The Prevention of Myocardial Enlargement and Dilatation Post Myocardial Infarction Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00605631
First received: December 20, 2007
Last updated: February 1, 2012
Last verified: February 2012
  Purpose

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


Condition Intervention
Post Myocardial Infarction
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
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Prevention of Myocardial Enlargement and Dilatation Post Myocardial Infarction Study

Resource links provided by NLM:


Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • LVEDV [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • LVESV [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • ECG [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Blood chemistry [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Device parameters [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Cardiac echo [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 105
Study Start Date: May 2005
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Device: 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.
Active Comparator: 2 Device: 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.
3 Device: 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00605631

Locations
United States, Ohio
Christ Hospital
Cincinnati, Ohio, United States, 45219
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Principal Investigator: Eugene Chung, MD Christ Hospital Cincinnati
  More Information

Publications:
Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00605631     History of Changes
Other Study ID Numbers: MENDMI
Study First Received: December 20, 2007
Last Updated: February 1, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Boston Scientific Corporation:
Pacing

Additional relevant MeSH terms:
Dilatation, Pathologic
Hypertrophy
Infarction
Myocardial Infarction
Pathological Conditions, Anatomical
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on July 20, 2014