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

February 6, 2017 updated by: University of Arizona

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85724
        • University of Arizona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 89 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of participants with regional wall motion abnormalities in greater than 2 segments on in-house echocardiogram and LVEF<50%.
Time Frame: 2 years
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
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
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
Correlation of the infarct and jeopardized myocardium size to clinical data
Time Frame: 2 years
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

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Development of Cox survival models predicting short term outcomes in the study population.
Time Frame: 2 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Arizona

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2013

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2015

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 14, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2013

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 22, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 8, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Shaftner T2 AMI MRI
  • 13-0049-01 (OTHER: U of A Human Subjects Protection Program)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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