Cardiovascular DiseasesPhase 3HATNCT00047411
Home Use of Automatic External Defibrillators to Treat Sudden Cardiac Arrest
A Phase 3 study testing Cardiopulmonary Resuscitation and Automatic External Defibrillation in people with Cardiovascular Diseases and Myocardial Infarction, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases, Myocardial Infarction, Heart Diseases
- What is being tested?
- Cardiopulmonary Resuscitation and Automatic External Defibrillation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,001 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2002to Sep 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of anterior myocardial infarction
- Live-in spouse or companion willing to administer CPR or AED therapy plus CPR
Who cannot join
- Existing implantable cardiac defibrillator or AED
- Current candidate for an implantable cardiac defibrillator
- Current "Do Not Resuscitate" orders
Trial locations and contacts
1 site in 1 country.
United States1 site
Seattle Institute for Cardiac Research
Seattle, Washington, 98103
About this study
Official title: 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.
Read the 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.
- Being tested
- Cardiopulmonary Resuscitation, Automatic External Defibrillation
- Keywords
- CPR, AED
- Medical subject headings
- Cardiovascular Diseases, Myocardial Infarction, Heart Diseases, Death, Sudden, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiopulmonary ResuscitationOther
Immediate notification of EMS by telephone and prompt initiation of CPR, in accordance with published Basic Life Support guidelines
Automatic External DefibrillationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Intervention: Immediate notification of EMS by telephone and prompt initiation of CPR, in accordance with published Basic Life Support guidelines. Receives: Other: Cardiopulmonary Resuscitation |
| 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. Receives: Device: Automatic External Defibrillation |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality (measured throughout the study)
Measured: Five interim analyses of the data were performed and reviewed by the DSMB
Secondary outcomes (2)
Survival in the home from cardiac arrest and survival with AED use.
Measured: 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)
Measured: Five interim analyses of the data were performed and reviewed by the DSMB
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2002 (estimated)
- Study startSep 2002
- Primary completionSep 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7,001 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Philips Medical Systems, Laerdal Medical
- Investigators
- Gust H. Bardy, Study chair, Seattle Institute for Cardiac Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00047411
- Sponsor's protocol ID
- 147
- Other IDs
- U01HL067972
- Acronym
- HAT
- Status last verified
- Mar 2008
- First submitted
- 3 Oct 2002
- Last updated
- 10 Mar 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mark DB, Anstrom KJ, McNulty SE, Flaker GC, Tonkin AM, Smith WM, Toff WD, Dorian P, Clapp-Channing NE, Anderson J, Johnson G, Schron EB, Poole JE, Lee KL, Bardy GH. Quality of life effects of automatic external defibrillators in the home: results from the Home Automatic External Defibrillator Trial (HAT). Am Heart J. 2010 Apr;159(4):627-634.e7. doi: 10.1016/j.ahj.2010.01.013.
PubMed 20362722Bardy GH, Lee KL, Mark DB, Poole JE, Toff WD, Tonkin AM, Smith W, Dorian P, Packer DL, White RD, Longstreth WT Jr, Anderson J, Johnson G, Bischoff E, Yallop JJ, McNulty S, Ray LD, Clapp-Channing NE, Rosenberg Y, Schron EB; HAT Investigators. Home use of automated external defibrillators for sudden cardiac arrest. N Engl J Med. 2008 Apr 24;358(17):1793-804. doi: 10.1056/NEJMoa0801651. Epub 2008 Apr 1.
PubMed 18381485
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Automatic External Defibrillator Trial -- HAT
- ClinicalTrials.gov ID
- NCT00047411
- Acronym / sponsor ID
- HAT / 147
- Keywords
- CPR, AED
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7,001 participants (estimated)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Collaborators
- Philips Medical Systems, Laerdal Medical
- Study start
- Sep 2002
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 4 Oct 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Other: Cardiopulmonary ResuscitationIntervention: Immediate notification of EMS by telephone and prompt initiation of CPR, in accordance with published Basic Life Support guidelines. |
| 2 | Experimental | Device: Automatic External DefibrillationUse 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- History of anterior myocardial infarction
- Live-in spouse or companion willing to administer CPR or AED therapy plus CPR
Key exclusion criteria (3 listed)
- Existing implantable cardiac defibrillator or AED
- Current candidate for an implantable cardiac defibrillator
- Current "Do Not Resuscitate" orders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiopulmonary ResuscitationImmediate notification of EMS by telephone and prompt initiation of CPR, in accordance with published Basic Life Support guidelines | Other | 1 |
| Automatic External DefibrillationUse 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 | 2 |
Primary outcome
All-cause mortality (measured throughout the study)
Time frame: Five interim analyses of the data were performed and reviewed by the DSMB
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2008.
- Derived from this study: PubMed 20362722Mark DB, Anstrom KJ, McNulty SE, Flaker GC, Tonkin AM, Smith WM, Toff WD, Dorian P, Clapp-Channing NE, Anderson J, Johnson G, Schron EB, Poole JE, Lee KL, Bardy GH. Quality of life effects of automatic external defibrillators in the home: results from the Home Automatic External Defibrillator Trial (HAT). Am Heart J. 2010 Apr;159(4):627-634.e7. doi: 10.1016/j.ahj.2010.01.013.
- Derived from this study: PubMed 18381485Bardy GH, Lee KL, Mark DB, Poole JE, Toff WD, Tonkin AM, Smith W, Dorian P, Packer DL, White RD, Longstreth WT Jr, Anderson J, Johnson G, Bischoff E, Yallop JJ, McNulty S, Ray LD, Clapp-Channing NE, Rosenberg Y, Schron EB; HAT Investigators. Home use of automated external defibrillators for sudden cardiac arrest. N Engl J Med. 2008 Apr 24;358(17):1793-804. doi: 10.1056/NEJMoa0801651. Epub 2008 Apr 1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gust H. Bardy study chair
Seattle Institute for Cardiac Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cardiopulmonary Resuscitation and Automatic External Defibrillation in people with Cardiovascular Diseases and Myocardial Infarction, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (measured throughout the study) (time frame: Five interim analyses of the data were performed and reviewed by the DSMB). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00047411, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2008.