Post-Myocardial Infarction Remodeling Prevention Therapy (PRomPT)

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Acute Myocardial Infarction; Cardiac Remodeling; Pacing Therapy
• Intervention / Treatment: Device: Single Site Pacing; Device: Dual Site Pacing

• Study Type: Interventional
• Enrollment (Actual): 129
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Left Ventricular End Diastolic Volume (LVEDV)	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.	Baseline - 18 Month Follow Up Visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	18 months post-implant
Frequency of Hospitalization for Cardiovascular Events	Number of hospitalizations related to cardiovascular events.	Baseline - 18 Month Follow Up Visit
Change in New York Heart Association (NYHA) Functional Class	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.	Baseline - 18 Month Follow Up Visit
Change in 6-minute Walk Test Distance	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.	1 Month - 18 Month Follow Up Visit
Change in Quality of Life	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.	Baseline - 18 Month Follow Up Visit
Incidence of Sudden Cardiac Death and Total Mortality	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.	18 Months post-randomization
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.	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.	Baseline - 18 Month Follow Up Visit

Collaborators and Investigators

• Sponsor: Medtronic Cardiac Rhythm and Heart Failure
• Investigators: Principal Investigator: Angel Leon, MD, Emory University

Publications and helpful links

General Publications

• 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.

Helpful Links

• The Post-Myocardial Infarction Pacing Remodeling Prevention Therapy (PRomPT) Trial: Design and Rationale

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: September 28, 2010
• First Submitted That Met QC Criteria: September 30, 2010
• First Posted (Estimate): October 1, 2010

Study Record Updates

• Last Update Posted (Estimate): December 15, 2016
• Last Update Submitted That Met QC Criteria: October 21, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction
• Other Study ID Numbers: PROMPT