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

National Institutes of Health (NIH)

Status and phase: Completed; Phase 3

Conditions: Myocardial Infarction; Cardiovascular Diseases; Heart Diseases; Death, Sudden, Cardiac

Treatments: Device: Automatic External Defibrillation; Other: Cardiopulmonary Resuscitation

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT00047411

U01HL067972 (U.S. NIH Grant/Contract)

147

Details and patient eligibility

About

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.

Full 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.

Enrollment: 7,001 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

7,001 participants in 2 patient groups

1

Active Comparator group

Description:

Intervention: Immediate notification of EMS by telephone and prompt initiation of CPR, in accordance with published Basic Life Support guidelines.

Treatment:

Other: Cardiopulmonary Resuscitation

2

Experimental group

Description:

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.

Treatment:

Device: Automatic External Defibrillation