HOME AUTOMATIC EXTERNAL DEFIBRILLATOR TRIAL --H.A.T.

家用自动体外除颤器试用--H.A.T.

• 批准号: 7125029
• 负责人: Gust Harry Bardy
• 金额: $ 211.46万
• 依托单位: SEATTLE INSTITUTE FOR CARDIAC RESEARCH
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-09-30 至 2009-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7125029
• 关键词: artificial respiration; behavioral /social science research tag; cardiopulmonary resuscitation; caregivers; clinical research; cooperative study; electric countershock heart resuscitation; electrocardiography; emergency care; emergency health services; health care service evaluation; health services research tag; human mortality; human subject; implantable defibrillators; myocardial infarction; patient oriented research; self care; sudden cardiac death; training; videotape /videodisc

DESCRIPTION (provided by applicant): 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.

描述（由申请人提供）： 心脏骤停（SCA）在整个美国每2分钟发生一次；大多数（> 70％）出现在家里​​。 由于在前10分钟内存活率下降了10％，因此必须将尽可能接近零时间的除颤。 在大多数情况下，公共努力不能足够快地提供除颤。 我们认为，最初的冲击是最初的震动，只有他们所爱的人只能使用随时可用的自动外部除颤器（AED）来完成。 现在，AED很简单，可以使用大量的培训才能有效使用。 我们的核心假设是，提供房屋使用的AED将提高生存率，而不是对SCA的典型外行反应所获得的生存。 我们将通过前瞻性地将7,000名患者随机对SCA​​（致电紧急医疗服务（EMS）Systems/CPR）进行标准的外行响应，或者将家庭AED添加到标准响应中，从而检验7,000名患者，以测试我们的假设。 标准响应将通过提供有关如何响应SCA以及如何执行CPR的视频来增强和标准化。 我们对标准响应的目标是立即通知EMS并提示CPR。 AED的目标是立即震惊两次，如果AED表示，请致电EMS并尽快执行CPR，最好在倒塌后2分钟内进行。 尽管许多类型的心脏病患者处于SCA的瑞克（SCA），并且可能是该试验的合适候选者，但我们选择了前MI患者，其前Q波的前Q波在ECG上，主要是因为适度的筛查成本，易于识别和足够的风险来检验假设。 7,000名患者人群的大小取决于MI前患者每年死亡的风险约为4％的假设。 患者将在2年以上招收，并额外招募2年。 我们假设在AED组中，死亡率将降低20％。 该研究的α为90％，α为0.05。 将使用意向性分析比较治疗臂。 我们有一个主要的特定目的：比较试验两个臂中的全因死亡率。 这项研究将在200个心脏病学诊所进行，并具有家庭AED试验的首字母缩写帽。 试用管理将由Drs。 Gust Bardy，Roger White，Kerry Lee，Melanie Dowdell，WT Longstreth，Jr，Daniel Mark，Douglas Packer和Jeanne Poole。

项目成果

Outcomes for patients with anterior myocardial infarction and prior cardiac arrest in the home automated external defibrillator trial (HAT).

家庭自动体外除颤器试验 (HAT) 中前壁心肌梗死且既往心脏骤停患者的结果。

• DOI: 10.1016/j.resuscitation.2021.08.047
• 发表时间: 2021
• 期刊: Resuscitation
• 影响因子: 6.5
• 作者: Starks,MoniqueAnderson;Jackson,LarryR;Hellkamp,Anne;Al-Khatib,SanaM;Mark,DanielB;Thomas,KevinL;Nichol,Graham;Lee,KerryL;Davidson-Ray,Linda;Poole,Jeanne;Anderson,Jill;Johnson,George;Bardy,GustH
• 通讯作者: Bardy,GustH

Rationale and design of the Home Automatic External Defibrillator Trial (HAT).

家用自动体外除颤器试验 (HAT) 的基本原理和设计。

• DOI: 10.1016/j.ahj.2007.12.008
• 发表时间: 2008
• 期刊: American heart journal
• 影响因子: 4.8
• 作者: Bardy,GustH;Lee,KerryL;Mark,DanielB;Poole,JeanneE;Toff,WilliamD;Tonkin,AndrewM;Smith,Warren;Dorian,Paul;Yallop,JulieJ;Packer,DouglasL;White,RogerD;Longstreth,Will;Anderson,Jill;Johnson,George;Bischoff,Eric;Munkers,C
• 通讯作者: Munkers,C

Quality of life effects of automatic external defibrillators in the home: results from the Home Automatic External Defibrillator Trial (HAT).

家庭自动体外除颤器对生活质量的影响：家庭自动体外除颤器试验 (HAT) 的结果。

• DOI: 10.1016/j.ahj.2010.01.013
• 发表时间: 2010
• 期刊: American heart journal
• 影响因子: 4.8
• 作者: Mark,DanielB;Anstrom,KevinJ;McNulty,StevenE;Flaker,GregC;Tonkin,AndrewM;Smith,WarrenM;Toff,WilliamD;Dorian,Paul;Clapp-Channing,NancyE;Anderson,Jill;Johnson,George;Schron,EleanorB;Poole,JeanneE;Lee,KerryL;Bardy,Gust
• 通讯作者: Bardy,Gust

The association between psychological distress and coping patterns in post-MI patients and their partners.

心肌梗死后患者及其伴侣的心理困扰与应对模式之间的关联。

• DOI: 10.1111/j.1365-2702.2012.04165.x
• 发表时间: 2012
• 期刊: Journal of clinical nursing
• 影响因子: 4.2
• 作者: Son,Heesook;Thomas,SueA;Friedmann,Erika
• 通讯作者: Friedmann,Erika

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.

家庭自动体外除颤器试验 (HAT) 中心肌梗死后病情稳定的患者及其配偶在 2 年内焦虑和抑郁的变化：一项纵向观察研究。

• DOI: 10.1136/hrt.2009.184119
• 发表时间: 2011
• 期刊: Heart (British Cardiac Society)
• 作者: Thomas,SueA;Friedmann,Erika;Lee,Hyeon-Joo;Son,Heesook;Morton,PatriciaG;HATInvestigators
• 通讯作者: HATInvestigators