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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
September 28, 2010
October 21, 2016
December 2010
October 2015   (Final data collection date for primary outcome measure)
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.

Change in Left Ventricular End Diastolic Volume (LVEDV) [ Time Frame: Baseline - 18 Month Follow Up Visit ]
Complete list of historical versions of study NCT01213251 on ClinicalTrials.gov Archive Site
  • 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.

  • 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: Baseline - 18 Month Follow Up Visit ]
  • Frequency of hospitalization for heart failure and cardiovascular events [ Time Frame: Baseline - 18 Month Follow Up Visit ]
  • Change in New York Heart Association (NYHA) Functional Class [ Time Frame: Baseline - 18 Month Follow Up Visit ]
  • Change in 6-minute Walk Test Distance [ Time Frame: Baseline - 18 Month Follow Up Visit ]
  • Change in Quality of Life [ Time Frame: Baseline - 18 Month Follow Up Visit ]
  • Incidence of Sudden Cardiac Death and Total Mortality [ Time Frame: Baseline - 18 Month Follow Up Visit ]
  • Association between clinical characteristics, including peak creatinine phosphokinase (CPK), peak troponin, lead location, and time from MI onset to implant, and change in LV volumes [ Time Frame: Baseline - 18 Month Follow Up Visit ]
Not Provided
Not Provided
 
Post-Myocardial Infarction Remodeling Prevention Therapy
Post-Myocardial Infarction Remodeling Prevention Therapy
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
  • Acute Myocardial Infarction
  • Pacing Therapy
  • Cardiac Remodeling
  • Heart Failure
  • Device: Single Site Pacing
    Subjects will be implanted with a CRT-D that delivers pacing via the Left Ventricular lead.
  • Device: Dual Site Pacing
    Subjects will be implanted with a CRT-D that delivers pacing via the Left Ventricular and Right Ventricular lead.
  • Experimental: Single Site Pacing
    Intervention: Device: Single Site Pacing
  • Experimental: Dual Site Pacing
    Intervention: Device: Dual Site Pacing
  • No Intervention: Control
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
129
April 2016
October 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Denmark,   France,   Germany,   Hungary,   Saudi Arabia,   Slovakia,   United States
 
 
NCT01213251
PRomPT
Yes
Not Provided
Not Provided
Medtronic Cardiac Rhythm and Heart Failure
Medtronic Cardiac Rhythm and Heart Failure
Not Provided
Principal Investigator: Gregg Stone, MD Columbia University
Principal Investigator: Angel Leon, MD Emory University
Medtronic Cardiac Rhythm and Heart Failure
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP