Home Use of Automatic External Defibrillators to Treat Sudden Cardiac Arrest (HAT)

March 6, 2008 updated by: National Heart, Lung, and Blood Institute (NHLBI)

Home Automatic External Defibrillator Trial -- HAT

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

7001

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98103
        • Seattle Institute for Cardiac Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
All-cause mortality (measured throughout the study)
Time Frame: Five interim analyses of the data were performed and reviewed by the DSMB
Five interim analyses of the data were performed and reviewed by the DSMB

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
Five interim analyses of the data were performed and reviewed by the DSMB

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborators

Laerdal Medical
Philips Medical Systems

Investigators

  • Study Chair: Gust H. Bardy, Seattle Institute for Cardiac Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2002

Primary Completion (Actual)

September 1, 2007

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

October 3, 2002

First Submitted That Met QC Criteria

October 3, 2002

First Posted (Estimate)

October 4, 2002

Study Record Updates

Last Update Posted (Estimate)

March 10, 2008

Last Update Submitted That Met QC Criteria

March 6, 2008

Last Verified

March 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 147
  • U01HL067972 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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