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What is the difference between a heart attack and a cardiac arrest?
Answer: A heart attack is an event in which blood flow to part of the heart is decreased and, as a result, a portion of the heart muscle dies. Cardiac arrest, which most commonly happens because of a heart attack, is when the blood flow within the patient stops because of the patient’s heart has stopped beating. With rapid treatment, some people who suffer a sudden cardiac arrest can be saved.
What is the standard of care for a patient in cardiac arrest?
Answer: At present, a great deal of controversy exists regarding the standard of care. For some time, it was believed that the more rapidly the patient received care in the form of a defibrillator, the more likely they were to survive. But recent studies have brought this standard of care into question and have suggested that a period of CPR prior to the first use of a defibrillator may improve the likelihood that some patients will survive. At present, the American Heart Association describes both as a standard of care and encourages the development of defibrillators whose computer algorithms might better distinguish which patients are best served by each of these standards.
Will patients receive the standard of care in the SmartCPR Trial?
Answer: Yes. Patients will be assigned to either immediate defibrillation or CPR prior to defibrillation, both of which are acceptable standards according to the American Heart Association’s most recent “Guidelines.”
Where will the SmartCPR Trial take place?
Both the FDNY and London Ambulance Service are presently participating in the study, and the potential exists for more sites to be added in the future. In New York City, all certified first responder engines, basic life support ambulances, and supervisory vehicles with automated external defibrillators will participate in the trial - about 850 defibrillators in all.
How will patients be chosen for the SmartCPR Trial?
Answer: All patients in cardiac arrest who are first cared for by the previously described FDNY personnel will be enrolled in the study.
How many patients will the SmartCPR Trial include?
Answer: Initial estimates for the study suggest that 1,000 cardiac arrest patients who present in ventricular fibrillation will be needed. Based on known rates of ventricular fibrillation in New York City, this will likely mean that 7,000 patients will need to be enrolled among all sites.
What are the risks associated with this trial?
Answer: Because the study utilizes the same automated external defibrillator presently used by the FDNY, and because the two treatments that may be provided are both considered to be standards of care, the risks are limited. As with any device, mechanical failure is always possible.
Will patient consent be required for this study?
Answer: No. Studies meeting a set of very specific requirements may request a “waiver of informed consent,” as was done in this study. The decision to grant a waiver of informed consent lies with the Institutional Review Board (IRB), a required body whose responsibility includes the oversight of clinical studies. The actions / activities required of the study investigators are drawn from guidelines put forth by the United States Food and Drub Administration, including requirements for both community consultation and public notification.
This website serves as part of the requirements for this study’s public notification. Additional efforts have included an FDNY press release and letters to community leaders such as the borough presidents, community board chairs, and city council.
Who oversees the SmartCPR Trial?
Answer: The oversight of this study is provided by a number of individuals and groups. The principal investigator, site investigators, sponsor investigator and study coordinators are listed elsewhere in this website (click here).
In addition, all clinical trials are required to have an Institutional Review Board (IRB) that is responsible for overseeing the study. The New York City Department of Health has authorized its IRB to serve in this capacity for the SmartCPR Trial. (Click here to find out more about the IRB.)
Finally, trials utilizing a waiver of informed consent process are required to have one final layer of oversight. This body, called the Data Safety Monitoring Board, is responsible for periodically reviewing the study data and all events with potential adverse effects to patients. If significant benefit or harm is found during the course of a study, even before its intended stopping point, this body can recommend the early termination of a study.