The Prevention of Myocardial Enlargement and Dilatation Post Myocardial Infarction Study
Status: | Completed |
---|---|
Conditions: | Cardiology, Orthopedic |
Therapuetic Areas: | Cardiology / Vascular Diseases, Orthopedics / Podiatry |
Healthy: | No |
Age Range: | 18 - 100 |
Updated: | 4/6/2017 |
Start Date: | May 2005 |
End Date: | March 2009 |
This study is designed to evaluate the effect of pacing on post-MI patients.
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
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