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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2013 by University of Arizona
Sponsor:
Collaborator:
University of Arizona Sarver Heart Center
Information provided by (Responsible Party):
University of Arizona
ClinicalTrials.gov Identifier:
NCT01796743
First received: February 14, 2013
Last updated: June 3, 2013
Last verified: June 2013
  Purpose

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.


Condition
Myocardial Infarction, Acute

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: T2 Mapping of the Heart in Acute MI Population for the Prediction of Short Term Major Adverse Cardiovascular Events

Resource links provided by NLM:


Further study details as provided by University of Arizona:

Primary Outcome Measures:
  • Correlation of the estimated infarct and jeopardized myocardium size on T2 MRI images, Delayed Enhancement MRI, and combined functional/Delayed Enhancement MRI. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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 Enhancment MRI, combined functional and Delayed Enhancement MRI, and clinical data of the patients


Secondary Outcome Measures:
  • Number of participants with regional wall motion abnormalities in greater than 2 segments on in-house echocardiogram and LVEF<50%. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    T2 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. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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).

  • Correlation of the infarct and jeopardized myocardium size to clinical data [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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


Other Outcome Measures:
  • Development of Cox survival models predicting short term outcomes in the study population. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 75
Study Start Date: June 2013
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Controls
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
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.

Detailed Description:

In our 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. Our 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

Ages Eligible for Study:   18 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01796743

Locations
United States, Arizona
University of Arizona Not yet recruiting
Tucson, Arizona, United States, 85724
Contact: Aiden Abidov, MD, PhD    520-626-3766    aabidov@shc.arizona.edu   
Principal Investigator: Aiden Abidov, MD, PhD         
Sub-Investigator: Jaspreet Singh, MD         
Sponsors and Collaborators
University of Arizona
University of Arizona Sarver Heart Center
Investigators
Principal Investigator: Aiden Abidov, MD, PhD University of Arizona
  More Information

No publications provided

Responsible Party: University of Arizona
ClinicalTrials.gov Identifier: NCT01796743     History of Changes
Other Study ID Numbers: Shaftner T2 AMI MRI, 13-0049-01
Study First Received: February 14, 2013
Last Updated: June 3, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Arizona:
MRI
Double Inversion radial fast Spin Echo T2 mapping
Heart failure risk stratification
30 day post hospitalization outcome

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on August 28, 2014