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MRI of Myocardial Infarction (MRIMI)

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ClinicalTrials.gov Identifier: NCT03531151
Recruitment Status : Recruiting
First Posted : May 21, 2018
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

Study Description
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Brief Summary:
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.

Condition or disease
Myocardial Infarction Myocardial Ischemia Myocardial Injury Myocardial Fibrosis Myocardial Reperfusion Injury Myocardial Edema Myocardial Necrosis Heart Failure Ischemic Heart Disease Ischemic Cardiomyopathy Hemorrhage

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Magnetic Resonance Imaging of Myocardial Infarction
Actual Study Start Date : April 1, 2018
Estimated Primary Completion Date : March 31, 2023
Estimated Study Completion Date : March 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. ejection fraction [ Time Frame: <36 hours to >6 months ]

Secondary Outcome Measures :
  1. relaxation times [ Time Frame: <36 hours to >6 months ]
  2. extracellular volume fraction [ Time Frame: <36 hours to >6 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03531151


Locations
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United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Walter R Witschey, PhD    215-662-2310    witschey@pennmedicine.upenn.edu   
Sponsors and Collaborators
University of Pennsylvania
More Information
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Additional Information:

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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03531151     History of Changes
Other Study ID Numbers: 827697
First Posted: May 21, 2018    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Diseases
Myocardial Infarction
Coronary Artery Disease
Coronary Disease
Cardiomyopathies
Myocardial Ischemia
Reperfusion Injury
Myocardial Reperfusion Injury
Ischemia
Infarction
 Hemorrhage
Necrosis
Wounds and Injuries
Cardiovascular Diseases
Pathologic Processes
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Postoperative Complications