Post-Myocardial Infarction Remodeling Prevention Therapy

• Register: ClinicalTrials.gov
• Last refreshed on: 13 May 2013
• Main ID: NCT01213251
• Date of registration: 28/09/2010
• Primary sponsor: Medtronic Cardiac Rhythm Disease Management
• Public title: Post-Myocardial Infarction Remodeling Prevention Therapy PRomPT
• Scientific title: Post-Myocardial Infarction Remodeling Prevention Therapy
• Date of first enrolment: December 2010
• Target sample size: 250
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01213251
• 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

Countries of recruitment

Denmark, France, Germany, Hungary, Saudi Arabia, Slovakia, United States

Contacts

• Name: Jennifer Heim

• Name: Gregg Stone, MD
• Affiliation: Columbia University

• Name: Angel Leon, MD
• Affiliation: Emory University

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Acute Myocardial Infarction

Cardiac Remodeling

Heart Failure

Pacing Therapy

Intervention(s)

Device: Dual Site Pacing

Device: Single Site Pacing

Primary Outcome(s)

Change in left ventricular end diastolic volume (LVEDV) [Time Frame: Baseline - 18 Month Follow Up Visit]

Secondary Outcome(s)

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]

Change in 6-minute walk test distance [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 quality of life [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]

Incidence of sudden cardiac death and total mortality [Time Frame: Baseline - 18 Month Follow Up Visit]

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]

Secondary ID(s)

PRomPT

Source(s) of Monetary Support

Please refer to primary and secondary sponsors