The Prevention of Myocardial Enlargement and Dilatation Post Myocardial Infarction Study
Not Applicable
Completed
- Conditions
- Post Myocardial Infarction
- Registration Number
- NCT00605631
- Lead Sponsor
- Boston Scientific Corporation
- Brief Summary
This study is designed to evaluate the effect of pacing on post-MI patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 105
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method LVEDV 12 months
- Secondary Outcome Measures
Name Time Method Device parameters 12 months Quality of Life 12 months Cardiac echo 12 months Blood chemistry 12 months ECG 12 months LVESV 12 months
Trial Locations
- Locations (1)
Christ Hospital
🇺🇸Cincinnati, Ohio, United States
Christ Hospital🇺🇸Cincinnati, Ohio, United States