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| Sponsors and Collaborators: |
National Heart, Lung, and Blood Institute (NHLBI) Philips Medical Systems Laerdal Medical |
|---|---|
| Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
| ClinicalTrials.gov Identifier: | NCT00047411 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cardiovascular Diseases Myocardial Infarction Heart Diseases Death, Sudden, Cardiac |
Other: Cardiopulmonary Resuscitation Device: Automatic External Defibrillation |
Phase III |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Home Automatic External Defibrillator Trial -- HAT |
| Estimated Enrollment: | 7001 |
| Study Start Date: | September 2002 |
| Study Completion Date: | September 2007 |
| Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
Intervention: Immediate notification of EMS by telephone and prompt initiation of CPR, in accordance with published Basic Life Support guidelines.
|
Other: Cardiopulmonary Resuscitation
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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Device: Automatic External Defibrillation
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.
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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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Washington | |
| Seattle Institute for Cardiac Research | |
| Seattle, Washington, United States, 98103 | |
| Study Chair: | Gust H. Bardy | Seattle Institute for Cardiac Research |
More Information
| Responsible Party: | Seattle Institute for Cardiac Research ( Gust H. Bardy, MD ) |
| Study ID Numbers: | 147, U01 HL67972 |
| Study First Received: | October 3, 2002 |
| Last Updated: | March 6, 2008 |
| ClinicalTrials.gov Identifier: | NCT00047411 |
| Health Authority: | United States: Federal Government |
|
CPR, AED |
|
Necrosis Death Heart Diseases Myocardial Ischemia Death, Sudden Vascular Diseases |
Heart Arrest Ischemia Death, Sudden, Cardiac Infarction Myocardial Infarction |
|
Pathologic Processes Cardiovascular Diseases |
