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| ID | Type | Description | Link |
|---|---|---|---|
| U01HL067972 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Philips Medical Systems | INDUSTRY |
| Laerdal Medical | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Intervention: Immediate notification of EMS by telephone and prompt initiation of CPR, in accordance with published Basic Life Support guidelines. |
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| 2 | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiopulmonary Resuscitation | Other | Immediate notification of EMS by telephone and prompt initiation of CPR, in accordance with published Basic Life Support guidelines |
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| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality (measured throughout the study) | Five interim analyses of the data were performed and reviewed by the DSMB |
| Measure | Description | Time Frame |
|---|---|---|
| Survival in the home from cardiac arrest and survival with AED use. | Five interim analyses of the data were performed and reviewed by the DSMB | |
| Quality of life of the participants and their spouses (measured throughout the study) | Five interim analyses of the data were performed and reviewed by the DSMB |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gust H. Bardy | Seattle Institute for Cardiac Research | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seattle Institute for Cardiac Research | Seattle | Washington | 98103 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20362722 | Derived | 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. | |
| 18381485 | Derived | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 9, 2009 | |
| Reset | Mar 5, 2009 | |
| Release | Mar 17, 2009 |
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| Automatic External Defibrillation | Device | 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. |
|
| Reset | Apr 21, 2009 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 9, 2009 | Mar 5, 2009 | |||
| Mar 17, 2009 | Apr 21, 2009 |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D009203 | Myocardial Infarction |
| D006331 | Heart Diseases |
| D016757 | Death, Sudden, Cardiac |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D006323 | Heart Arrest |
| D003645 | Death, Sudden |
| D003643 | Death |
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| ID | Term |
|---|---|
| D016887 | Cardiopulmonary Resuscitation |
| ID | Term |
|---|---|
| D012151 | Resuscitation |
| D004638 | Emergency Treatment |
| D013812 | Therapeutics |
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