Post-Myocardial Infarction Remodeling Prevention Therapy - Full Text View

Purpose

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.

Condition	Intervention	Phase
Acute Myocardial Infarction Pacing Therapy Cardiac Remodeling Heart Failure	Device: Single Site Pacing Device: Dual Site Pacing	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	Post-Myocardial Infarction Remodeling Prevention Therapy

Resource links provided by NLM:

MedlinePlus related topics: Heart Attack Heart Failure

U.S. FDA Resources

Further study details as provided by Medtronic Cardiac Rhythm Disease Management:

Primary Outcome Measures:

Change in left ventricular end diastolic volume (LVEDV) [ Time Frame: Baseline - 18 Month Follow Up Visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety of implanting a Cardiac Resynchronization Therapy with Defibrillator (CRT-D) device within 10 days of myocardial infarction (MI), as measured by the rate of reported adverse events [ Time Frame: Baseline - 18 Month Follow Up Visit ] [ Designated as safety issue: No ]
Frequency of hospitalization for heart failure and cardiovascular events [ Time Frame: Baseline - 18 Month Follow Up Visit ] [ Designated as safety issue: No ]
Change in New York Heart Association (NYHA) functional class [ Time Frame: Baseline - 18 Month Follow Up Visit ] [ Designated as safety issue: No ]
Change in 6-minute walk test distance [ Time Frame: Baseline - 18 Month Follow Up Visit ] [ Designated as safety issue: No ]
Change in quality of life [ Time Frame: Baseline - 18 Month Follow Up Visit ] [ Designated as safety issue: No ]
Incidence of sudden cardiac death and total mortality [ Time Frame: Baseline - 18 Month Follow Up Visit ] [ Designated as safety issue: No ]
Association between clinical characteristics; including peak creatinine phosphokinase (CPK), peak troponin, lead location, time from MI onset to implant, and change in LV volumes. [ Time Frame: Baseline - 18 Month Follow Up Visit ] [ Designated as safety issue: No ]

Estimated Enrollment:	250
Study Start Date:	December 2010
Estimated Study Completion Date:	October 2014
Estimated Primary Completion Date:	October 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Single Site Pacing	Device: Single Site Pacing Subjects will be implanted with a CRT-D that delivers pacing via the Left Ventricular lead.
Experimental: Dual Site Pacing	Device: Dual Site Pacing Subjects will be implanted with a CRT-D that delivers pacing via the Left Ventricular and Right Ventricular lead.
No Intervention: Control

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

MI within the past 10 days
Peak 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:

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
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01213251

Contacts

Contact: Jennifer Heim	(763) 526-3553	rs.prompt@medtronic.com
Contact: Marina Ostanniy	(763) 526-9751	rs.prompt@medtronic.com

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Locations

United States, Arizona
Arizona Arrhythmia Consultants	Recruiting
Scottsdale, Arizona, United States, 85251
United States, California
Kaiser Permanente	Recruiting
Los Angeles, California, United States, 90027
United States, Georgia
Emory University Hospital Midtown	Recruiting
Atlanta, Georgia, United States, 30308
United States, Kentucky
Lexington Cardiac Research Foundation	Recruiting
Lexington, Kentucky, United States, 40503
United States, Massachusetts
Massachusetts General Hospital	Recruiting
Boston, Massachusetts, United States, 02114
United States, Michigan
Michigan Heart, PC	Recruiting
Ypsilanti, Michigan, United States, 48197
United States, North Carolina
Carolina Heart Specialists	Recruiting
Gastonia, North Carolina, United States, 28054
United States, Ohio
Lindner Clinical Trial Center	Recruiting
Cincinnati, Ohio, United States, 45219
Cleveland Clinic Foundation	Recruiting
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Hospital of the University of Pennsylvania	Recruiting
Philadelphia, Pennsylvania, United States, 19104
University of Pittsburgh Medical Center	Recruiting
Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
The Chattanooga Heart Institute	Recruiting
Chattanooga, Tennessee, United States, 37404
The Stern Cardiovascular Foundation	Recruiting
Germantown, Tennessee, United States, 38138
Saint Thomas Research Institute, LLC	Recruiting
Nashville, Tennessee, United States, 37205
United States, Texas
Baylor Jack and Jane Hamilton Heart and Vascular Hospital	Recruiting
Dallas, Texas, United States, 75226
Delgado Cardiovascular Associates	Recruiting
Houston, Texas, United States, 77004
United States, Washington
Spokane Cardiology	Recruiting
Spokane, Washington, United States, 99204
Denmark
Århus Universitetshospital Skejby	Withdrawn
Aarhus, Denmark
Rigshospitalet	Recruiting
Copenhagen, Denmark
France
Hôpital Cardiologique du Haut-Lévêque	Recruiting
Bordeaux-Pessac, France
Centre Hospitalier Régional Universitaire de Lille	Recruiting
Lille, France
Germany
Herzzentrum Leipzig GmbH	Recruiting
Leipzig, Germany
University Hospital Mannheim	Recruiting
Mannheim, Germany
Hungary
Semmelweis University Heart Center	Recruiting
Budapest, Hungary
Maygar Honvédség Honvédkorház	Recruiting
Budapest, Hungary
Saudi Arabia
Prince Salman Heart Centre	Recruiting
King Fahad Medical City, Saudi Arabia
Slovakia
Vychodoslovensky ustav srdcovych a cievnych chorob, a.s.	Recruiting
Kosice, Slovakia

Sponsors and Collaborators

Medtronic Cardiac Rhythm Disease Management

Investigators

Principal Investigator:	Gregg Stone, MD	Columbia University
Principal Investigator:	Angel Leon, MD	Emory University

More Information

No publications provided

Responsible Party:	Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:	NCT01213251 History of Changes
Other Study ID Numbers:	PRomPT
Study First Received:	September 28, 2010
Last Updated:	May 8, 2013
Health Authority:	United States: Food and Drug Administration Denmark: Danish Medicines Agency Slovakia: State Institute for Drug Control Saudi Arabia: No oversight authority approval required France:French Agency for the Safety of Health Products Hungary:Office of Health Authorization and Administrative Procedures Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:

Heart Failure
Infarction
Myocardial Infarction
Heart Diseases
Cardiovascular Diseases

Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Vascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013

Post-Myocardial Infarction Remodeling Prevention Therapy (PRomPT)