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OpenTrials
Completed

NCT Number: NCT00605631

The Prevention of Myocardial Enlargement and Dilatation Post Myocardial Infarction Study

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

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Christ Hospital

Cincinnati, Ohio, 45219, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

Primary outcomes

  1. LVEDV

    Time frame: 12 months

Secondary outcomes

  1. LVESV

    Time frame: 12 months

  2. ECG

    Time frame: 12 months

  3. Blood chemistry

    Time frame: 12 months

  4. Device parameters

    Time frame: 12 months

  5. Quality of Life

    Time frame: 12 months

  6. Cardiac echo

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Jan 31, 2008
Registry last updated
Apr 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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