- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03531151
MRI of Myocardial Infarction (MRIMI)
September 4, 2025 updated by: University of Pennsylvania
Magnetic Resonance Imaging of Myocardial Infarction
Heart failure (HF) is an enormous health burden affecting approximately 5.1 million people in the US and is the cause of 250,000 deaths each year.
Approximately 50% of HF is caused by myocardial ischemia and requires immediate restoration of coronary blood flow to the affected myocardium.
However, the success of reperfusion is partly limited by intramyocardial hemorrhage, which is the deposition of intravascular material into the myocardium.
Hemorrhagic reperfusion injury has high prevalence and patients have a much greater risk of adverse left ventricular remodeling, risk of fatal arrhythmia, impaired systolic function and are hospitalized at a greater rate.
Recent magnetic resonance imaging techniques have improved assessment of reperfusion injury, however, the association between MRI contrasts and reperfusion injury is highly unclear, and lacks specificity to IMH.
Improved imaging of IMH and accurate knowledge about its spatial and temporal evolution may be essential for delivery of optimal medical therapy in patients and critical to identify patients most at risk for adverse ventricular remodeling.
The overall goal is to investigate the magnetic properties of hemorrhage and develop MRI techniques with improved specificity to hemorrhage.
New MRI techniques permit noninvasive assessment of the magnetic susceptibility of tissues and can target tissue iron.
Therefore, the investigators hypothesize that MRI imaging of myocardial magnetic susceptibility can map hemorrhagic myocardium.
The investigators will perform a longitudinal observational study in patients after reperfusion injury to validate these methods, compare the methods with conventional MR contrasts and develop MR methods for imaging humans.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
14
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
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania
-
-
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
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
The study population specific to this project are ST-elevated myocardial infarction (STEMI) patients being treated with reperfusion therapy.
Description
Inclusion Criteria:
- Between the ages of 18 and 80
- Patients must be able to read and understand English
- Participants must sign the informed consent form
- Elevated and delayed peak creatine kinase-MB and troponin I (cTnI) and troponin T (cTnT) in blood serum,
- ST elevation detected on ECG
Exclusion Criteria:
- contraindications to cardiac MRI, including claustrophobia
- advanced renal disease (estimated glomerular filtration rate 30 mL/min) or hypersensitivity to gadolinium
- presence of a cardiac pacemaker or implanted cardiac cardioverter defibrillator
- pregnancy
- personal or family history of hypertrophic cardiomyopathy
- inability to provide informed consent
- history of seizure disorder
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
ejection fraction
Time Frame: <36 hours to >6 months
|
<36 hours to >6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
relaxation times
Time Frame: <36 hours to >6 months
|
<36 hours to >6 months
|
|
extracellular volume fraction
Time Frame: <36 hours to >6 months
|
<36 hours to >6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Actual)
April 1, 2018
Primary Completion (Actual)
March 31, 2025
Study Completion (Actual)
March 31, 2025
Study Registration Dates
First Submitted
May 8, 2018
First Submitted That Met QC Criteria
May 8, 2018
First Posted (Actual)
May 21, 2018
Study Record Updates
Last Update Posted (Estimated)
September 8, 2025
Last Update Submitted That Met QC Criteria
September 4, 2025
Last Verified
September 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Vascular Diseases
- Cardiovascular Diseases
- Postoperative Complications
- Pathologic Processes
- Heart Diseases
- Infarction
- Necrosis
- Cardiomyopathies
- Ischemia
- Reperfusion Injury
- Pathological Conditions, Signs and Symptoms
- Heart Failure
- Myocardial Ischemia
- Hemorrhage
- Myocardial Infarction
- Myocardial Reperfusion Injury
Other Study ID Numbers
- 827697
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.