title: The Post-Myocardial Infarction Pacing Remodeling Prevention Therapy (PRomPT) Trial: Design and Rationale.
abstract: BACKGROUND
  Despite considerable improvements in the medical management of patients with myocardial infarction (MI), patients with large MI still have substantial risk of developing heart failure. In the early post-MI setting, implantable cardioverter defibrillators have reduced arrhythmic deaths but have no impact on overall mortality. Therefore, additional interventions are required to further reduce the overall morbidity and mortality of patients with large MI.
  
  
  METHODS
  The Pacing Remodeling Prevention Therapy (PRomPT) trial is designed to study the effects of peri-infarct pacing in preventing adverse post-MI remodeling. Up to 120 subjects with peak creatine phosphokinase >3,000 U/L (or troponin T >10 μg/L) at time of MI will be randomized to either dual-site or single-site biventricular pacing with the left ventricular lead implanted in a peri-infarct region or to a nonimplanted control group. Those randomized to a device will be blinded to the pacing mode, but randomization to a device or control cannot be blinded. Subjects randomized to pacing will have the device implanted within 10 days of MI. The primary objective is to assess the change in left ventricular end-diastolic volume from baseline to 18 months. Secondary objectives are to assess changes in clinical and mechanistic parameters between the groups, including rates of hospitalization for heart failure and cardiovascular events, the incidence of sudden cardiac death and all-cause mortality, New York Heart Association functional class, 6-minute walking distance, and quality of life.
  
  
  CONCLUSIONS
  The PRomPT trial will provide important evidence regarding the potential of peri-infarct pacing to interrupt adverse remodeling in patients with large MI.
authors: Heart and Vascular Center, Christ Hospital, Cincinnati, Ohio. Electronic address: chunge@ohioheart.org.
authors: Eugene S
authors: ES
authors: Chung
authors: Medtronic, Minneapolis, Minnesota.
authors: Trent M
authors: TM
authors: Fischer
authors: Medtronic, Minneapolis, Minnesota.
authors: Fred
authors: F
authors: Kueffer
authors: VA Medical Center, University of Minnesota, Minneapolis, Minnesota.
authors: Inder S
authors: IS
authors: Anand
authors: Leiden University Medical Center, Leiden, The Netherlands.
authors: Jeroen J
authors: JJ
authors: Bax
authors: Medical University of South Carolina, Charleston, South Carolina.
authors: Michael R
authors: MR
authors: Gold
authors: Gorman Cardiovascular Research Group, Perelman School of Medicine, University of Pennsylvania, Smilow Center for Translational Research, Philadelphia, Pennsylvania.
authors: Robert C
authors: RC
authors: Gorman
authors: Charité Universitätsmedizin, Berlin, Germany.
authors: Heinz
authors: H
authors: Theres
authors: Tufts University School of Medicine, Tufts Medical Center, Boston, Massachusetts.
authors: James E
authors: JE
authors: Udelson
authors: Department of Cardiology, Eastern Slovakia Institute for Cardiac and Vascular Diseases, Kosice, Slovakia.
authors: Branislav
authors: B
authors: Stancak
authors: Rigshospitalet, Copenhagen and University of Copenhagen, Copenhagen, Denmark.
authors: Jesper H
authors: JH
authors: Svendsen
authors: New York-Presbyterian Hospital, Columbia University Medical Center, New York, New York.
authors: Gregg W
authors: GW
authors: Stone
authors: Emory University Hospital Midtown, Emory University School of Medicine, Atlanta, Georgia.
authors: Angel
authors: A
authors: Leon
mesh_terms: D000328:Adult; D058406:Cardiac Resynchronization Therapy / Q000009:adverse effects / Q000379:methods / Q000401:mortality / Q000523:psychology; D003402:Creatine Kinase / Q000097:blood; D016757:Death, Sudden, Cardiac / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control; D004567:Electrodes, Implanted / Q000706:statistics & numerical data; D005080:Exercise Test / Q000295:instrumentation; D005260:Female; D006333:Heart Failure / Q000175:diagnosis / Q000209:etiology / Q000503:physiopathology / Q000517:prevention & control; D006352:Heart Ventricles / Q000473:pathology / Q000503:physiopathology / Q000601:surgery; D006760:Hospitalization / Q000706:statistics & numerical data; D006801:Humans; D008297:Male; D009203:Myocardial Infarction / Q000097:blood / Q000150:complications* / Q000175:diagnosis / Q000503:physiopathology; D011788:Quality of Life; D013318:Stroke Volume; D016896:Treatment Outcome; D020107:Troponin T / Q000097:blood; D020257:Ventricular Remodeling
chemical_list: D020107:Troponin T; D003402:Creatine Kinase
keywords: Myocardial infarction; adverse remodeling; heart failure; pacing