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

Myocardial Infarction, Acute Clinical Trial

— T2 AMI MRI  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01796743
• Other study ID #: Shaftner T2 AMI MRI
• Secondary ID: 13-0049-01
• Status: Withdrawn
• Phase: N/A
• First received: February 14, 2013
• Last updated: February 6, 2017
• Start date: February 2013
• Est. completion date: December 2015

Study information

• Verified date: February 2017
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• Myocardial Infarction, Acute

Locations

Country	Name	City	State
United States	University of Arizona	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
University of Arizona

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Development of Cox survival models predicting short term outcomes in the study population.	Development 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.	2 years
Primary	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	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
Secondary	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
Secondary	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