las Palmas Medical Center, Sierra Medical Center, Providence Memorial Hospital and Sierra Providence East Medical Center.

The paramedic team is led by Medical Deputy Chief, Janet Walker and Medical Lieutenant, Larry Rascon of the El Paso Fire Department. The research team is located at Texas Tech University Health Sciences Center and includes Susan Watts, Adolph Ulloa, Todd Haugen, Gloria Soto, Sally Morales, and Site PI, Dr. Robert Woolard. Each month, the paramedics screen on average 250 patients and enroll six to seven patients into the IMMEDIATE Trial.

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May 2009 - New Haven, Connecticut

The New Haven Sponsor Hospital Program coordinates emergency medical service in the New Haven and surrounding areas. There are 220 paramedics serving a population of approximately 500,000. The participating services, American Medical Response (AMR), Branford Fire Department (FD), East Haven FD, Hamden FD, New Haven FD, West Haven Center District and West Shore FD transport patients enrolled in the IMMEDIATE Trial to two receiving hospitals: Yale-New Haven Hospital and the Hospital of Saint Raphael. The Research Coordinator, Laurie Thomas, oversees the Trial’s operations and coordinates the hospital component and data collection processes. The Paramedic Coordinator, Abe Colon, coordinates the Trial’s EMS operations. The team is led by Dr. Carin Van Gelder, Site Principal Investigator and EMS Medical Director.

Each month, the paramedics screen approximately 180 patients and enroll 3 to 5 patients into the IMMEDIATE Trial.

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April 2009 - Bellingham, Washington

Whatcom Medic One is operated by the Bellingham Fire Department. It is the provider of ALS care for the City of Bellingham and surrounding Whatcom County. Forty-five paramedics serve a population of approximately 225,000 and cover over 2,200 square miles. Four full-time and one back up ALS unit plus one EMS captain provide ALS response and patient transportation. Three of the units are located in Bellingham, and two are located in northwestern and central Whatcom County. Patients are transported to one receiving hospital, St. Joseph Hospital, located in Bellingham. The paramedic team is led by four EMS Captains, Mannix McDonnell, Erica Martin, Scott Farlow, and Sean Farnand who together coordinate the prehospital component of the Trial. The Research Coordinator, Janice Lapsansky, oversees the Trial’s operations and coordinates the hospital component and data collection process. The team is supported by Dr. Marvin Wayne, Site Principal Investigator and EMS Medical Director.

Each month, the paramedics screen approximately 200 patients and enroll 2 to 4 patients into the IMMEDIATE Trial.

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March 2009 - Anchorage, Alaska

The Anchorage Fire Department (AFD) serves as an emergency medical service (EMS) for the municipality of Anchorage, encompassing 1,980 square miles. The fire-based EMS system has 8 mobile intensive care units as well as first responding ALS and BLS engine companies and employs 66 paramedics to serve a population of 260,000. Patients enrolled in the IMMEDIATE Trial are transported to two receiving hospitals: Alaska Regional Hospital and Providence Alaska Medical Center.

The Site EMS team is led by the EMS Battalion Chiefs: Mike Crotty, EMT-P, Steve Poggi, EMT-P and Anne Sigsworth, EMT-P. Research Coordinator’s Jenny Price, RN and Jeff Myers, RN coordinate the hospital component and data collection for the Trial. The team is supported by Dr. Michael Levy, Site Principal Investigator and AFD’s EMS Medical Director.

Each month, the paramedics screen approximately 175 patients and enroll 2 to 4 patients into the IMMEDIATE Trial.

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February 2009 - Macon, Georgia

The Medical Center of Central Georgia (MCCG) EMS serves the City of Macon and surrounding area. The EMS system has 24 ambulances and employs 85 paramedics to serve a population of over 240,000 people in Bibb, Jones, Twiggs and Baldwin Counties. They deliver patients to one receiving hospital for the IMMEDIATE Trial: Medical Center of Central Georgia.

The Site is led by the Research Coordinator, Kelly Joiner, EMT-P, MCCG's EMS Assistant Director. The IMMEDIATE Trial is implemented and carried out entirely by the EMS Team. A team of paramedics are the Study Coordinators and are responsible for obtaining consent, completing data collection and ensuring that all policies and procedures for the study are done in accordance with the Protocol. The team includes Christina DeBona, EMT-P; Sam Hutto, EMT-P; Carmela Herndon, EMT-P; Shane Byous, EMT-P; and Justin Swearingen, EMT-P. The team is supported by Dr. Delanor Doyle, Site Principal Investigator and EMS Medical Director; and Lee Oliver, Director of MCCG's EMS system.

Each month, the paramedics screen 200 to 250 patients and enroll 3 to 4 patients into the IMMEDIATE Trial.

