Post-Myocardial Infarction Remodeling Prevention Therapy (PRomPT)
|Acute Myocardial Infarction Pacing Therapy Cardiac Remodeling Heart Failure||Device: Single Site Pacing Device: Dual Site Pacing||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Post-Myocardial Infarction Remodeling Prevention Therapy|
- 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.
- 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.
|Study Start Date:||December 2010|
|Study Completion Date:||April 2016|
|Primary Completion Date:||October 2015 (Final data collection date for primary outcome measure)|
|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|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01213251
Hide Study Locations
|United States, Arizona|
|Arizona Arrhythmia Consultants|
|Scottsdale, Arizona, United States, 85251|
|United States, California|
|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, Washington, United States, 99204|
|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|
|King Fahad Medical City, Saudi Arabia|
|Vychodoslovensky ustav srdcovych a cievnych chorob, a.s.|
|Principal Investigator:||Gregg Stone, MD||Columbia University|
|Principal Investigator:||Angel Leon, MD||Emory University|