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

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

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01796743
Acronym
T2 AMI MRI
Enrollment
0
Registered
2013-02-22
Start date
2013-02-28
Completion date
2015-12-31
Last updated
2017-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Infarction, Acute

Keywords

MRI, Double Inversion radial fast Spin Echo T2 mapping, Heart failure risk stratification, 30 day post hospitalization outcome

Brief summary

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

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.

Interventions

None listed

Sponsors

University of Arizona
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Correlation of the estimated infarct and jeopardized myocardium size on T2 MRI images, Delayed Enhancement MRI, and combined functional/Delayed Enhancement MRI.2 yearsT2 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

Secondary

MeasureTime frameDescription
Number of participants with regional wall motion abnormalities in greater than 2 segments on in-house echocardiogram and LVEF<50%.2 yearsT2 mapping data will be compared to other variables in a multivariable regression model predicting cardiac events (LV dysfunction (LVEF \<50%) on predischarge echocardiogram.
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 yearsCorrelation 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).
Correlation of the infarct and jeopardized myocardium size to clinical data2 yearsCorrelation 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

Other

MeasureTime frameDescription
Development of Cox survival models predicting short term outcomes in the study population.2 yearsDevelopment of Cox survival models predicting short term outcomes in the study population. NRI (net reclassification index) will be calculated to determine if patients could be reclassified to either lower or higher risk using a new methodology as compared to standard cardiac MRI or clinical data.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026