Clinical trial NCT00047411: Home Use of Automatic External Defibrillators to Treat Sudden Cardiac Arrest
Official title: Home Automatic External Defibrillator Trial -- HAT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cardiovascular Diseases
Myocardial Infarction
Heart Diseases
Death, Sudden, Cardiac
Keywords: CPR, AED
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
Collaborators: name: Philips Medical Systems
name: Laerdal Medical
First posted: 2002-10-04
Enrollment: 7001
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To compare home use of an automatic external defibrillator (AED) to the use of local emergency medical system in treating survivors of sudden cardiac arrest.

Detailed description: BACKGROUND:

Sudden cardiac arrest (SCA) occurs every two minutes throughout the United States, with more than 70 percent occuring at home. Because survival falls 10 percent per minute over the first ten minutes, it is imperative to defibrillate as soon as possible. Public efforts cannot provide defibrillation fast enough in most cases. Physicians believe the initial shock is best done using readily available AEDs by family members who are only seconds from their loved one.

DESIGN NARRATIVE:

This study tests the central hypothesis that providing an AED for home use will improve survival beyond that achieved from the typical response to sudden cardiac arrest. An estimated 7,000 people who have had an anterior myocardial infarction will be randomly assigned to one of two groups: 1) a standard response to sudden cardiac arrest, entailing calling an emergency medical service (EMS) system and performing CPR, or 2) the addition 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 sudden cardiac arrest and how to perform CPR. The goal for the standard response will be immediate notification of EMS and prompt CPR. The goal for the AED group will be to shock the cardiac arrest victim up to three times immediately, if indicated by the AED, and call EMS and perform CPR as soon as possible and preferably within two minutes of collapse. Participants will be enrolled for more than two years and followed for an additional two years. The study will be performed at 200 cardiology clinics.

Eligibility criteria: Inclusion Criteria:

* History of anterior myocardial infarction
* Live-in spouse or companion willing to administer CPR or AED therapy plus CPR

Exclusion Criteria:

* Existing implantable cardiac defibrillator or AED
* Current candidate for an implantable cardiac defibrillator
* Current "Do Not Resuscitate" orders

Primary outcomes:
measure: All-cause mortality (measured throughout the study)
timeFrame: Five interim analyses of the data were performed and reviewed by the DSMB
Secondary outcomes:
measure: Survival in the home from cardiac arrest and survival with AED use.
timeFrame: Five interim analyses of the data were performed and reviewed by the DSMB
measure: Quality of life of the participants and their spouses (measured throughout the study)
timeFrame: Five interim analyses of the data were performed and reviewed by the DSMB
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Seattle Institute for Cardiac Research
state: Washington
Study officials:
affiliation: Seattle Institute for Cardiac Research
name: Gust H. Bardy
role: STUDY_CHAIR
References:
citation: Mark DB, Anstrom KJ, McNulty SE, Flaker GC, Tonkin AM, Smith WM, Toff WD, Dorian P, Clapp-Channing NE, Anderson J, Johnson G, Schron EB, Poole JE, Lee KL, Bardy GH. Quality of life effects of automatic external defibrillators in the home: results from the Home Automatic External Defibrillator Trial (HAT). Am Heart J. 2010 Apr;159(4):627-634.e7. doi: 10.1016/j.ahj.2010.01.013.
citation: Bardy GH, Lee KL, Mark DB, Poole JE, Toff WD, Tonkin AM, Smith W, Dorian P, Packer DL, White RD, Longstreth WT Jr, Anderson J, Johnson G, Bischoff E, Yallop JJ, McNulty S, Ray LD, Clapp-Channing NE, Rosenberg Y, Schron EB; HAT Investigators. Home use of automated external defibrillators for sudden cardiac arrest. N Engl J Med. 2008 Apr 24;358(17):1793-804. doi: 10.1056/NEJMoa0801651. Epub 2008 Apr 1.