Post-Myocardial Infarction Remodeling Prevention Therapy
Status: | Recruiting |
---|---|
Conditions: | Cardiology |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 11/23/2013 |
Start Date: | December 2010 |
Contact: | Marina Ostanniy |
Email: | rs.prompt@medtronic.com |
Phone: | (763) 526-9751 |
The purpose of this study is to demonstrate the feasibility of pacing as a therapy to
prevent adverse remodeling of the myocardium following an acute myocardial infarction (MI)
in patients at highest risk for adverse myocardial remodeling.
Inclusion Criteria:
- MI within the past 10 days
- Peak CPK greater than 3000 Units/Litre (U/L) at time of MI, or a troponin T (TnT)
greater than 10 micrograms/Litre (mcg/L)
- At least 18 years old
- Willing to comply with the protocol
Exclusion Criteria:
- Documented MI greater than 10 days
- Chronic renal disease, as defined by estimated glomerular filtration rate (eGFR) less
than 30 milliliters/minute/1.73 square meter
- Life expectancy less than 18 months, as determined by a physician
- Existing pacemaker, Implantable Cardioverter Defibrillator (ICD), or Cardiac
Resynchronization Therapy (CRT) device
- QRS duration greater than 120 milliseconds (ms)
- Coronary Artery Bypass Graft (CABG) within 30 days prior to MI, or CABG procedure
planned
- Third degree atrioventricular (AV) block or symptomatic bradyarrhythmia
- Persistent atrial fibrillation (AF) that is not self terminating within 7 days or is
terminated electrically or pharmacologically
- Permanent AF that is non self terminating, with cardioversion failed or not attempted
within the past year
- NYHA Class IV
- Non-ischemic cardiomyopathy
- Pregnant or planning to become pregnant during the study
- Enrolled or planning to participate in a concurrent drug and/or device study during
the course of this clinical trial. Co-enrollment in concurrent trials is only allowed
with documented pre-approval from Medtronic, documenting that there is not a concern
that co-enrollment could confound the results of this trial.
- Breast feeding
- Of a vulnerable population as determined by local law or requirement, or a physician
We found this trial at
17
sites
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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3400 Spruce St
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
(215) 662-4000
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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Emory University Hospital Midtown Emory University Hospital Midtown is a 511-bed community-based, acute care teaching...
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Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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