The Prevention of Myocardial Enlargement and Dilatation Post Myocardial Infarction Study
Primary Purpose
Post Myocardial Infarction
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cardiac pacing using any Guidant/Boston Scientific Implantable ICD or CRT-D System and any Guidant/Boston Scientific Intracardiac Lead System
Sponsored by
About this trial
This is an interventional treatment trial for Post Myocardial Infarction focused on measuring Pacing
Eligibility 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
Sites / Locations
- Christ Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Other
Arm Label
1
2
3
Arm Description
Outcomes
Primary Outcome Measures
LVEDV
Secondary Outcome Measures
LVESV
ECG
Blood chemistry
Device parameters
Quality of Life
Cardiac echo
Full Information
NCT ID
NCT00605631
First Posted
December 20, 2007
Last Updated
April 4, 2017
Sponsor
Boston Scientific Corporation
1. Study Identification
Unique Protocol Identification Number
NCT00605631
Brief Title
The Prevention of Myocardial Enlargement and Dilatation Post Myocardial Infarction Study
Official Title
The Prevention of Myocardial Enlargement and Dilatation Post Myocardial Infarction Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
May 2005 (Actual)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is designed to evaluate the effect of pacing on post-MI patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Myocardial Infarction
Keywords
Pacing
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
105 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Arm Title
3
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Cardiac pacing using any Guidant/Boston Scientific Implantable ICD or CRT-D System and any Guidant/Boston Scientific Intracardiac Lead System
Intervention Description
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 Measure Information:
Title
LVEDV
Time Frame
12 months
Secondary Outcome Measure Information:
Title
LVESV
Time Frame
12 months
Title
ECG
Time Frame
12 months
Title
Blood chemistry
Time Frame
12 months
Title
Device parameters
Time Frame
12 months
Title
Quality of Life
Time Frame
12 months
Title
Cardiac echo
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eugene Chung, MD
Organizational Affiliation
Christ Hospital Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
Christ Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
20852059
Citation
Chung ES, Dan D, Solomon SD, Bank AJ, Pastore J, Iyer A, Berger RD, Franklin JO, Jones G, Machado C, Stolen CM. Effect of peri-infarct pacing early after myocardial infarction: results of the prevention of myocardial enlargement and dilatation post myocardial infarction study. Circ Heart Fail. 2010 Nov;3(6):650-8. doi: 10.1161/CIRCHEARTFAILURE.110.945881. Epub 2010 Sep 17.
Results Reference
result
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The Prevention of Myocardial Enlargement and Dilatation Post Myocardial Infarction Study
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