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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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Given the existing controversy regarding the appropriate determination time for placement of implantable cardioverter-defibrillator (ICD) in patients at risk for sudden cardiac death (SCD) following acute myocardial infarction (AMI), the modest ability of current criteria to determine which patients will experience SCD, and the high impact of SCD to society, we propose to conduct a prospective non-randomized observational study to determine:
Primary hypothesis:
Percentage of left ventricular scar volume as measured by CMRI post-MI strongly correlates with LVEF at 40 days and 3 months.
Secondary hypothesis:
Safety hypothesis:
ICDs will be implanted if patients meet criteria at 40 days post MI as per the current American College of Cardiology (ACC) /American Heart Association (AHA) /Heart Rhythm Society (HRS) 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acute Myocardial Infarction | Patients (aged 18 and above) with either ST segment elevation or Non-ST segment elevation MI by biomarkers of cardiac injury and symptoms. Cut-off for CPK >2 times and troponin >3 times the upper limit for the lab. Only Patients who undergo coronary revascularization (PCI, CABG), New York Heart Association (NYHA) functional class I-III, and with LVEF < 45% will be enrolled. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in LVEF in post MI patients | The degree of LVEF recovery after a first MI provides important prognostic information. Patients with no recovery in LVEF after MI are at high risk of sudden cardiac arrest events and death. | 40 days post-MI and 3 months post-MI |
| Measure | Description | Time Frame |
|---|---|---|
| LVEF less than 35% | The degree of LVEF recovery after a first MI provides important prognostic information. Patients with no recovery in LVEF after MI are at high risk of sudden cardiac arrest events and death. | At 40 days post-MI |
| Cardiovascular Mortality |
| Measure | Description | Time Frame |
|---|---|---|
| Repeated Emergency Department visits | Safety outcomes include repeat Emergency Department (ED) visits, hospital admissions and major adverse cardiovascular events (all-cause mortality, cardiac death, non-fatal myocardial infarction and stroke). Performance of subsequent cardiac imaging studies, cardiac catheterization and coronary interventions will also be monitored as a reflection of test efficiency. | At 40 days post-MI |
Inclusion Criteria:
Exclusion Criteria:
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The proposed clinical setting of this observational study is mainly the community served by Montefiore Medical Center, the University Hospital of Albert Einstein College of Medicine. We will recruit approximately 200 patients over a year. This study will involve our two divisions (Moses and Weiler) and each study center will enroll approximately 100 patients per year.
AMI survivors either on telemetry floor or coronary care units who meet inclusion/exclusion criteria will be enrolled.
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| Name | Affiliation | Role |
|---|---|---|
| Mario Garcia, M.D. | Montefiore Medical Center/Albert Einstein College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montefiore Medical Center, Albert Einstein College of Medicine | The Bronx | New York | 10467 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16935995 | Background | Zipes DP, Camm AJ, Borggrefe M, Buxton AE, Chaitman B, Fromer M, Gregoratos G, Klein G, Moss AJ, Myerburg RJ, Priori SG, Quinones MA, Roden DM, Silka MJ, Tracy C, Smith SC Jr, Jacobs AK, Adams CD, Antman EM, Anderson JL, Hunt SA, Halperin JL, Nishimura R, Ornato JP, Page RL, Riegel B, Blanc JJ, Budaj A, Dean V, Deckers JW, Despres C, Dickstein K, Lekakis J, McGregor K, Metra M, Morais J, Osterspey A, Tamargo JL, Zamorano JL; American College of Cardiology/American Heart Association Task Force; European Society of Cardiology Committee for Practice Guidelines; European Heart Rhythm Association; Heart Rhythm Society. ACC/AHA/ESC 2006 Guidelines for Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death: a report of the American College of Cardiology/American Heart Association Task Force and the European Society of Cardiology Committee for Practice Guidelines (writing committee to develop Guidelines for Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death): developed in collaboration with the European Heart Rhythm Association and the Heart Rhythm Society. Circulation. 2006 Sep 5;114(10):e385-484. doi: 10.1161/CIRCULATIONAHA.106.178233. Epub 2006 Aug 25. No abstract available. | |
| 18984889 |
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| ID | Term |
|---|---|
| D016757 | Death, Sudden, Cardiac |
| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D003645 | Death, Sudden |
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Cardiovascular mortality in patients was defined as death attributable to myocardial ischemia and infarction, heart failure, cardiac arrest because of other or unknown cause, or cerebrovascular accident. |
