The Prevention of Myocardial Enlargement and Dilatation Post Myocardial Infarction Study

Boston Scientific

Status: Completed

Conditions: Post Myocardial Infarction

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00605631

MENDMI

Details and patient eligibility

About

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

Enrollment: 105 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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105 participants in 3 patient groups

1

Experimental group

Treatment:

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

2

Active Comparator group

Treatment:

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

3

Other group

Treatment:

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