ST Monitoring to Detect Acute Coronary Syndrome Events in Implantable Cardioverter Defibrillator Patients
NCT ID: NCT01424722
Last Updated: 2021-01-28
Study Results
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View full resultsBasic Information
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TERMINATED
NA
2258 participants
INTERVENTIONAL
2011-08-31
2017-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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ST Monitoring Feature
ST segment continous monitoring feature enabled and programmed ON
Fortify® ST, Fortify Assura® ST, Ellipse® ST family of devices
Algorithm for detecting ST changes that may be indicative of an acute coronary syndrome.
Interventions
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Fortify® ST, Fortify Assura® ST, Ellipse® ST family of devices
Algorithm for detecting ST changes that may be indicative of an acute coronary syndrome.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Have an indication for an ICD implantation or pulse generator change
2. Have documented coronary artery disease. Documented coronary artery disease is defined as having at least one of the following present a) evidence of a prior MI on ECG and/or cardiac enzymes, b) prior revascularization (by coronary artery bypass grafting or percutaneous coronary intervention) c) angina and/or ST-T wave abnormalities indicative of ischemia on exercise stress test, nuclear stress test, or echo stress test, or d) coronary artery disease diagnosed by coronary angiography.
3. Willing and able to comply with protocol requirements, including keeping all required visits
4. Willing to participate in the study and able to sign an IRB approved informed consent form
5. Be at least 18 years of age when enrolled in the study
Exclusion Criteria
1. Are pacemaker dependent (defined as a need for ventricular pacing ≥ 20% of the time)
2. Have NYHA Class IV Heart Failure
3. Have persistent or permanent atrial fibrillation
4. Have a known history of intermittent Bundle Branch Block
5. Pregnant or planning a pregnancy during the study participation
6. Have a life expectancy of \< 1 year due to any condition
7. Are currently participating in a clinical investigation that includes an active treatment arm.
18 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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Principal Investigators
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Michael Gibson, MD
Role: PRINCIPAL_INVESTIGATOR
Boston Clinical Research Institute
Locations
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Cardiovascular Associates PC
Birmingham, Alabama, United States
Cardiovascular Associates PC
Birmingham, Alabama, United States
University Hospital - Univ. of Alabama at Birmingham (UAB)
Birmingham, Alabama, United States
Heart Center Research, LLC
Huntsville, Alabama, United States
Banner Heart Hospital
Mesa, Arizona, United States
Arizona Arrhythmia Research Center
Phoenix, Arizona, United States
Carondelet Specialist Group - Southwest Heartr
Tucson, Arizona, United States
Arkansas Cardiology
Little Rock, Arkansas, United States
Arkansas Heart Hospital
Little Rock, Arkansas, United States
Central Cardiology
Bakersfield, California, United States
John Muir Medical Center
Concord, California, United States
St. Jude Hospital
Fullerton, California, United States
Cardia Care Specialists
Glendale, California, United States
Glendale Memorial Hospital and Medical Center
Glendale, California, United States
Scripps Memorial Hospital La Jolla
La Jolla, California, United States
Long Beach Memorial
Long Beach, California, United States
Kaiser Permanente Los Angeles
Los Angeles, California, United States
USC University Hospital
Los Angeles, California, United States
Cardiac Rhythm Specialists, Inc.
