Risk Stratification After Acute Myocardial Infarction With Cardiac MRI

Acute Myocardial Infarction (AMI) Clinical Trial

— CR-2280  

Official title:

Risk Stratification for Sudden Cardiac Death After Acute Myocardial Infarction by Measuring Left Ventricular Volume Scar With Cardiac MRI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03725826
• Other study ID #: 13-01-023
• Status: Completed
• Start date: May 2013
• Est. completion date: September 2016

Study information

• Verified date: October 2018
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Myocardial Infarction (AMI)
• Death, Sudden, Cardiac
• Infarction
• Myocardial Infarction

Locations

Country	Name	City	State
United States	Montefiore Medical Center, Albert Einstein College of Medicine	Bronx	New York

Sponsors (2)

Lead Sponsor	Collaborator
Montefiore Medical Center	Medtronic

Country where clinical trial is conducted

United States, 

References & Publications (22)

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* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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
Secondary	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
Secondary	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 40 days post-MI
Secondary	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
Secondary	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
Secondary	Sustained ventricular fibrillation (VF)	Sustained ventricular fibrillation is malignant arrhythmia	At 40 days post-MI
Secondary	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
Secondary	Sustained ventricular fibrillation (VF)	Sustained ventricular fibrillation is malignant arrhythmia	At 3 months post-MI