Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00047411
Status:
COMPLETED
Last Update Posted:
2008-03-10
First Post:
2002-10-03
Brief Title:
Home Use of Automatic External Defibrillators to Treat Sudden Cardiac Arrest
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
Home Automatic External Defibrillator Trial -- HAT
Status:
COMPLETED
Status Verified Date:
2008-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HAT
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 7000 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
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 7000 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01HL067972 | NIH | None | httpsreporternihgovquickSearchU01HL067972 |