Northridge, California, United States
Sutter Memorial Hospital
Sacramento, California, United States
Colorado Cardiac Alliance
Colorado Springs, Colorado, United States
Cardiology Associates of Fairfield County
Norwalk, Connecticut, United States
Christiana Hospital
Newark, Delaware, United States
Washington Hospital Center
Washington D.C., District of Columbia, United States
Manatee Memorial Hospital
Bradenton, Florida, United States
Cardiology Consultants PA
Daytona Beach, Florida, United States
Holy Cross Hospital
Fort Lauderdale, Florida, United States
First Coast Cardiovascular Institute
Jacksonville, Florida, United States
Watson Clinic Center
Lakeland, Florida, United States
University of Miami Hospital
Miami, Florida, United States
Munroe Regional Medical Center
Ocala, Florida, United States
Florida Hospital Orlando
Orlando, Florida, United States
Athens Regional Medical Center
Athens, Georgia, United States
Northeast Georgia Heart Center, PC
Gainesville, Georgia, United States
Redmond Regional Medical Center
Rome, Georgia, United States
The Queen's Medical Center
Honolulu, Hawaii, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
Northern Indiana Research Alliance
Fort Wayne, Indiana, United States
Iowa Heart Center
West Des Moines, Iowa, United States
Mid-America Cardiology Associates, PC
Kansas City, Kansas, United States
Kentucky Heart Institute / King's Daughter
Ashland, Kentucky, United States
Central Baptist Hospital
Lexington, Kentucky, United States
University of Louisville
Louisville, Kentucky, United States
Heart Clinic of Hammond
Hammond, Louisiana, United States
Ochsner Medical Center
New Orleans, Louisiana, United States
MedStar Research Institute
Baltimore, Maryland, United States
Shady Grove Adventist Hospital
Rockville, Maryland, United States
University of Massachusettts Medical Center
Worcester, Massachusetts, United States
Thoracic Cardiovascular Healthcare Foundation
Lansing, Michigan, United States
Providence Hospital
Southfield, Michigan, United States
Munson Medical Center
Traverse City, Michigan, United States
VA Medical Center Minneapolis
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Jackson Heart Clinic
Jackson, Mississippi, United States
North Kansas City Hospital
North Kansas City, Missouri, United States
Mercy Medical Research Institute
Springfield, Missouri, United States
Mercy Hospital St. Louis
St Louis, Missouri, United States
Deborah Heart and Lung Center
Browns Mills, New Jersey, United States
Lourdes Cardiology Services
Cherry Hill, New Jersey, United States
Englewood Hospital & Medical Center
Englewood, New Jersey, United States
Cardiovascular Associates of the Delaware Valley
Haddon Heights, New Jersey, United States
New Mexico Heart Institute
Albuquerque, New Mexico, United States
Southwest Heart PC
Las Cruces, New Mexico, United States
Buffalo Heart Group
Buffalo, New York, United States
Stony Brook Medical Center
Stony Brook, New York, United States
LeBauer Cardiovascular Research Foundation
Greensboro, North Carolina, United States
Forsyth Medical Center
Winston-Salem, North Carolina, United States
Northeast Ohio Cardiovascular Associates
Akron, Ohio, United States
University Hospitals of Cleveland
Cleveland, Ohio, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
Ohio State Univeristy
Columbus, Ohio, United States
Ohio Health Research Institute
Columbus, Ohio, United States
EMH Regional Medical Center
Elyria, Ohio, United States
University of Toledo Medical Center
Toledo, Ohio, United States
Oklahoma Heart Institute at Utica
Tulsa, Oklahoma, United States
Capital Cardiovascular Associates
Camp Hill, Pennsylvania, United States
Penn State Milton Hershey Medical Center
Hershey, Pennsylvania, United States
Allegheny-Singer Research Institute
Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Donald Guthrie Foundation for Education and Research
Sayre, Pennsylvania, United States
Columbia Cardiology Consultants
Columbia, South Carolina, United States
Upstate Cardiology
Greenville, South Carolina, United States
Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States
Cardiology Consultants
Johnson City, Tennessee, United States
Methodist University Hospital
Memphis, Tennessee, United States
St. Thomas Hospital Heart
Nashville, Tennessee, United States
Vanderbilt Medical Center
Nashville, Tennessee, United States
Cardiology Center of Amarillo, LLP
Amarillo, Texas, United States
VA Medical Center Dallas
Dallas, Texas, United States
South Texas Cardiovascular Consultants
San Antonio, Texas, United States
Scott & White Memorial Hospital
Temple, Texas, United States
Cardiovascular Associates of East Texas
Tyler, Texas, United States
McKay-Dee Heart Services
Ogden, Utah, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
Hunter Holmes McGuire VAMC
Richmond, Virginia, United States
The Hope Heart Institute
Bellevue, Washington, United States
The Heart Institute at Virginia Mason
Seattle, Washington, United States
Countries
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Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Document Type: Informed Consent Form
Other Identifiers
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CRD_420
Identifier Type: -
Identifier Source: org_study_id
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