Overview

This trial is active, not recruiting.

Conditions acute myocardial infarction, pacing therapy, cardiac remodeling, heart failure
Treatments single site pacing, dual site pacing
Phase phase 2
Sponsor Medtronic Cardiac Rhythm Disease Management
Start date December 2010
End date April 2015
Trial size 250 participants
Trial identifier NCT01213251, PRomPT

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
single site pacing
Subjects will be implanted with a CRT-D that delivers pacing via the Left Ventricular lead.
(Experimental)
dual site pacing
Subjects will be implanted with a CRT-D that delivers pacing via the Left Ventricular and Right Ventricular lead.
(No Intervention)

Primary Outcomes

Measure
Change in left ventricular end diastolic volume (LVEDV)
time frame: Baseline - 18 Month Follow Up Visit

Secondary Outcomes

Measure
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, time from MI onset to implant, and change in LV volumes.
time frame: Baseline - 18 Month Follow Up Visit

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Post-Myocardial Infarction Remodeling Prevention Therapy
Principal investigator Gregg Stone, MD
Trial information was received from ClinicalTrials.gov and was last updated in April 2014.
Information provided to ClinicalTrials.gov by Medtronic Cardiac Rhythm Disease Management.