The Prevention of Myocardial Enlargement and Dilatation Post Myocardial Infarction Study

Study Overview
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Brief Summary
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This study is designed to evaluate the effect of pacing on post-MI patients.

Official Title
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The Prevention of Myocardial Enlargement and Dilatation Post Myocardial Infarction Study

Conditions
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Post Myocardial Infarction

Intervention / Treatment
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* Device: Cardiac pacing using any Guidant/Boston Scientific Implantable ICD or CRT-D System and any Guidant/Boston Scientific Intracardiac Lead System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 or above, or of legal age to give informed consent specific to state and national law Willing and capable of providing informed consent, participating in all testing associated with this clinical investigation at an approved clinical investigational center and at the intervals defined by this protocol Patient has had a clinically documented anterior myocardial infarction which occurred within the last 14 days Measured peak CK > 2000 mU/mL within 72 hours of MI. QRS duration < 120 ms measured by 12-lead ECG at any time after most recent MI Exclusion Criteria: Patient has atrial tachyarrhythmia that is permanent (i.e., does not terminate spontaneously and cannot be terminated with medical intervention) or persistent (i.e., can be terminated with medical intervention, but does not terminate spontaneously) at time of enrollment Patient is in cardiogenic shock defined by systolic blood pressure < 90 mmHg and on pressor/inotrope medications at time of potential enrollment Patient has 2 or 3 degree heart block at time of potential enrollment Patient has undergone or is scheduled for a coronary artery bypass graft procedure, 30 days before or 30 days after date of potential enrollment Patient has a known life expectancy of less than 6 months due to non cardiac causes Patient has marked renal dysfunction defined as Creatinine > 2.5 mg/dL at time of enrollment Patient enrolled in any concurrent study that may confound the results of the study Patient is in class IV heart failure Patient is on the heart transplant list Patient already has an implanted pacemaker, ICD, or CRT device Patient is pregnant or plans to be pregnant during the course of the study Both

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Device: Cardiac pacing using any Guidant/Boston Scientific Implantable ICD or CRT-D System and any Guidant/Boston Scientific Intracardiac Lead System<br>* No specific device model is required - any FDA-approved, market-released Guidant/Boston Scientific implantable ICD or CRT-D system and any FDA-approved, market-released Guidant/Boston Scientific intracardiac lead system may be implanted as part of MENDMI.<br>|
| Active Comparator: 2<br> | Device: Cardiac pacing using any Guidant/Boston Scientific Implantable ICD or CRT-D System and any Guidant/Boston Scientific Intracardiac Lead System<br>* No specific device model is required - any FDA-approved, market-released Guidant/Boston Scientific implantable ICD or CRT-D system and any FDA-approved, market-released Guidant/Boston Scientific intracardiac lead system may be implanted as part of MENDMI.<br>|
| Other: 3<br> | Device: Cardiac pacing using any Guidant/Boston Scientific Implantable ICD or CRT-D System and any Guidant/Boston Scientific Intracardiac Lead System<br>* No specific device model is required - any FDA-approved, market-released Guidant/Boston Scientific implantable ICD or CRT-D system and any FDA-approved, market-released Guidant/Boston Scientific intracardiac lead system may be implanted as part of MENDMI.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LVEDV |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LVESV |  | 12 months | 
| ECG |  | 12 months | 
| Blood chemistry |  | 12 months | 
| Device parameters |  | 12 months | 
| Quality of Life |  | 12 months | 
| Cardiac echo |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pacing