Try our beta test site

Post-Myocardial Infarction Remodeling Prevention Therapy (PRomPT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov Identifier:
NCT01213251
First received: September 28, 2010
Last updated: October 21, 2016
Last verified: October 2016
  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
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:


Further study details as provided by Medtronic Cardiac Rhythm and Heart Failure:

Primary Outcome Measures:
  • Change in Left Ventricular End Diastolic Volume (LVEDV) [ Time Frame: Baseline - 18 Month Follow Up Visit ]

    Left ventricular end diastolic volume (LVEDV) was measured by echocardiogram. Change was measured as Month 18 LVEDV minus baseline LVEDV.

    Per protocol, change in LVEDV is compared between Pooled Pacing (Single site + Dual Site) and Control.



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: 18 months post-implant ]
    Survival estimates at 18 months post-implant for time to first following events: (a) System Related Adverse Event (b) System Related Complication (c) Procedure Related Adverse Event (d) Procedure Related Complication and (e) System Related or Procedure Related Complication.

  • Frequency of Hospitalization for Cardiovascular Events [ Time Frame: Baseline - 18 Month Follow Up Visit ]
    Number of hospitalizations related to cardiovascular events.

  • Change in New York Heart Association (NYHA) Functional Class [ Time Frame: Baseline - 18 Month Follow Up Visit ]

    The New York Heart Association (NYHA) score classifies patients' heart failure according to the severity of their symptoms. In particular, Class I: No limitation of physical activity. Class II: Slight limitation of physical activity. Class III: Marked limitation of physical activity. Class IV: Unable to carry on any physical activity without discomfort.

    NYHA change from baseline to 18-month visit. If a subject improved by one NYHA class or more (e.g. NYHA IV to NYHA II, or NYHA III to NYHA I, etc) from the baseline visit, the subject was classified as "Improved". Similarly for "Worsened" (e.g. subject does not have heart failure to NYHA I, NYHA I to NYHA II, etc.). If the subjects' NYHA Class is not different than baseline, then the subject was classified as "No Change".

    Per protocol, change in NYHA is compared between Pooled Pacing (Single site + Dual Site) and Control.


  • Change in 6-minute Walk Test Distance [ Time Frame: 1 Month - 18 Month Follow Up Visit ]

    Change in 6-minute hallwalk distance from 1-month visit to the 18-month visit.

    Change is defined as month 18 minus baseline.

    Per protocol, change in 6-minute walk test distance is compared between Pooled Pacing (Single site + Dual Site) and Control.


  • Change in Quality of Life [ Time Frame: Baseline - 18 Month Follow Up Visit ]

    Change in the Minnesota Living with Heart Failure (MNLWHF) questionnaire from baseline to the 18-month follow-up visit.

    Change is defined as month 18 minus baseline.

    Per protocol change in MNLWHF is compared between Pooled Pacing (Dual Site + Single Site) and Control.


  • Incidence of Sudden Cardiac Death and Total Mortality [ Time Frame: 18 Months post-randomization ]

    Mortality rates (%) for the events (a) all-cause death and (b) sudden-cardiac death at 18 months post randomization. Calculated using Kaplan-Meier methods.

    Per protocol the comparison of mortality rates is between Pooled Pacing (Dual Site + Single Site) and Control.


  • Linear Association Between Change in LVEDV and Selected 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 ]

    Linear association between change in LVEDV from baseline to 18-month visit (i.e. ΔLVEDV) and the following clinical characteristics were assessed: age, days from MI to implant, gender, hypertension, hyperlipidemia, diabetes, peak CPK, infarct location, LV electrode in acceptable place, and baseline LVEF. In order to assess these linear associations, linear regression models were fitted for each of these clinical characteristics (separately). In particular, each linear regression model had baseline LVEDV and the clinical characteristic as covariates, and ΔLVEDV was the response variable.

    Variables resulting in statistical significant (p<0.05) are reported.



Enrollment: 129
Study Start Date: December 2010
Study Completion Date: April 2016
Primary Completion Date: October 2015 (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   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov Identifier: NCT01213251     History of Changes
Other Study ID Numbers: PRomPT
Study First Received: September 28, 2010
Results First Received: August 8, 2016
Last Updated: October 21, 2016

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 March 30, 2017