Home Use of Automatic External Defibrillators to Treat Sudden Cardiac Arrest (HAT)
Primary Purpose
Cardiovascular Diseases, Myocardial Infarction, Heart Diseases
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Cardiopulmonary Resuscitation
Automatic External Defibrillation
Sponsored by
About this trial
This is an interventional prevention trial for Cardiovascular Diseases focused on measuring CPR, AED
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
Sites / Locations
- Seattle Institute for Cardiac Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
1
2
Arm Description
Intervention: Immediate notification of EMS by telephone and prompt initiation of CPR, in accordance with published Basic Life Support guidelines.
Use of the AED first, in accordance with published guidelines for AED use, followed by a call to EMS and perform CPR as in the control group.
Outcomes
Primary Outcome Measures
All-cause mortality (measured throughout the study)
Secondary Outcome Measures
Survival in the home from cardiac arrest and survival with AED use.
Quality of life of the participants and their spouses (measured throughout the study)
Full Information
NCT ID
NCT00047411
First Posted
October 3, 2002
Last Updated
March 6, 2008
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborators
Philips Medical Systems, Laerdal Medical
1. Study Identification
Unique Protocol Identification Number
NCT00047411
Brief Title
Home Use of Automatic External Defibrillators to Treat Sudden Cardiac Arrest
Acronym
HAT
Official Title
Home Automatic External Defibrillator Trial -- HAT
Study Type
Interventional
2. Study Status
Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
September 2002 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
September 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborators
Philips Medical Systems, Laerdal Medical
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Myocardial Infarction, Heart Diseases, Death, Sudden, Cardiac
Keywords
CPR, AED
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
7001 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Intervention: Immediate notification of EMS by telephone and prompt initiation of CPR, in accordance with published Basic Life Support guidelines.
Arm Title
2
Arm Type
Experimental
Arm Description
Use of the AED first, in accordance with published guidelines for AED use, followed by a call to EMS and perform CPR as in the control group.
Intervention Type
Other
Intervention Name(s)
Cardiopulmonary Resuscitation
Intervention Description
Immediate notification of EMS by telephone and prompt initiation of CPR, in accordance with published Basic Life Support guidelines
Intervention Type
Device
Intervention Name(s)
Automatic External Defibrillation
Intervention Description
Use the AED first, in accordance with published guidelines for AED use, followed by a call to EMS and perform CPR as in the control group.
Primary Outcome Measure Information:
Title
All-cause mortality (measured throughout the study)
Time Frame
Five interim analyses of the data were performed and reviewed by the DSMB
Secondary Outcome Measure Information:
Title
Survival in the home from cardiac arrest and survival with AED use.
Time Frame
Five interim analyses of the data were performed and reviewed by the DSMB
Title
Quality of life of the participants and their spouses (measured throughout the study)
Time Frame
Five interim analyses of the data were performed and reviewed by the DSMB
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gust H. Bardy
Organizational Affiliation
Seattle Institute for Cardiac Research
Official's Role
Study Chair
Facility Information:
Facility Name
Seattle Institute for Cardiac Research
City
Seattle
State/Province
Washington
ZIP/Postal Code
98103
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20362722
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.
Results Reference
derived
PubMed Identifier
18381485
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.
Results Reference
derived
Learn more about this trial
Home Use of Automatic External Defibrillators to Treat Sudden Cardiac Arrest
We'll reach out to this number within 24 hrs