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The Prevention of Myocardial Enlargement and Dilatation Post Myocardial Infarction Study

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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

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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