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January 2009 - Albuquerque, New Mexico

The Albuquerque Site is the largest site currently enrolling in the IMMEDIATE Trial. It includes three EMS systems that together serve approximately one million people in an area covering 181 square miles. Patients enrolled in the IMMEDIATE Trial are transported to one of four receiving hospitals in the City of Albuquerque. The research staff is located at the University of New Mexico Health Sciences Center Department of Emergency Medicine and serves as the local Trial's Coordinating Center.

Albuquerque Ambulance Service (AAS), Albuquerque Fire Department (AFD) EMS and Sandoval County Fire Department (SCFD) EMS worked as a team to ensure paramedics from all three systems completed the IMMEDIATE Trial's training requirements. Together these systems will fill out over 500 Screening Forms per month.

Combined, AFD, SCFD and AAS employ more than 250 paramedics and have more than 50 ALS units stocked with the IMMEDIATE Trial study drug. These agencies work together to provide first response, scene control, patient assessment, stabilization, treatment and transport for all patients, including those enrolled in the IMMEDIATE Trial.

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December 2008 - Sioux Falls, South Dakota

Rural/Metro Ambulance serves as the sole ambulance provider in the city of Sioux Falls and surrounding area.  The EMS system has 9 ambulances and employs 35 paramedics to serve a population of over 150,000 people in southeastern South Dakota.  They deliver patients to three receiving hospitals for the IMMEDIATE Trial; Avera Heart Hospital of South Dakota, Avera McKennan Hospital and University Health Center, and Sanford USD Medical Center.

This Site is led by the Research Coordinator, Michael Deitschman, BA, NREMT-P, who is also responsible for the quality improvement (QI) process and is the Supply Coordinator for Rural/Metro Ambulance.  Also on this Site’s IMMEDIATE Trial research team are Tim Rave, NREMT-P, Research Coordinator and Operational Manager; Donald Kosiak, MD, Site Principal Investigator and EMS Medical Director; and Mary Helen Harris, MD, Site Investigator.

The paramedics in Sioux Falls screen 40 to 50 patients and enroll 2 to 3 patients per month. The uniqueness of this Site’s implementation of the IMMEDIATE Trial is that this Site is led by paramedics who are responsible for obtaining consent, completing data collection and ensuring that all policies and procedures for the study are done in accordance with the Protocol.

Visit Participating Sites for more information.

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October 2008 - The IMMEDIATE Trial is currently enrolling in the following cities:
Albuquerque
Anchorage
Concord
Macon
New Haven
Sioux Falls
Visit Participating Sites for details.

July 2008 - The Society for Heart and Vascular Metabolism’s 6th annual conference was held in Boston from June 29th through July 1st, 2008. Members of the IMMEDIATE Trial’s Scientific Advisory Committee, Drs. Lionel Opie and Joanne Ingwall, made positive and encouraging comments about the IMMEDIATE Trial and its potential findings based on the scientific evidence that was presented at the meeting.

June 2008 - Letters to the editor published in JAMA: Selker, H et. al. “No causal relationship to a safety problem related to GIK.” Opie, L. “IMMEDIATE Trial to give valuable information.” Chaudhuri, A et. al. “Insulin may add more benefit than we know.” JAMA.2008;299(20):2385-6.

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May 2008 - Review article by Robert Kloner and Richard Nesto (Circulation. 2008 May 13;117(19):2523-33) supports “GIK administration in the pre-hospital setting during acute coronary syndrome (ACS).”

May 2008 - 3 patients enrolled in 3 days - Milwaukee Site enrolled 3 successive STEMI patients who underwent PCI!

April 2008 - Sioux Falls Site begins enrollment – Rural/Metro Ambulance of Sioux Falls, South Dakota, enrolls first patient on the very same day!

December 2006 - Journal of Emergency Medical Services
Priority Traffic - Paramedics Participate in $36 Million Cardiac Study

July 2006 - Cable Network Channel Video, Dallas, TX
Interview with Dr. James Atkins, Texas Regional Principal Investigator

July 07, 2006 - Fifty Plus Advocates, Concord, MA
Metrowest-area Ambulance Transports Slated for Heart Attack Study

June 24, 2006 - The Dallas Morning News, Dallas, Texas
Efforts Against Heart attack Pumped Up

June 12, 2006 - Star Community Newspaper, Plano, Texas
Plano Chosen to Take Part in Clinical Trial

April 21, 2006 - The Enterprise Newspaper, Brockton MA
Brockton to Join Study of Heart Attack Medication

September 2005 - Press Release Tufts Medical Center, Boston, MA
National IMMEDIATE Trial Funded by NHLBI of NIH to Test Inexpensive Widely-Applicable “GIK” Emergency Treatment for Heart Attack for Use in Ambulances and Emergency Departments.

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