Post-Myocardial Infarction Remodeling Prevention Therapy
NCT ID: NCT01213251
Last Updated: 2016-12-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
129 participants
INTERVENTIONAL
2010-12-31
2016-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Single Site Pacing
Single Site Pacing
Subjects will be implanted with a CRT-D that delivers pacing via the Left Ventricular lead.
Dual Site Pacing
Dual Site Pacing
Subjects will be implanted with a CRT-D that delivers pacing via the Left Ventricular and Right Ventricular lead.
Control
No interventions assigned to this group
Interventions
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Single Site Pacing
Subjects will be implanted with a CRT-D that delivers pacing via the Left Ventricular lead.
Dual Site Pacing
Subjects will be implanted with a CRT-D that delivers pacing via the Left Ventricular and Right Ventricular lead.
Eligibility Criteria
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Inclusion Criteria
* Peak Creatine Phosphokinase (CPK) greater than 3000 Units/Litre (U/L) at time of MI, or a troponin T (TnT) greater than 10 micrograms/Litre (mcg/L)
* At least 18 years old
* Willing to comply with the protocol
Exclusion Criteria
* Chronic renal disease, as defined by estimated glomerular filtration rate (eGFR) less than 30 milliliters/minute/1.73 square meter
* Life expectancy less than 18 months, as determined by a physician
* Existing pacemaker, Implantable Cardioverter Defibrillator (ICD), or Cardiac Resynchronization Therapy (CRT) device
* QRS duration greater than 120 milliseconds (ms)
* Coronary Artery Bypass Graft (CABG) within 30 days prior to MI, or CABG procedure planned
* Third degree atrioventricular (AV) block or symptomatic bradyarrhythmia
* Persistent atrial fibrillation (AF) that is not self terminating within 7 days or is terminated electrically or pharmacologically
* Permanent AF that is non self terminating, with cardioversion failed or not attempted within the past year
* New York Heart Association (NYHA) Class IV
* Non-ischemic cardiomyopathy
* Pregnant or planning to become pregnant during the study
* Enrolled or planning to participate in a concurrent drug and/or device study during the course of this clinical trial. Co-enrollment in concurrent trials is only allowed with documented pre-approval from Medtronic, documenting that there is not a concern that co-enrollment could confound the results of this trial.
* Breast feeding
* Of a vulnerable population as determined by local law or requirement, or a physician
18 Years
ALL
No
Sponsors
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Medtronic Cardiac Rhythm and Heart Failure
INDUSTRY
Responsible Party
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Principal Investigators
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Gregg Stone, MD
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Angel Leon, MD
Role: PRINCIPAL_INVESTIGATOR
Emory University
Locations
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Arizona Arrhythmia Consultants
Scottsdale, Arizona, United States
Kaiser Permanente
Los Angeles, California, United States
Emory University Hospital Midtown
Atlanta, Georgia, United States
Lexington Cardiac Research Foundation
Lexington, Kentucky, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Michigan Heart, PC
Ypsilanti, Michigan, United States
Carolina Heart Specialists
Gastonia, North Carolina, United States
Lindner Clinical Trial Center
Cincinnati, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
The Chattanooga Heart Institute
Chattanooga, Tennessee, United States
The Stern Cardiovascular Foundation
Germantown, Tennessee, United States
Saint Thomas Research Institute, LLC
Nashville, Tennessee, United States
Baylor Jack and Jane Hamilton Heart and Vascular Hospital
Dallas, Texas, United States
Delgado Cardiovascular Associates
Houston, Texas, United States
Spokane Cardiology
Spokane, Washington, United States
Rigshospitalet
Copenhagen, , Denmark
Hôpital Cardiologique du Haut-Lévêque
Bordeaux-Pessac, , France
Centre Hospitalier Régional Universitaire de Lille
Lille, , France
Herzzentrum Leipzig GmbH
Leipzig, , Germany
University Hospital Mannheim
Mannheim, , Germany
Maygar Honvédség Honvédkorház
Budapest, , Hungary
Semmelweis University Heart Center
Budapest, , Hungary
Prince Salman Heart Centre
King Fahad Medical City, , Saudi Arabia
Vychodoslovensky ustav srdcovych a cievnych chorob, a.s.
Košice, , Slovakia
Countries
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References
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Stone GW, Chung ES, Stancak B, Svendsen JH, Fischer TM, Kueffer F, Ryan T, Bax J, Leon A; PRomPT Trial Investigators. Peri-infarct zone pacing to prevent adverse left ventricular remodelling in patients with large myocardial infarction. Eur Heart J. 2016 Feb 1;37(5):484-93. doi: 10.1093/eurheartj/ehv436. Epub 2015 Aug 30.
Related Links
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The Post-Myocardial Infarction Pacing Remodeling Prevention Therapy (PRomPT) Trial: Design and Rationale
Other Identifiers
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PRomPT
Identifier Type: -
Identifier Source: org_study_id