Brief Summary
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:
* Whether quantification of left ventricular (LV) scar volume by cardiac magnetic resonance (CMRI) prior to hospital discharge helps to predict which patients will have a low ejection fraction (35%) at follow up and qualify for ICD implantation.
* Whether quantification of infarct scar volume by CMRI will help to identify which patients will experience malignant ventricular arrhythmias and/or SCD at follow-up, independent of the LV ejection fraction (LVEF).
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:
1. A volume of \>40% of left ventricular scar measured by CMRI post-MI is predictive of LVEF less than 35% at 40 days and at 3 months
2. Volume scar as measured by Cardiac magnetic resonance imaging after AMI (at day 5) is predictive of clinical outcomes: SCD, total mortality, heart failure admission and life-threatening malignant ventricular arrhythmias regardless of ejection fraction at 40 days and at 3 months.
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
* Whether quantification of left ventricular (LV) scar volume by cardiac magnetic resonance (CMRI) prior to hospital discharge helps to predict which patients will have a low ejection fraction (35%) at follow up and qualify for ICD implantation.
* Whether quantification of infarct scar volume by CMRI will help to identify which patients will experience malignant ventricular arrhythmias and/or SCD at follow-up, independent of the LV ejection fraction (LVEF).
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:
1. A volume of \>40% of left ventricular scar measured by CMRI post-MI is predictive of LVEF less than 35% at 40 days and at 3 months
2. Volume scar as measured by Cardiac magnetic resonance imaging after AMI (at day 5) is predictive of clinical outcomes: SCD, total mortality, heart failure admission and life-threatening malignant ventricular arrhythmias regardless of ejection fraction at 40 days and at 3 months.
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
Brief Title
Risk Stratification After Acute Myocardial Infarction With Cardiac MRI
Categories
Completion Date
Completion Date Type
Actual
Conditions
Acute Myocardial Infarction (AMI)
Eligibility Criteria
Inclusion Criteria:
* Evidence of AMI either ST segment elevation or Non-ST segment elevation MI by biomarkers of cardiac injury and symptoms. Cut-off for creatine phosphokinase (CPK) \>2 times and troponin \>3 times the upper limit for the lab. Only Patients who undergo coronary revascularization (PCI, CABG) will be enrolled.
* LVEF \< 45%. (Based on 10 points SD in echo measurements for LVEF)
* NYHA functional class I-III
* Patients aged 18 or above, both genders.
Exclusion Criteria:
* Patients with spontaneous or induced sustained ventricular tachycardia after 48-72 hours. (30 beats or more at 120 bpm or greater)
* Absolute contraindications to undergo CMRI (Renal failure with GFR\<30% or ICD/PPM)
* Antiarrhythmic medications for ventricular arrhythmias (other than beta-blockers)
* Severe non-ischemic cardiac pathology. (e.g., ARVD, HCM, severe, restrictive cardiomyopathies (amiloydosis/sarcoidosis). We are aware that non-ischemic and ischemic cardiomyopathy may co-exist. However, these cardiomyopathies convey further arrhythmic risk and diffuse LV impairment.
* Unwilling or unable to provide informed consent
* Life expectancy less than 1 year.
* Current drug or alcohol abuse.
* Pregnancy
* Claustrophobia
* Patients who are enrolled in other trials with a treatment arm. (Patients enrolled in diagnostic trials can be included).
* Difficulty to attend the follow-up schedule due to a history of medical noncompliance, living a distance from the study center, or anticipated nonresidence in the area for the length of time required for follow-up.
* Evidence of AMI either ST segment elevation or Non-ST segment elevation MI by biomarkers of cardiac injury and symptoms. Cut-off for creatine phosphokinase (CPK) \>2 times and troponin \>3 times the upper limit for the lab. Only Patients who undergo coronary revascularization (PCI, CABG) will be enrolled.
* LVEF \< 45%. (Based on 10 points SD in echo measurements for LVEF)
* NYHA functional class I-III
* Patients aged 18 or above, both genders.
