Sudden cardiac arrest (SCA) occurs every 2 minutes throughout the US; most, >70%, occur at home. Because survival falls 10% per minute over the first 10 minutes, it is imperative to defibrillate as close to time zero as possible. Public efforts cannot provide defibrillation fast enough in most cases. We believe the initial shock is best done by the family only seconds from their loved one using readily available automatic external defibrillators (AEDs). AEDs are now simple enough to use that extensive training is no longer required for effective use. Our central hypothesis is that provision of an AED for home use will improve survival beyond that achieved from the typical lay response to SCA. We will test our hypothesis by prospectively randomizing 7,000 patients following anterior myocardial infarction (MI) either to standard lay response to SCA (call emergency medical service (EMS) systems/CPR) or to add the use of a home AED to the standard response. The standard response will be augmented and standardized by the provision of a video on how to respond to SCA and how to perform CPR. Our goal for the standard response is immediate notification of EMS and prompt CPR. Our goal for AED is to shock twice immediately, if indicated by the AED, and call EMS and perform CPR as soon as possible and preferably within 2 minutes of collapse. Although many types of cardiac disease patients are at rick of SCA and could be appropriate candidates for this trial, we chose anterior MI patients, with precordial Q-waves on ECG, primarily because of modest screening costs, ease of identification, and sufficient risk to test the hypothesis. The 7,000 patient population size is dependent upon the assumption that anterior MI patients will have a risk of death of approximately 4% yearly. Patients will be enrolled over 2+ years and followed for an additional 2 years. We hypothesize that mortality will be reduced by 20% in the AED group. The study is powered at 90% with an alpha of 0.05. Treatment arms will be compared using an intention-to-treat analysis. We have one primary specific aim: To compare all-cause mortality in the two arms of the trial. The study will be performed at 200 cardiology clinics and have the acronym HAT for Home AED Trial. Trial management will be by Drs. Gust Bardy, Roger White, Kerry Lee, Melanie Dowdell, WT Longstreth, Jr, Daniel Mark, Douglas Packer, and Jeanne Poole.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01HL067972-03
Application #
6803556
Study Section
Clinical Trials Review Committee (CLTR)
Program Officer
Schron, Eleanor
Project Start
2002-09-30
Project End
2007-08-31
Budget Start
2004-09-01
Budget End
2005-08-31
Support Year
3
Fiscal Year
2004
Total Cost
$4,263,755
Indirect Cost
Name
Seattle Institute for Cardiac Research
Department
Type
DUNS #
012799156
City
Bellevue
State
WA
Country
United States
Zip Code
98116
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Son, Heesook; Thomas, Sue A; Friedmann, Erika (2013) Longitudinal changes in coping for spouses of post-myocardial infarction patients. West J Nurs Res 35:1011-25
Son, Heesook; Friedmann, Erika; Thomas, Sue A (2012) Changes in depressive symptoms in spouses of post myocardial infarction patients. Asian Nurs Res (Korean Soc Nurs Sci) 6:158-65
Son, Heesook; Thomas, Sue A; Friedmann, Erika (2012) The association between psychological distress and coping patterns in post-MI patients and their partners. J Clin Nurs 21:2392-4
Thomas, Sue A; Friedmann, Erika; Lee, Hyeon-Joo et al. (2011) Changes in anxiety and depression over 2 years in medically stable patients after myocardial infarction and their spouses in the Home Automatic External Defibrillator Trial (HAT): a longitudinal observational study. Heart 97:371-81
Friedmann, Erika; Thomas, Sue A; Son, Heesook (2011) Pets, depression and long term survival in community living patients following myocardial infarction. Anthrozoos 24:273-285
Mark, Daniel B; Anstrom, Kevin J; McNulty, Steven E et al. (2010) Quality of life effects of automatic external defibrillators in the home: results from the Home Automatic External Defibrillator Trial (HAT). Am Heart J 159:627-634.e7
Bardy, Gust H; Lee, Kerry L; Mark, Daniel B et al. (2008) Home use of automated external defibrillators for sudden cardiac arrest. N Engl J Med 358:1793-804
Bardy, Gust H; Lee, Kerry L; Mark, Daniel B et al. (2008) Rationale and design of the Home Automatic External Defibrillator Trial (HAT). Am Heart J 155:445-54