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Post-Myocardial Infarction Remodeling Prevention Therapy (PRomPT)

Primary Purpose

Acute Myocardial Infarction, Pacing Therapy, Cardiac Remodeling

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Single Site Pacing
Dual Site Pacing
Sponsored by
Medtronic Cardiac Rhythm and Heart Failure
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Myocardial Infarction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Arizona Arrhythmia Consultants
  • Kaiser Permanente
  • Emory University Hospital Midtown
  • Lexington Cardiac Research Foundation
  • Massachusetts General Hospital
  • Michigan Heart, PC
  • Carolina Heart Specialists
  • Lindner Clinical Trial Center
  • Cleveland Clinic Foundation
  • Hospital of the University of Pennsylvania
  • University of Pittsburgh Medical Center
  • The Chattanooga Heart Institute
  • The Stern Cardiovascular Foundation
  • Saint Thomas Research Institute, LLC
  • Baylor Jack and Jane Hamilton Heart and Vascular Hospital
  • Delgado Cardiovascular Associates
  • Spokane Cardiology
  • Rigshospitalet
  • Hôpital Cardiologique du Haut-Lévêque
  • Centre Hospitalier Régional Universitaire de Lille
  • Herzzentrum Leipzig GmbH
  • University Hospital Mannheim
  • Maygar Honvédség Honvédkorház
  • Semmelweis University Heart Center
  • Prince Salman Heart Centre
  • Vychodoslovensky ustav srdcovych a cievnych chorob, a.s.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Single Site Pacing

Dual Site Pacing

Control

Arm Description

Outcomes

Primary Outcome Measures

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.

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
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
Number of hospitalizations related to cardiovascular events.
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.
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.
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.
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.
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.

Full Information

First Posted
September 28, 2010
Last Updated
October 21, 2016
Sponsor
Medtronic Cardiac Rhythm and Heart Failure
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1. Study Identification

Unique Protocol Identification Number
NCT01213251
Brief Title
Post-Myocardial Infarction Remodeling Prevention Therapy
Acronym
PRomPT
Official Title
Post-Myocardial Infarction Remodeling Prevention Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Cardiac Rhythm and Heart Failure

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction, Pacing Therapy, Cardiac Remodeling, Heart Failure

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
129 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single Site Pacing
Arm Type
Experimental
Arm Title
Dual Site Pacing
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Single Site Pacing
Intervention Description
Subjects will be implanted with a CRT-D that delivers pacing via the Left Ventricular lead.
Intervention Type
Device
Intervention Name(s)
Dual Site Pacing
Intervention Description
Subjects will be implanted with a CRT-D that delivers pacing via the Left Ventricular and Right Ventricular lead.
Primary Outcome Measure Information:
Title
Change in Left Ventricular End Diastolic Volume (LVEDV)
Description
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.
Time Frame
Baseline - 18 Month Follow Up Visit
Secondary Outcome Measure Information:
Title
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
Description
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.
Time Frame
18 months post-implant
Title
Frequency of Hospitalization for Cardiovascular Events
Description
Number of hospitalizations related to cardiovascular events.
Time Frame
Baseline - 18 Month Follow Up Visit
Title
Change in New York Heart Association (NYHA) Functional Class
Description
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.
Time Frame
Baseline - 18 Month Follow Up Visit
Title
Change in 6-minute Walk Test Distance
Description
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.
Time Frame
1 Month - 18 Month Follow Up Visit
Title
Change in Quality of Life
Description
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.
Time Frame
Baseline - 18 Month Follow Up Visit
Title
Incidence of Sudden Cardiac Death and Total Mortality
Description
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.
Time Frame
18 Months post-randomization
Title
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.
Description
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.
Time Frame
Baseline - 18 Month Follow Up Visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregg Stone, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Angel Leon, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arizona Arrhythmia Consultants
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
Facility Name
Kaiser Permanente
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Emory University Hospital Midtown
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Lexington Cardiac Research Foundation
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Michigan Heart, PC
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48197
Country
United States
Facility Name
Carolina Heart Specialists
City
Gastonia
State/Province
North Carolina
ZIP/Postal Code
28054
Country
United States
Facility Name
Lindner Clinical Trial Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
The Chattanooga Heart Institute
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
The Stern Cardiovascular Foundation
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Saint Thomas Research Institute, LLC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
Baylor Jack and Jane Hamilton Heart and Vascular Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75226
Country
United States
Facility Name
Delgado Cardiovascular Associates
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Spokane Cardiology
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Rigshospitalet
City
Copenhagen
Country
Denmark
Facility Name
Hôpital Cardiologique du Haut-Lévêque
City
Bordeaux-Pessac
Country
France
Facility Name
Centre Hospitalier Régional Universitaire de Lille
City
Lille
Country
France
Facility Name
Herzzentrum Leipzig GmbH
City
Leipzig
Country
Germany
Facility Name
University Hospital Mannheim
City
Mannheim
Country
Germany
Facility Name
Maygar Honvédség Honvédkorház
City
Budapest
Country
Hungary
Facility Name
Semmelweis University Heart Center
City
Budapest
Country
Hungary
Facility Name
Prince Salman Heart Centre
City
King Fahad Medical City
Country
Saudi Arabia
Facility Name
Vychodoslovensky ustav srdcovych a cievnych chorob, a.s.
City
Kosice
Country
Slovakia

12. IPD Sharing Statement

Citations:
PubMed Identifier
26321236
Citation
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.
Results Reference
derived
Links:
URL
http://dx.doi.org/10.1016/j.cardfail.2015.03.005
Description
The Post-Myocardial Infarction Pacing Remodeling Prevention Therapy (PRomPT) Trial: Design and Rationale

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Post-Myocardial Infarction Remodeling Prevention Therapy

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