T2 Mapping of the Heart in Acute MI Population for the Prediction of Short Term Major Adverse Cardiovascular Events
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Correlation of the estimated infarct and jeopardized myocardium size on T2 MRI images, Delayed Enhancement MRI, and combined functional/Delayed Enhancement MRI.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •between 18 to 89 years old
- •diagnosis of Acute MI
- •clinically
排除标准
- •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
结局指标
主要结局
Correlation of the estimated infarct and jeopardized myocardium size on T2 MRI images, Delayed Enhancement MRI, and combined functional/Delayed Enhancement MRI.
时间窗: 2 years
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
次要结局
- Number of participants with regional wall motion abnormalities in greater than 2 segments on in-house echocardiogram and LVEF<50%.(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.(2 years)
- Correlation of the infarct and jeopardized myocardium size to clinical data(2 years)