Phase 2
N=126
Post-Myocardial Infarction Remodeling Prevention Therapy
Acute Myocardial Infarction · Pacing Therapy · Cardiac Remodeling · Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT01213251 ↗Enrolled (actual)
126
Serious AEs
52.4%
Results posted
Dec 2016
Primary outcome: Primary: Change in Left Ventricular End Diastolic Volume (LVEDV) — 16.4; 15.8 mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Single Site Pacing (Device); Dual Site Pacing (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Primary completion
- Oct 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Left Ventricular End Diastolic Volume (LVEDV) |
16.4; 15.8 | — |
| SECONDARY 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 |
0.59; 0.68; 0.86; 0.87; 0.57; 0.66 | — |
| SECONDARY Frequency of Hospitalization for Cardiovascular Events |
27; 22; 30; 6; 9; 11 | — |
| SECONDARY Change in New York Heart Association (NYHA) Functional Class |
26; 13; 25; 10; 17; 10 | — |
| SECONDARY Change in 6-minute Walk Test Distance |
37.6; 15.6 | — |
| SECONDARY Change in Quality of Life |
0.4; -0.1 | — |
| SECONDARY Incidence of Sudden Cardiac Death and Total Mortality |
4.0; 4.7; 1.4; 2.4 | — |
| SECONDARY 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. |
-0.75; -3.78; -0.87 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01213251). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.