Risk Stratification After Acute Myocardial Infarction With Cardiac MRI

NCT03725826 | Completed

• 1 other identifier: 13-01-023
• Study Type: observational
• Target: 57
• Locations: 1 country
• Sites: 1

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:
• 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
• 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.

Conditions

Acute Myocardial Infarction (AMI)

Keywords

Sudden Cardiac Death; Acute Myocardial Infarction; Implantable Cardioverter Defibrillator; Cardiac Magnetic Resonance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• LVEF less than 35%

  At 40 days post-MI

• Cardiovascular Mortality

  At 40 days post-MI

• Cardiovascular Mortality

  at 3 months post-MI

• Sustained ventricular tachycardia (VT)

  At 40 days post-MI

• Sustained ventricular fibrillation (VF)

  At 40 days post-MI

Other Outcomes (6)

• Repeated Emergency Department visits

  At 40 days post-MI

• Hospital admissions

  At 40 days post-MI

• All-cause mortality

  At 40 days post-MI

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Montefiore Medical Center: lead
• Medtronic: collaborator

Study Sites (1)

Montefiore Medical Center, Albert Einstein College of Medicine

The Bronx, New York, 10467, United States

Location

Related Publications (22)

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MeSH Terms

Conditions

Death, Sudden, Cardiac

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Cardiovascular Diseases; Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mario Garcia, M.D.

  Montefiore Medical Center/Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 2, 2014
• First Posted: October 31, 2018
• Study Start: May 1, 2013
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: October 31, 2018

Record last verified: 2018-10

Locations

US (1)