Magnetic Resonance Imaging (MRI) for Aortic Dissection to Visualise Inflammation
NCT ID: NCT03948555
Last Updated: 2021-05-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
20 participants
OBSERVATIONAL
2019-09-11
2022-03-31
Brief Summary
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Detailed Description
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The underlying mechanism of the condition has, until recently, remained unclear. The Pi of the present sutdy has shed light on a mechanism that shows that inflammation underlies the condition. The PI of the present study has showed that inflammation in the aorta is triggered by macrophage infiltration into the aortic wall in both pre-clinical models using animal models of the condition (murine) and in patient tissue samples obtained at time of surgery.
Macrophage infiltration into the aortic wall, as a result of activation of the cytokine, granulocyte-macrophage colony stimulating factor (GM-CSF), is the trigger for an inflammatory cascade that is presently understood to underlie the pathogenic mechanism of the condition
Non-invasive assessment of macrophage infiltration would prove that this pathogenic mechanism exists (proof-of-concept). Macrophage infiltration has been shown to be feasible by contrast-enhanced Magnetic Resonance Imaging (MRI) using ultrasmall super paramagnetic iron oxides (USPIOs).
The hypothesis of the present study is that macrophage-mediated inflammation can be visualised in the aorta of patients with AD using the USPIO-enhanced MRI technique, and use the present study to confirm this (proof-of-concept).
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Acute aortic dissection
stable patients with confirmed diagnosis of acute AD.
Magnetic Resonance Imaging (MRI) using ultrasmall super paramagnetic iron oxides (USPIOs)
All patients will undergo two MRI scans (one MRI scan pre-USPIO administration, and one MRI scan 24-36 hours following USPIO administration) and blood samples will be taken for future biomarker analysis.
Chronic aortic dissection
patients with diagnosis of chronic AD, being followed up in outpatient aortic clinic.
Magnetic Resonance Imaging (MRI) using ultrasmall super paramagnetic iron oxides (USPIOs)
All patients will undergo two MRI scans (one MRI scan pre-USPIO administration, and one MRI scan 24-36 hours following USPIO administration) and blood samples will be taken for future biomarker analysis.
Interventions
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Magnetic Resonance Imaging (MRI) using ultrasmall super paramagnetic iron oxides (USPIOs)
All patients will undergo two MRI scans (one MRI scan pre-USPIO administration, and one MRI scan 24-36 hours following USPIO administration) and blood samples will be taken for future biomarker analysis.
Eligibility Criteria
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Inclusion Criteria
* Able and willing to comply with all study requirements.
* Age \> 40 years (Patients under the age of 40 years will not be included as they may have a connective tissue disorder accounting for their condition)
* Able and willing to give informed consent
* An adequate understanding of written and verbal English
Exclusion Criteria
* Renal failure (estimated glomerular filtration rate \< 30ml/min)
* Contraindication to MRI
* Known allergy to iron-containing compounds
* Participants who have participated in another research study involving an investigational product in the past 12 weeks.
* Female participants who are pregnant or lactating.
* Unwilling or unable to give informed consent
40 Years
ALL
No
Sponsors
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University of Leicester
OTHER
Responsible Party
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Principal Investigators
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Toru Suzuki, MD, PhD
Role: STUDY_CHAIR
University of Leicester
Locations
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University of Leicester
Leicester, , United Kingdom
University Hospitals of Leicester NHS Trust
Leicester, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Prof Suzuki
Role: primary
Other Identifiers
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0688
Identifier Type: -
Identifier Source: org_study_id
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