T2 Heart Mapping in AMI Population for the Prediction of Short Term Major Adverse Cardiovascular Events

Study Overview
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Brief Summary
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A novel Cardiac MRI sequence, developed by Dr. Maria Altbach (Double Inversion radial fast Spin Echo T2 mapping), has been tested clinically. It demonstrated a high sensitivity to the heart muscle swelling (edema) in different types of heart injury, including heart attacks. The investigators propose to use T2-Map methodology in patients with acute heart attacks and to compare value of this method with other clinical and imaging parameters in predicting short-term (30 day) clinical outcomes of these patients. If successful, the project will provide an effective risk-stratification tool to identify patients with heart attack as a result of atherosclerotic disease, who require more aggressive therapeutic approach and closer follow-up after initial hospitalization.

Detailed Description
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In the initial feasibility project, a novel Cardiac MRI sequence (Double Inversion radial fast Spin Echo T2 mapping)developed by Dr. Maria Altbach at the University of Arizona, has been tested clinically. It demonstrated a high sensitivity to the heart muscle swelling (edema) in different types of heart injury, including heart attacks. The investigators have successfully tested the reproducibility of the new method in a series of healthy volunteers. The Phase I study revealed a robust clinical performance of the T2-Map sequence in multiple cardiac disorders. Based on these promising results, presented on several international Cardiac Imaging meetings, the investigators propose to use T2-Map methodology in patients with acute heart attacks and to compare value of this method with other clinical and imaging parameters in predicting short-term (30 day) clinical outcomes of these patients. If successful, the project will provide an effective risk-stratification tool to identify patients with heart attack as a result of atherosclerotic disease, who require more aggressive therapeutic approach and closer follow-up after initial hospitalization.

Official Title
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T2 Mapping of the Heart in Acute MI Population for the Prediction of Short Term Major Adverse Cardiovascular Events

Conditions
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Myocardial Infarction, Acute

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: between 18 to 89 years old diagnosis of Acute MI clinically Exclusion Criteria: contraindications for contrast enhanced CMR acute congestive heart failure ventricular or atrial arrhythmias ongoing chest pain/unstable angina ECG changes suggestive of acute/ongoing ischemia hypotension with systolic blood pressure <100 mmHg severe hypertension despite therapy, with systolic BP>180 mmHg, Patients without a telephone number and/or address for follow up Patients with severe claustrophobia. Vulnerable populations, such as minors, pregnant women, prisoners, or cognitively impaired patients

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Controls<br>Age and gender matched controls ('control' group) with acute MI with similar degree of troponin elevation who are managed based solely on the basis of clinical or angiographic data alone. | |
| Cardiac MRI<br>Hospitalized patients with acute MI with a clinically-indicated CMR ordered will be enrolled. Data for T2 mapping will be added to the clinically prescribed cardiac MRI scan. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of the estimated infarct and jeopardized myocardium size on T2 MRI images, Delayed Enhancement MRI, and combined functional/Delayed Enhancement MRI. | T2 mapping has been tested clinically and demonstrated a high sensitivity to the heart muscle swelling (edema) in different types of heart injury, including heart attacks. This project will assess the estimated infarct and jeopardized myocardium size based on T2 Map as compared to Delayed Enhancement MRI, combined functional and Delayed Enhancement MRI, and clinical data of the patients | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with regional wall motion abnormalities in greater than 2 segments on in-house echocardiogram and LVEF<50%. | T2 mapping data will be compared to other variables in a multivariable regression model predicting cardiac events (LV dysfunction (LVEF <50%) on predischarge echocardiogram. | 2 years | 
| Correlation of the infarct and jeopardized myocardium size to outcome measures (recurrent chest pain, new heart attack, post-MI arrhythmias, heart failure, rehospitalization and death) 30 days post hospital discharge. | Correlation of the infarct and jeopardized myocardium size using the different modalities to to outcome measures (recurrent chest pain, new heart attack, post-MI arrhythmias, heart failure, rehospitalization and death). | 2 years | 
| Correlation of the infarct and jeopardized myocardium size to clinical data | Correlation of the infarct and jeopardized myocardium size to clinical data, including Age at hospitalization, Gender, Race; History of hypertension, Diabetes, Coronary Artery Disease, COPD, Right Ventrical Hypertrophy, Congestive Heart Failure, ventricular arrhythmia, syncope, sudden death, Chronic Kidney Disease, End Stage Renal Disease, Pulmonary Hypertension, Heart Surgery (CABG, valve, etc.), PCI (PTCA, stent), MI, cardiac cath, Hyperlipidemia, Smoking, Claudication, Systemic Disease, Other Pulmonary Disease; or Family History of Heart Disease | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MRI, Double Inversion radial fast Spin Echo T2 mapping, Heart failure risk stratification, 30 day post hospitalization outcome