MRIMI: MRI of Myocardial Infarction

Sponsor

University of Pennsylvania (Other)

Overall Status

Recruiting

CT.gov ID

NCT03531151

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Heart failure (HF) is an enormous health burden affecting approximately 5.1 million people in the US and is the cause of 250,000 deaths each year. Approximately 50% of HF is caused by myocardial ischemia and requires immediate restoration of coronary blood flow to the affected myocardium. However, the success of reperfusion is partly limited by intramyocardial hemorrhage, which is the deposition of intravascular material into the myocardium. Hemorrhagic reperfusion injury has high prevalence and patients have a much greater risk of adverse left ventricular remodeling, risk of fatal arrhythmia, impaired systolic function and are hospitalized at a greater rate. Recent magnetic resonance imaging techniques have improved assessment of reperfusion injury, however, the association between MRI contrasts and reperfusion injury is highly unclear, and lacks specificity to IMH. Improved imaging of IMH and accurate knowledge about its spatial and temporal evolution may be essential for delivery of optimal medical therapy in patients and critical to identify patients most at risk for adverse ventricular remodeling. The overall goal is to investigate the magnetic properties of hemorrhage and develop MRI techniques with improved specificity to hemorrhage. New MRI techniques permit noninvasive assessment of the magnetic susceptibility of tissues and can target tissue iron. Therefore, the investigators hypothesize that MRI imaging of myocardial magnetic susceptibility can map hemorrhagic myocardium. The investigators will perform a longitudinal observational study in patients after reperfusion injury to validate these methods, compare the methods with conventional MR contrasts and develop MR methods for imaging humans.

Condition or Disease	Intervention/Treatment	Phase
Myocardial Infarction Myocardial Ischemia Myocardial Injury Myocardial Fibrosis Myocardial Reperfusion Injury Myocardial Edema Myocardial Necrosis Heart Failure Ischemic Heart Disease Ischemic Cardiomyopathy Hemorrhage

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

70 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Magnetic Resonance Imaging of Myocardial Infarction

Actual Study Start Date :

Apr 1, 2018

Anticipated Primary Completion Date :

Mar 31, 2023

Anticipated Study Completion Date :

Mar 31, 2023

Outcome Measures

Primary Outcome Measures

ejection fraction [<36 hours to >6 months]

Secondary Outcome Measures

relaxation times [<36 hours to >6 months]
extracellular volume fraction [<36 hours to >6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Between the ages of 18 and 80
Patients must be able to read and understand English
Participants must sign the informed consent form
Elevated and delayed peak creatine kinase-MB and troponin I (cTnI) and troponin T (cTnT) in blood serum,
ST elevation detected on ECG

Exclusion Criteria:

contraindications to cardiac MRI, including claustrophobia
advanced renal disease (estimated glomerular filtration rate 30 mL/min) or hypersensitivity to gadolinium
presence of a cardiac pacemaker or implanted cardiac cardioverter defibrillator
pregnancy
personal or family history of hypertrophic cardiomyopathy
inability to provide informed consent
history of seizure disorder