Skip to main content
OpenTrials
Completed

NCT Number: NCT03725826

Risk Stratification After Acute Myocardial Infarction With Cardiac MRI

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acute Myocardial Infarction (AMI) Cardiovascular Diseases Death Death, Sudden Death, Sudden, Cardiac Heart Arrest Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Montefiore Medical Center, Albert Einstein College of Medicine

The Bronx, New York, 10467, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Change in LVEF in post MI patients

    Time frame: 40 days post-MI and 3 months post-MI

    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.

Secondary outcomes

  1. LVEF less than 35%

    Time frame: At 40 days post-MI

    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.

  2. Cardiovascular Mortality

    Time frame: At 40 days post-MI

    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.

  3. Cardiovascular Mortality

    Time frame: at 3 months post-MI

    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.

  4. Sustained ventricular tachycardia (VT)

    Time frame: At 40 days post-MI

    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.

  5. Sustained ventricular fibrillation (VF)

    Time frame: At 40 days post-MI

    Sustained ventricular fibrillation is malignant arrhythmia

  6. Sustained ventricular tachycardia (VT)

    Time frame: At 3 months post-MI

    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.

  7. Sustained ventricular fibrillation (VF)

    Time frame: At 3 months post-MI

    Sustained ventricular fibrillation is malignant arrhythmia

Other outcomes

  1. Repeated Emergency Department visits

    Time frame: At 40 days post-MI

    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.

  2. Hospital admissions

    Time frame: At 40 days post-MI

    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.

  3. All-cause mortality

    Time frame: At 40 days post-MI

    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.

  4. Cardiac death

    Time frame: At 40 days post-MI

    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.

  5. non-fatal myocardial infarction

    Time frame: At 40 days post-MI

    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.

  6. Incidents of Stroke

    Time frame: At 40 days post-MI

    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.

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Collaborators

  • Medtronic

Registry information

Official study title

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

Acronym: CR-2280

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Oct 31, 2018
Registry last updated
Oct 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.