Myocardial Infarction, Sudden Death, Ventricular Dysfunction, Ventricular Fibrillation, Ventricular Tachycardia
Conditions
Keywords
myocardial infarction, acute, myocardial infarction, ventricular dysfunction, death, sudden, cardiac, death, sudden, death, ventricular tachycardia, ventricular fibrillation, defibrillation, electric, cardioversion, electric, electric countershock, defibrillators, external
Brief summary
This study explores the hypothesis that wearable defibrillators can impact mortality by reducing sudden death during the first three months after a heart attack in persons with high risk for life-threatening arrhythmias.
Detailed description
In patients with ventricular dysfunction immediately following myocardial infarction, sudden death may be responsible for up to 50% of total mortality. Wearable defibrillators may reduce sudden death by providing immediate detection and treatment of ventricular arrhythmias. This study is design to demonstrate a reduction in sudden death measured at three months following myocardial infarction among patients who have ventricular dysfunction.
Interventions
DEVICEwearable defibrillator
LifeVest wearable defibrillator
Sponsors
Zoll Medical Corporation
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients identified in the hospital or within 7 days after discharge with a diagnosis of an acute MI (STEMI or Non-STEMI) * LV ejection fraction ≤35% determined at the following time point: 1. If no PCI within the first 8 hours following the MI: ≥ 8 hours after MI 2. If acute PCI occurs within 8 hours of MI: ≥8 hours after PCI 3. If CABG is planned (before or within 7 days of discharge), wait to enroll and then use the most recent assessment at least 48 hours post CABG * Age ≥ 18 years
Exclusion criteria
* Existing ICD or indication for an ICD at the time of screening * Existing unipolar pacemakers/leads * Chronic renal failure requiring hemodialysis after hospital discharge * Chest circumference too small or too large for LifeVest garment\* * Participants discharged to an institutional setting with an anticipated stay \> 7 days * Pregnancy * Inability to consent * Any other condition or circumstance that in the judgment of the clinician makes the participant unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sudden Death Mortality | three months after myocardial infarction | For witnessed deaths, sudden cardiac death will be defined as an unexpected non-traumatic, non-self-inflicted fatality in otherwise stable participants who die within one hour of the onset of the terminal symptoms. For unwitnessed deaths, participants will meet the definition of sudden death if they are found dead within 24 hours of being well, assuming there is no evidence of another cause of death during that time period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All Cause Mortality | three months after myocardial infarction | All deaths, due to any cause |
| Compliance With Wearable Defibrillator Use | three months after myocardial infarction | daily wear time of the device |
Countries
Germany, Poland, United States
Participant flow
Recruitment details
From July 2008 through April 2017, the investigators enrolled 2348 participants at 76 sites in the United States, at 24 in Poland, at 6 in Germany, and at 2 in Hungary. One U.S. site was dismissed on June 24, 2014, and the 46 participants at that site were excluded from the analyses, due to irregularities found by the institutional review board at the site. Thus, a total of 2302 participants were included in the analyses (1524 participants in the device group and 778 in the control group).
Participants by arm
| Arm | Count |
|---|---|
| Wearable Defibrillator subjects in the Device Group will receive a LifeVest® wearable cardioverter-defibrillator (manufacturer: ZOLL Medical Corporation) plus guideline-directed medical therapy for post-myocardial infarction patients
wearable defibrillator: LifeVest wearable defibrillator | 1,524 |
| Conventional Treatment subjects in the Control Group will only receive guideline-directed medical therapy for post-myocardial infarction patients | 778 |
| Total | 2,302 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Participants Followed and Analyzed | Lost to Follow-up | 10 | 12 |
| Randominization | One site was dismissed due to IRB irregularity | 30 | 16 |
Baseline characteristics
| Characteristic | Wearable Defibrillator | Conventional Treatment | Total |
|---|---|---|---|
| Age, Continuous | 60.9 years STANDARD_DEVIATION 12.6 | 61.4 years STANDARD_DEVIATION 12.4 | 61.2 years STANDARD_DEVIATION 12.6 |
| Left ventricular ejection fraction | 28.2 percentage of total amount of blood STANDARD_DEVIATION 6.1 | 28.2 percentage of total amount of blood STANDARD_DEVIATION 5.8 | 28.2 percentage of total amount of blood STANDARD_DEVIATION 6.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 25 Participants | 12 Participants | 37 Participants |
| Race (NIH/OMB) Asian | 23 Participants | 14 Participants | 37 Participants |
| Race (NIH/OMB) Black or African American | 143 Participants | 75 Participants | 218 Participants |
| Race (NIH/OMB) More than one race | 20 Participants | 14 Participants | 34 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 33 Participants | 27 Participants | 60 Participants |
| Race (NIH/OMB) White | 1279 Participants | 636 Participants | 1915 Participants |
| Sex: Female, Male Female | 413 Participants | 195 Participants | 608 Participants |
| Sex: Female, Male Male | 1108 Participants | 577 Participants | 1685 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 48 / 1,524 | 38 / 778 |
| other Total, other adverse events | 1,421 / 1,524 | 714 / 778 |
| serious Total, serious adverse events | 475 / 1,524 | 253 / 778 |
Outcome results
Primary
Sudden Death Mortality
For witnessed deaths, sudden cardiac death will be defined as an unexpected non-traumatic, non-self-inflicted fatality in otherwise stable participants who die within one hour of the onset of the terminal symptoms. For unwitnessed deaths, participants will meet the definition of sudden death if they are found dead within 24 hours of being well, assuming there is no evidence of another cause of death during that time period.
Time frame: three months after myocardial infarction
Population: A total of 2302 participants were included in the analyses.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Wearable Defibrillator | Sudden Death Mortality | 25 Participants |
| Conventional Treatment | Sudden Death Mortality | 19 Participants |
Secondary
All Cause Mortality
All deaths, due to any cause
Time frame: three months after myocardial infarction
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Wearable Defibrillator | All Cause Mortality | 48 Participants |
| Conventional Treatment | All Cause Mortality | 38 Participants |
Secondary
Compliance With Wearable Defibrillator Use
daily wear time of the device
Time frame: three months after myocardial infarction
Population: Conventional treatment participants did not wear defibrillator.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Wearable Defibrillator | Compliance With Wearable Defibrillator Use | 18 hours per day |