Post-Myocardial Infarction Remodeling Prevention Therapy

Completed · Phase 2

Conditions studied: Acute Myocardial Infarction, Pacing Therapy, Cardiac Remodeling, Heart Failure

In brief

The purpose of this study is to demonstrate the feasibility of pacing as a therapy to prevent adverse remodeling of the myocardium following an acute myocardial infarction (MI) in patients at highest risk for adverse myocardial remodeling.

Key facts

Study ID

NCT01213251

Run by

Medtronic Cardiac Rhythm and Heart Failure

People needed

129

Starts

2010-12-01

Expected to finish

2016-04-01

Last updated by the study team

2016-12-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Myocardial Infarction (MI) within the past 10 days
• 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

You may not qualify if…

• Documented MI greater than 10 days
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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