Clinical trial NCT01446965: Vest Prevention of Early Sudden Death Trial and VEST Registry
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myocardial Infarction
Ventricular Dysfunction
Sudden Death
Ventricular Tachycardia
Ventricular Fibrillation
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
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Zoll Medical Corporation
First posted: 2011-10-05
Enrollment: 2348
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Sudden Death Mortality
timeFrame: three months after myocardial infarction
Secondary outcomes:
measure: All Cause Mortality
timeFrame: three months after myocardial infarction
measure: Compliance With Wearable Defibrillator Use
timeFrame: three months after myocardial infarction
Other outcomes:
Locations:
city: Anchorage
country: United States
facility: Alaska Heart Institute
state: Alaska
city: Fresno
country: United States
facility: Cardiovascular Consultants Heart Center
state: California
city: Salinas
country: United States
facility: Salinas Valley Memorial Healthcare System
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: Newark
country: United States
facility: Christiana Care Health Services
state: Delaware
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Lakeland
country: United States
facility: Watson Clinic for Research, Inc.
state: Florida
city: Melbourne
country: United States
facility: Melbourne Cardiac Resarch Institute
state: Florida
city: Orlando
country: United States
facility: Florida Heart Group/Florida Hospital
state: Florida
city: Oak Lawn
country: United States
facility: Advocate Christ Hospital
state: Illinois
city: Park Ridge
country: United States
facility: Lutheran General
state: Illinois
city: Evansville
country: United States
facility: The Heart Group/Deaconess Hospital
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Indianapolis
country: United States
facility: St. Vincent Medical Group
state: Indiana
city: Bowling Green
country: United States
facility: Western Kentucky Heart and Lung
state: Kentucky
city: Lexington
country: United States
facility: University of Kentucky Gill Heart Institute
state: Kentucky
city: New Orleans
country: United States
facility: Ochsner Clinic
state: Louisiana
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts Memorial
state: Massachusetts
city: Ridgewood
country: United States
facility: The Valley Hospital
state: New Jersey
city: Albuquerque
country: United States
facility: Presbyterian Heart Group
state: New Mexico
city: Albany
country: United States
facility: Albany Associates in Cardiology
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Johnson City
country: United States
facility: United Health Services
state: New York
city: New Hyde Park
country: United States
facility: Long Island Jewish Hospital
state: New York
city: New York
country: United States
facility: St. Luke's- Roosevelt Hospital Center
state: New York
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: New York
country: United States
facility: Lenox Hill Hospital
state: New York
city: New York
country: United States
facility: Huntington Hospital
state: New York
city: Rochester
country: United States
facility: University Cardiovascular Associates (Rochester)
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina @ Chapel Hill
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Raleigh
country: United States
facility: Wake Heart Research
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: University Hospital Case Medical Center
state: Ohio
city: Elyria
country: United States
facility: North Ohio Heart Center-North Ohio Research
state: Ohio
city: Toledo
country: United States
facility: Cardiovascular Research Center, LLC/Mercy St Vincent
state: Ohio
city: Tulsa
country: United States
facility: Oklahoma Heart Institute-Hillcrest
state: Oklahoma
city: Springfield
country: United States
facility: Oregon Heart & Vascular
state: Oregon
city: Chambersburg
country: United States
facility: Chambersburg Hospital
state: Pennsylvania
city: Danville
country: United States
facility: Geisinger Heart Institute
state: Pennsylvania
city: Sayre
country: United States
facility: The Guthrie Clinic/Guthrie Medical Group
state: Pennsylvania
city: Providence
country: United States
facility: Brown Medical School-Rhode Island Hospital
state: Rhode Island
city: Columbia
country: United States
facility: Providence/South Carolina Heart Center
state: South Carolina
city: Florence
country: United States
facility: McLeod Health/Pee Dee Cardiology
state: South Carolina
city: Kingsport
country: United States
facility: Wellmont Holston Valley
state: Tennessee
city: Knoxville
country: United States
facility: Turkey Creek Medical Center
state: Tennessee
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Roanoke
country: United States
facility: Carilion Clinic
state: Virginia
city: Tacoma
country: United States
facility: Cardiac Study Center
state: Washington
city: Heidelberg
country: Germany
facility: Med. Uniklinik Heidelberg
state: Deutschland
city: Duisburg
country: Germany
facility: Herzzentrum Duisburg Kaiser-Wilhelm-Krankenhaus
state: Nordrhein-Westfalen
city: Bremen
country: Germany
facility: Klinikum Links der Weser gGmbh Klinik
city: Göttingen
country: Germany
facility: Klinikum Göttingen Georg-August-Universität Göttingen
city: Ludwigshafen
country: Germany
facility: Klinikum der Stadt Ludwigshafen
city: Mainz
country: Germany
facility: UNIVERSITÄTSMEDIZIN der Johannes Gutenberg-Universität Mainz
city: Mannheim
country: Germany
facility: Universitätsklinikum Mannheim
city: Gdansk
country: Poland
facility: Gdanski Uniwersytet Medyczny
city: Kielce
country: Poland
facility: Specjalistyczna Poradnia Kardiologiczna
city: Lodz
country: Poland
facility: Mc Tronik
city: Rzeszow
country: Poland
facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Ministerstwa Spraw Wewnetrznych w Rzeszowie
city: Warsaw
country: Poland
facility: II Klinika Choroby Wiencowej, Instytut Kardiologii (Institute of Cardiology, Clinic II)
city: Warsaw
country: Poland
facility: Medical University of Warsaw
city: Warszawa
country: Poland
facility: Institute of Cardiology
Study officials:
affiliation: University of California, San Francisco
name: Jeffrey E Olgin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Byron K Lee, MD
role: STUDY_DIRECTOR
affiliation: University of California, San Francisco
name: Mark J Pletcher, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Olgin JE, Pletcher MJ, Vittinghoff E, Wranicz J, Malik R, Morin DP, Zweibel S, Buxton AE, Elayi CS, Chung EH, Rashba E, Borggrefe M, Hue TF, Maguire C, Lin F, Simon JA, Hulley S, Lee BK; VEST Investigators. Wearable Cardioverter-Defibrillator after Myocardial Infarction. N Engl J Med. 2018 Sep 27;379(13):1205-1215. doi: 10.1056/NEJMoa1800781.