Exclusion Criteria:
* Patients with spontaneous or induced sustained ventricular tachycardia after 48-72 hours. (30 beats or more at 120 bpm or greater)
* Absolute contraindications to undergo CMRI (Renal failure with GFR\<30% or ICD/PPM)
* Antiarrhythmic medications for ventricular arrhythmias (other than beta-blockers)
* Severe non-ischemic cardiac pathology. (e.g., ARVD, HCM, severe, restrictive cardiomyopathies (amiloydosis/sarcoidosis). We are aware that non-ischemic and ischemic cardiomyopathy may co-exist. However, these cardiomyopathies convey further arrhythmic risk and diffuse LV impairment.
* Unwilling or unable to provide informed consent
* Life expectancy less than 1 year.
* Current drug or alcohol abuse.
* Pregnancy
* Claustrophobia
* Patients who are enrolled in other trials with a treatment arm. (Patients enrolled in diagnostic trials can be included).
* Difficulty to attend the follow-up schedule due to a history of medical noncompliance, living a distance from the study center, or anticipated nonresidence in the area for the length of time required for follow-up.
Inclusion Criteria
Inclusion Criteria:
* Evidence of AMI either ST segment elevation or Non-ST segment elevation MI by biomarkers of cardiac injury and symptoms. Cut-off for creatine phosphokinase (CPK) \>2 times and troponin \>3 times the upper limit for the lab. Only Patients who undergo coronary revascularization (PCI, CABG) will be enrolled.
* LVEF \< 45%. (Based on 10 points SD in echo measurements for LVEF)
* NYHA functional class I-III
* Patients aged 18 or above, both genders.
* Evidence of AMI either ST segment elevation or Non-ST segment elevation MI by biomarkers of cardiac injury and symptoms. Cut-off for creatine phosphokinase (CPK) \>2 times and troponin \>3 times the upper limit for the lab. Only Patients who undergo coronary revascularization (PCI, CABG) will be enrolled.
* LVEF \< 45%. (Based on 10 points SD in echo measurements for LVEF)
* NYHA functional class I-III
* Patients aged 18 or above, both genders.
Gender
All
Gender Based
false
Keywords
Sudden Cardiac Death
Acute Myocardial Infarction
Implantable Cardioverter Defibrillator
Cardiac Magnetic Resonance
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT03725826
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
13-01-023
Overall Status
Completed
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Risk Stratification for Sudden Cardiac Death After Acute Myocardial Infarction by Measuring Left Ventricular Volume Scar With Cardiac MRI
Primary Outcomes
Outcome Description
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.
Outcome Measure
Change in LVEF in post MI patients
Outcome Time Frame
40 days post-MI and 3 months post-MI
Secondary Outcomes
Outcome Description
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.
Outcome Time Frame
At 40 days post-MI
Outcome Measure
LVEF less than 35%
Outcome Description
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.
Outcome Time Frame
At 40 days post-MI
Outcome Measure
Cardiovascular Mortality
Outcome Description
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.
Outcome Time Frame
at 3 months post-MI
Outcome Measure
Cardiovascular Mortality
Outcome Description
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.
Outcome Time Frame
At 40 days post-MI
Outcome Measure
Sustained ventricular tachycardia (VT)
Outcome Description
Sustained ventricular fibrillation is malignant arrhythmia
Outcome Time Frame
At 40 days post-MI
Outcome Measure
Sustained ventricular fibrillation (VF)
Outcome Description
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.
Outcome Time Frame
At 3 months post-MI
Outcome Measure
Sustained ventricular tachycardia (VT)
Outcome Description
Sustained ventricular fibrillation is malignant arrhythmia
Outcome Time Frame
At 3 months post-MI
Outcome Measure
Sustained ventricular fibrillation (VF)
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Study Population
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.
AMI survivors either on telemetry floor or coronary care units who meet inclusion/exclusion criteria will be enrolled.
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Mario Garcia
Investigator Email
mariogar@montefiore.org
Investigator Phone
718-920-4172