| At 40 days post-MI |
| Cardiovascular Mortality | Cardiovascular mortality in patients was defined as death attributable to myocardial ischemia and infarction, heart failure, cardiac arrest because of other or unknown cause, or cerebrovascular accident. | at 3 months post-MI |
| Sustained ventricular tachycardia (VT) | Sustained ventricular tachycardia (VT) is a ventricular rhythm faster than 100 bpm lasting at least 30 seconds or requiring termination earlier due to hemodynamic instability. VT is defined as a wide complex tachycardia (QRS 120 milliseconds or greater) that originates from one of the ventricles, and is not due to aberrant conduction (e.g., from bundle branch block), at a rate of 100 bpm or greater. | At 40 days post-MI |
| Sustained ventricular fibrillation (VF) | Sustained ventricular fibrillation is malignant arrhythmia | At 40 days post-MI |
| Sustained ventricular tachycardia (VT) | Sustained ventricular tachycardia (VT) is a ventricular rhythm faster than 100 bpm lasting at least 30 seconds or requiring termination earlier due to hemodynamic instability. VT is defined as a wide complex tachycardia (QRS 120 milliseconds or greater) that originates from one of the ventricles, and is not due to aberrant conduction (e.g., from bundle branch block), at a rate of 100 bpm or greater. | At 3 months post-MI |
| Sustained ventricular fibrillation (VF) | Sustained ventricular fibrillation is malignant arrhythmia | At 3 months post-MI |
| Hospital admissions | Safety outcomes include include repeat ED visits, hospital admissions and major adverse cardiovascular events (all-cause mortality, cardiac death, non-fatal myocardial infarction and stroke). Performance of subsequent cardiac imaging studies, cardiac catheterization and coronary interventions will also be monitored as a reflection of test efficiency. | At 40 days post-MI |
| All-cause mortality | Safety outcomes include include repeat ED visits, hospital admissions and major adverse cardiovascular events (all-cause mortality, cardiac death, non-fatal myocardial infarction and stroke). Performance of subsequent cardiac imaging studies, cardiac catheterization and coronary interventions will also be monitored as a reflection of test efficiency. | At 40 days post-MI |
| Cardiac death | Safety outcomes include include repeat ED visits, hospital admissions and major adverse cardiovascular events (all-cause mortality, cardiac death, non-fatal myocardial infarction and stroke). Performance of subsequent cardiac imaging studies, cardiac catheterization and coronary interventions will also be monitored as a reflection of test efficiency. | At 40 days post-MI |
| non-fatal myocardial infarction | Safety outcomes include include repeat ED visits, hospital admissions and major adverse cardiovascular events (all-cause mortality, cardiac death, non-fatal myocardial infarction and stroke). Performance of subsequent cardiac imaging studies, cardiac catheterization and coronary interventions will also be monitored as a reflection of test efficiency. | At 40 days post-MI |
| Incidents of Stroke | Safety outcomes include include repeat ED visits, hospital admissions and major adverse cardiovascular events (all-cause mortality, cardiac death, non-fatal myocardial infarction and stroke). Performance of subsequent cardiac imaging studies, cardiac catheterization and coronary interventions will also be monitored as a reflection of test efficiency. | At 40 days post-MI |
| Background |
| Adabag AS, Therneau TM, Gersh BJ, Weston SA, Roger VL. Sudden death after myocardial infarction. JAMA. 2008 Nov 5;300(17):2022-9. doi: 10.1001/jama.2008.553. |
| 11738292 | Background | Bailey JJ, Berson AS, Handelsman H, Hodges M. Utility of current risk stratification tests for predicting major arrhythmic events after myocardial infarction. J Am Coll Cardiol. 2001 Dec;38(7):1902-11. doi: 10.1016/s0735-1097(01)01667-9. |
| 18498951 | Background | Epstein AE, DiMarco JP, Ellenbogen KA, Estes NA 3rd, Freedman RA, Gettes LS, Gillinov AM, Gregoratos G, Hammill SC, Hayes DL, Hlatky MA, Newby LK, Page RL, Schoenfeld MH, Silka MJ, Stevenson LW, Sweeney MO, Smith SC Jr, Jacobs AK, Adams CD, Anderson JL, Buller CE, Creager MA, Ettinger SM, Faxon DP, Halperin JL, Hiratzka LF, Hunt SA, Krumholz HM, Kushner FG, Lytle BW, Nishimura RA, Ornato JP, Page RL, Riegel B, Tarkington LG, Yancy CW; American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the ACC/AHA/NASPE 2002 Guideline Update for Implantation of Cardiac Pacemakers and Antiarrhythmia Devices); American Association for Thoracic Surgery; Society of Thoracic Surgeons. ACC/AHA/HRS 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the ACC/AHA/NASPE 2002 Guideline Update for Implantation of Cardiac Pacemakers and Antiarrhythmia Devices) developed in collaboration with the American Association for Thoracic Surgery and Society of Thoracic Surgeons. J Am Coll Cardiol. 2008 May 27;51(21):e1-62. doi: 10.1016/j.jacc.2008.02.032. No abstract available. |
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| D003643 |
| Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |