The Prevention of Myocardial Enlargement and Dilatation Post Myocardial Infarction Study
This study has been completed.
Sponsor:
Boston Scientific Corporation
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
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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
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 June 18, 2013