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: April 23, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Acute Myocardial Infarction
Pacing Therapy
Cardiac Remodeling
Heart Failure
Device: Single Site Pacing
Device: Dual Site Pacing
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Post-Myocardial Infarction Remodeling Prevention Therapy

Resource links provided by NLM:


Further study details as provided by Medtronic Cardiac Rhythm Disease Management:

Primary Outcome Measures:
  • Change in left ventricular end diastolic volume (LVEDV) [ Time Frame: Baseline - 18 Month Follow Up Visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 250
Study Start Date: December 2010
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01213251

  Show 24 Study Locations
Sponsors and Collaborators
Medtronic Cardiac Rhythm Disease Management
Investigators
Principal Investigator: Gregg Stone, MD Columbia University
Principal Investigator: Angel Leon, MD Emory University
  More Information

No publications provided

Responsible Party: Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier: NCT01213251     History of Changes
Other Study ID Numbers: PRomPT
Study First Received: September 28, 2010
Last Updated: April 23, 2014
Health Authority: United States: Food and Drug Administration
Denmark: Danish Medicines Agency
Slovakia: State Institute for Drug Control
Saudi Arabia: No oversight authority approval required
France:French Agency for the Safety of Health Products
Hungary:Office of Health Authorization and Administrative Procedures
Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Heart Failure
Infarction
Myocardial Infarction
Heart Diseases
Cardiovascular Diseases
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Vascular Diseases

ClinicalTrials.gov processed this record on July 20, 2014