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
Click here to add this to my saved trials
Click here to add this to my saved trials
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...
Click here to add this to my saved trials
Emory University Hospital Midtown Emory University Hospital Midtown is a 511-bed community-based, acute care teaching...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials