Skip to main content
OpenTrials
Completed

NCT Number: NCT01213251

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acute Myocardial Infarction Cardiac Remodeling Cardiovascular Diseases Heart Diseases Heart Failure Pacing Therapy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Rigshospitalet, Copenhagen, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Single Site Pacing

Device

Subjects will be implanted with a CRT-D that delivers pacing via the Left Ventricular lead.

Dual Site Pacing

Device

Subjects will be implanted with a CRT-D that delivers pacing via the Left Ventricular and Right Ventricular lead.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Frequency of Hospitalization for Cardiovascular Events

    Time frame: Baseline - 18 Month Follow Up Visit

    Number of hospitalizations related to cardiovascular events.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure

Industry

Registry information

Acronym: PRomPT

Important dates

Study start
2010
Primary completion
2015
Study completion
2016
First posted
Oct 1, 2010
Registry last updated
Dec 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.