ANNOUNCEMENT: Request for expression of interest in participation in an emergency medical services (EMS) clinical trial of acute myocardial infarction

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Purpose of Announcement: NIH IMMEDIATE Trial Site Expansion - Request

for expression of interest in participation in an emergency medical

services (EMS) clinical trial of acute myocardial infarction

Response Due Date: September 30, 2007

Sponsor: National Institutes of Health (NIH) National Heart, Lung and

Blood Institute (NHLBI) ative Agreement with Tufts New England

Medical Center

Study Description: The IMMEDIATE (Immediate Myocardial Metabolic

Enhancement During Initial Assessment and Treatment in Emergency care)

Trial is a study of a potentially important and effective treatment for

patients having an acute myocardial infarction (AMI). The IMMEDIATE

Trial is testing whether early intervention of an intravenous (IV)

glucose, insulin and potassium (GIK) solution can decrease mortality of

patients having an AMI. This randomized placebo-controlled

double-blinded study will determine if the GIK solution will decrease

mortality and preserve myocardial function among patients who call 911

for a possible AMI. The EMS system's standard of care for patients with

acute coronary syndrome (ACS) is followed and the IMMEDIATE Trial is an

adjunct to the standard of care. The paramedic makes the decision to

enroll a patient in the IMMEDIATE Trial based on a screening process

that includes the prehospital 12-lead electrocardiogram (ECG) and their

assessment of the patient. Before enrollment begins in a community

served by a participating emergency medical services (EMS) system, a

number of organizational, regulatory and training requirements need to

be completed. An overview of the key elements for a Site to participate

in the IMMEDIATE Trial is provided below.

If you want to learn more about the IMMEDIATE Trial and have your EMS

system considered as a possible Site:

1. Contact the IMMEDIATE Trial Coordinating Center at

IMMEDIATE-Trial@... or call .

2. Visit the IMMEDIATE Trial website at

<http://immediatetrial.com/>.

Leadership and Physician Requirement

The EMS system and its receiving hospitals together make up an IMMEDIATE

Trial " Site. " A Site must have a designated principal investigator

(PI), often the EMS medical director, but a Site may have more than one

active investigator. Assistance is provided from key physician

representatives from the emergency departments (EDs) and cardiology

departments at one or more selected receiving hospitals.

Paramedic Participation Requirement

All paramedics from the EMS system must participate and agree to undergo

8 hours of study-related training. In addition, their compliance with

study-related procedures will be monitored throughout the study's

patient enrollment period. The paramedics' specific responsibilities

include identifying eligible patients, completing a paper screening form

on such patients, assessing patient's willingness to participate in a

clinical study, preparing the study drug, administrating the study drug

via an IV pump, documenting actions related to the study, notifying

medical control and/or research team about enrollment, and ensuring the

enrolled patient's smooth transition to the ED staff.

EMS System Requirement

The EMS system must require the paramedic to acquire prehospital 12-lead

ECGs as part of their standard of care for patients with suspected ACS.

Capacity for 12-lead ECGs must be present in all involved ambulances,

and the EMS system must be willing to install the ACI-TIPI (acute

cardiac ischemia time-insensitive predictive instrument) and

thrombolytic predictive instrument cardiac predictive instrument

software (to be provided by the electrocardiograph's manufacturer) on

their prehospital defibrillator/12-lead electrocardiographs. The

paramedics will be trained in the use of the ACI-TIPI and thrombolytic

predictive instrument, and their printouts on the ECG will assist

paramedics in identifying ACS, AMI, and ST elevation MI, and will be

used as part of the screening process for enrollment into the IMMEDIATE

Trial.

Information Technology (IT) Infrastructure Requirement

Ideally, participating EMS systems will currently download all ECGs into

a centralized database. However, EMS systems willing to establish an

electronic ECG database or to conduct systematic manual monitoring of

ECG acquisition will be considered. Paramedics will need personal

computer (PC) access and Internet access for the web-based training

modules unless an EMS system elects to have paramedic training conducted

in a group environment. Additionally, the research team will need PC

access and Internet access for their data entry into the web-based data

collection system.

Receiving Hospitals Requirement

All hospitals that receive patients from a participating EMS system will

be asked to participate in the Trial and allow for continuation of the

study drug infusion for a total of 12 hours for each patient. Each

hospital's IRB will review the IMMEDIATE Trial Protocol from the

perspective of what is required once the patient arrives at the

hospital. ED staff will accept the study drug packet, inform others

(when giving report) that the patient is enrolled in the IMMEDIATE

Trial, and write orders to continue the study drug.

Regulatory Requirement

The IMMEDIATE Trial has obtained an investigational new drug (IND)

number from the Food and Drug Administration (FDA) and is in compliance

with their request in addition to the preference of the Office for Human

Research Protection (OHRP), this Protocol is being conducted under the

regulation 50.24 " Exception from Informed Consent Requirements for

Emergency Research " therefore requiring community consultation and

public disclosure; a complete plan, materials and assistance will be

provided by the Coordinating Center. In practice, before starting the

study drug, the patient is notified of the study and the study drug is

started in the ambulance, and complete written informed consent is

obtained at the hospital.

Data Collection

All data collection is done via a sophisticated web-based system that

will require training of the research team. (Paramedics are not trained

on this system, as their only data collection is on the paper screening

form.) The research team will obtain copies of source documents

(prehospital patient care record and hospital medical record) and

abstract data related to the events associated with this

hospitalization. Each enrolled patient is followed for one year and

will be contacted by the research team at 30-days, 6-months and 1-year

to determine vital status.

Budgetary Expectations

Each Site will be compensated in accordance with its contribution to

Trial enrollment, with additional start-up funds determined by the

Site's size based on the population served by its EMS system(s) and the

number of receiving hospitals.

Thank you,

Harry P. Selker, MD, MSPH

Study Chair / Principal Investigator

IMMEDIATE Trial

Coordinating Center

Institute for Clinical Research and Health Policy Studies

Tufts New England Medical Center

750 Washington Street, # 63

Boston, MA 02111