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

University of Arizona logo

University of Arizona

Status

Withdrawn

Conditions

Myocardial Infarction, Acute

Study type

Observational

Funder types

Other

Identifiers

NCT01796743
Shaftner T2 AMI MRI
13-0049-01 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18 to 89 years old

Volunteers

No Healthy Volunteers

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

Trial design

0 participants in 2 patient groups

Controls
Description:
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
Description:
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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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