Post-Myocardial Infarction Remodeling Prevention Therapy

Phase 2

Completed

Conditions: Pacing Therapy
Cardiac Remodeling
Acute Myocardial Infarction
Heart Failure

Interventions: Device: Single Site Pacing
Device: Dual Site Pacing

Registration Number: NCT01213251

Lead Sponsor: Medtronic Cardiac Rhythm and Heart Failure

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 129

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single Site Pacing	Single Site Pacing	-
Dual Site Pacing	Dual Site Pacing	-

Primary Outcome Measures

Name	Time	Method
Change in Left Ventricular End Diastolic Volume (LVEDV)	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

Name	Time	Method
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	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	Baseline - 18 Month Follow Up Visit	Number of hospitalizations related to cardiovascular events.
Change in New York Heart Association (NYHA) Functional Class	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	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	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	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.	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.

Trial Locations

Locations (26): Kaiser Permanente
🇺🇸
Los Angeles, California, United States
Emory University Hospital Midtown
🇺🇸
Atlanta, Georgia, United States
Cleveland Clinic Foundation
🇺🇸
Cleveland, Ohio, United States
University of Pittsburgh Medical Center
🇺🇸
Pittsburgh, Pennsylvania, United States
Saint Thomas Research Institute, LLC
🇺🇸
Nashville, Tennessee, United States
Baylor Jack and Jane Hamilton Heart and Vascular Hospital
🇺🇸
Dallas, Texas, United States
Maygar Honvédség Honvédkorház
🇭🇺
Budapest, Hungary
Vychodoslovensky ustav srdcovych a cievnych chorob, a.s.
🇸🇰
Kosice, Slovakia
Arizona Arrhythmia Consultants
🇺🇸
Scottsdale, Arizona, United States
Massachusetts General Hospital
🇺🇸
Boston, Massachusetts, United States
Lexington Cardiac Research Foundation
🇺🇸
Lexington, Kentucky, 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
Rigshospitalet
🇩🇰
Copenhagen, Denmark
The Stern Cardiovascular Foundation
🇺🇸
Germantown, Tennessee, United States
Delgado Cardiovascular Associates
🇺🇸
Houston, Texas, United States
Spokane Cardiology
🇺🇸
Spokane, Washington, United States
Hôpital Cardiologique du Haut-Lévêque
🇫🇷
Bordeaux-Pessac, France
Prince Salman Heart Centre
🇸🇦
King Fahad Medical City, Saudi Arabia
Semmelweis University Heart Center
🇭🇺
Budapest, Hungary
University Hospital Mannheim
🇩🇪
Mannheim, Germany
Herzzentrum Leipzig GmbH
🇩🇪
Leipzig, Germany
Centre Hospitalier Régional Universitaire de Lille
🇫🇷
Lille, France
Hospital of the University of Pennsylvania
🇺🇸
Philadelphia, Pennsylvania, United States
The Chattanooga Heart Institute
🇺🇸
Chattanooga, Tennessee, United States