Home Use of Automatic External Defibrillators to Treat Sudden Cardiac Arrest (HAT)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00047411 |
|
Recruitment Status :
Completed
First Posted : October 4, 2002
Last Update Posted : March 10, 2008
|
- Study Details
- Tabular View
- Results Submitted
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cardiovascular Diseases Myocardial Infarction Heart Diseases Death, Sudden, Cardiac | Other: Cardiopulmonary Resuscitation Device: Automatic External Defibrillation | Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 7001 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
| Official Title: | Home Automatic External Defibrillator Trial -- HAT |
| Study Start Date : | September 2002 |
| Actual Primary Completion Date : | September 2007 |
| Actual Study Completion Date : | September 2007 |
| Arm | Intervention/treatment |
|---|---|
|
Active Comparator: 1
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 |
|
Experimental: 2
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.
|
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. |
- All-cause mortality (measured throughout the study) [ Time Frame: Five interim analyses of the data were performed and reviewed by the DSMB ]
- 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 ]
- 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 ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00047411
| United States, Washington | |
| Seattle Institute for Cardiac Research | |
| Seattle, Washington, United States, 98103 | |
| Study Chair: | Gust H. Bardy | Seattle Institute for Cardiac Research |
| Responsible Party: | Gust H. Bardy, MD, Seattle Institute for Cardiac Research |
| ClinicalTrials.gov Identifier: | NCT00047411 |
| Other Study ID Numbers: |
147 U01HL067972 ( U.S. NIH Grant/Contract ) |
| First Posted: | October 4, 2002 Key Record Dates |
| Last Update Posted: | March 10, 2008 |
| Last Verified: | March 2008 |
|
CPR, AED |
|
Cardiovascular Diseases Heart Diseases Myocardial Infarction Death, Sudden, Cardiac Infarction Death, Sudden Ischemia |
Pathologic Processes Necrosis Myocardial Ischemia Vascular Diseases Death Heart Arrest |