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.
Brief Title
Vest Prevention of Early Sudden Death Trial and VEST Registry
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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Myocardial Infarction
Ventricular Dysfunction
Sudden Death
Ventricular Tachycardia
Ventricular Fibrillation
Eligibility Criteria
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.
* 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.
Inclusion Criteria
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
* 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
Gender
All
Gender Based
false
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
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT01446965
Org Class
Other
Org Full Name
University of California, San Francisco
Org Study Id
90D0114
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Vest Prevention of Early Sudden Death Trial: Prevention of Sudden Death After Myocardial Infarction Using a LifeVest Wearable Cardioverter-defibrillator (Formerly VEST/PREDICTS)
Primary Outcomes
Outcome Description
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.
Outcome Measure
Sudden Death Mortality
Outcome Time Frame
three months after myocardial infarction
Secondary Outcomes
Outcome Description
All deaths, due to any cause
Outcome Time Frame
three months after myocardial infarction
Outcome Measure
All Cause Mortality
Outcome Description
daily wear time of the device
Outcome Time Frame
three months after myocardial infarction
Outcome Measure
Compliance With Wearable Defibrillator Use
See Also Links
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Jay Gross
Investigator Email
jagross@montefiore.org
Investigator Phone
Categories Mesh Debug
Heart/Cardiovascular --- MYOCARDIAL INFARCTION
Heart/Cardiovascular --- MYOCARDIAL ISCHEMIA
Brain, Spinal Cord & Nervous System --- HEART DISEASES
Heart/Cardiovascular --- HEART DISEASES
Blood Disorders --- CARDIOVASCULAR DISEASES
Blood & Bone Marrow Cancers --- CARDIOVASCULAR DISEASES
Heart/Cardiovascular --- CARDIOVASCULAR DISEASES
Blood & Bone Marrow Cancers --- VASCULAR DISEASES
Heart/Cardiovascular --- VASCULAR DISEASES
Heart/Cardiovascular --- INFARCTION
Heart/Cardiovascular --- ISCHEMIA
Heart/Cardiovascular --- ARRHYTHMIAS, CARDIAC
MeSH Terms
MYOCARDIAL INFARCTION
VENTRICULAR DYSFUNCTION
DEATH, SUDDEN
TACHYCARDIA, VENTRICULAR
VENTRICULAR FIBRILLATION
DEATH, SUDDEN, CARDIAC
DEATH
MYOCARDIAL ISCHEMIA
HEART DISEASES
CARDIOVASCULAR DISEASES
VASCULAR DISEASES
INFARCTION
ISCHEMIA
PATHOLOGIC PROCESSES
PATHOLOGICAL CONDITIONS, SIGNS AND SYMPTOMS
NECROSIS
TACHYCARDIA
ARRHYTHMIAS, CARDIAC
CARDIAC CONDUCTION SYSTEM DISEASE
HEART ARREST