The Prevention of Myocardial Enlargement and Dilatation Post Myocardial Infarction Study
April 4, 2017 updated by: Boston Scientific Corporation
This study is designed to evaluate the effect of pacing on post-MI patients.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
105
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Cincinnati, Ohio, United States, 45219
- Christ Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1
|
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
|
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.
|
|
Other: 3
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
LVEDV
Time Frame: 12 months
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Quality of Life
Time Frame: 12 months
|
12 months
|
|
LVESV
Time Frame: 12 months
|
12 months
|
|
ECG
Time Frame: 12 months
|
12 months
|
|
Blood chemistry
Time Frame: 12 months
|
12 months
|
|
Device parameters
Time Frame: 12 months
|
12 months
|
|
Cardiac echo
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Eugene Chung, MD, Christ Hospital Cincinnati
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2005
Primary Completion (Actual)
March 1, 2009
Study Completion (Actual)
March 1, 2009
Study Registration Dates
First Submitted
December 20, 2007
First Submitted That Met QC Criteria
January 29, 2008
First Posted (Estimate)
January 31, 2008
Study Record Updates
Last Update Posted (Actual)
April 5, 2017
Last Update Submitted That Met QC Criteria
April 4, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MENDMI
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.