Post-Myocardial Infarction Remodeling Prevention Therapy (PRomPT)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT01213251
First received: September 28, 2010
Last updated: November 1, 2013
Last verified: November 2013

September 28, 2010
November 1, 2013
December 2010
April 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 ] [ Designated as safety issue: No ]
Same as current
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: Baseline - 18 Month Follow Up Visit ] [ Designated as safety issue: No ]
  • Frequency of hospitalization for heart failure and cardiovascular events [ Time Frame: Baseline - 18 Month Follow Up Visit ] [ Designated as safety issue: No ]
  • Change in New York Heart Association (NYHA) functional class [ Time Frame: Baseline - 18 Month Follow Up Visit ] [ Designated as safety issue: No ]
  • Change in 6-minute walk test distance [ Time Frame: Baseline - 18 Month Follow Up Visit ] [ Designated as safety issue: No ]
  • Change in quality of life [ Time Frame: Baseline - 18 Month Follow Up Visit ] [ Designated as safety issue: No ]
  • Incidence of sudden cardiac death and total mortality [ Time Frame: Baseline - 18 Month Follow Up Visit ] [ Designated as safety issue: No ]
  • Association between 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Frequency of hospitalization for heart failure and cardiovascular events [ Time Frame: Baseline - 18 Month Follow Up Visit ] [ Designated as safety issue: No ]
  • Change in New York Heart Association (NYHA) functional class [ Time Frame: Baseline - 18 Month Follow Up Visit ] [ Designated as safety issue: No ]
  • Change in 6-minute walk test distance [ Time Frame: Baseline - 18 Month Follow Up Visit ] [ Designated as safety issue: No ]
  • Change in quality of life [ Time Frame: Baseline - 18 Month Follow Up Visit ] [ Designated as safety issue: No ]
  • Incidence of sudden cardiac death and total mortality [ Time Frame: Baseline - 18 Month Follow Up Visit ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
250
Not Provided
April 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • MI within the past 10 days
  • Peak 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
  • 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Denmark,   France,   Germany,   Hungary,   Saudi Arabia,   Slovakia
 
NCT01213251
PRomPT
Yes
Medtronic Cardiac Rhythm Disease Management
Medtronic Cardiac Rhythm Disease Management
Not Provided
Principal Investigator: Gregg Stone, MD Columbia University
Principal Investigator: Angel Leon, MD Emory University
Medtronic Cardiac Rhythm Disease Management
November 2013

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