Clinical trial NCT01796743: T2 Heart Mapping in AMI Population for the Prediction of Short Term Major Adverse Cardiovascular Events
Official title: T2 Mapping of the Heart in Acute MI Population for the Prediction of Short Term Major Adverse Cardiovascular Events
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Myocardial Infarction, Acute
Keywords: MRI
Double Inversion radial fast Spin Echo T2 mapping
Heart failure risk stratification
30 day post hospitalization outcome
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2013-02-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients between 18 to 89 years in the University of Arizona Medical Center with chest pain/discomfort suggestive of acute coronary event, elevated cardiac troponin levels and/or positive ECG criteria for MI.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Correlation of the estimated infarct and jeopardized myocardium size on T2 MRI images, Delayed Enhancement MRI, and combined functional/Delayed Enhancement MRI.
timeFrame: 2 years
Secondary outcomes:
measure: Number of participants with regional wall motion abnormalities in greater than 2 segments on in-house echocardiogram and LVEF<50%.
timeFrame: 2 years
measure: 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.
timeFrame: 2 years
measure: Correlation of the infarct and jeopardized myocardium size to clinical data
timeFrame: 2 years
Other outcomes:
measure: Development of Cox survival models predicting short term outcomes in the study population.
timeFrame: 2 years
Locations:
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
Study officials:
affiliation: University of Arizona
name: Aiden Abidov, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: