The Prevention of Myocardial Enlargement and Dilatation Post Myocardial Infarction Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2009-03-31

Brief Summary

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

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Detailed Description

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Conditions

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Post Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

Cardiac pacing using any Guidant/Boston Scientific Implantable ICD or CRT-D System and any Guidant/Boston Scientific Intracardiac Lead System

Intervention Type DEVICE

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.

2

Group Type ACTIVE_COMPARATOR

Cardiac pacing using any Guidant/Boston Scientific Implantable ICD or CRT-D System and any Guidant/Boston Scientific Intracardiac Lead System

Intervention Type DEVICE

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.

3

Group Type OTHER

Cardiac pacing using any Guidant/Boston Scientific Implantable ICD or CRT-D System and any Guidant/Boston Scientific Intracardiac Lead System

Intervention Type DEVICE

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.

Interventions

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Cardiac pacing using any Guidant/Boston Scientific Implantable ICD or CRT-D System and any Guidant/Boston Scientific Intracardiac Lead System

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.

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No