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The Prevention of Myocardial Enlargement and Dilatation Post Myocardial Infarction Study

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ClinicalTrials.gov Identifier: NCT00605631
Recruitment Status : Completed
First Posted : January 31, 2008
Last Update Posted : April 5, 2017
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

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

Condition or disease Intervention/treatment Phase
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 Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Prevention of Myocardial Enlargement and Dilatation Post Myocardial Infarction Study
Actual Study Start Date : May 2005
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. LVEDV [ Time Frame: 12 months ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications of Results:
Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00605631     History of Changes
Other Study ID Numbers: MENDMI
First Posted: January 31, 2008    Key Record Dates
Last Update Posted: April 5, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Boston Scientific Corporation:
Pacing

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