Clinical Trials Directory

Trials / Unknown

UnknownNCT03948555

Magnetic Resonance Imaging (MRI) for Aortic Dissection to Visualise Inflammation

Status
Unknown
Phase
Study type
Observational
Enrollment
20 (estimated)
Sponsor
University of Leicester · Academic / Other
Sex
All
Age
40 Years
Healthy volunteers
Not accepted

Summary

The study is a single-centre, prospective, observational cross-sectional imaging study aimed to determine if macrophage-mediated inflammation can be visualised in the aorta of patients with aortic dissection (AD) using ultrasmall super paramagnetic iron oxides (USPIO)-enhanced magnetic resonance imaging (MRI).

Detailed description

Aortic dissection (AD) is a condition in which a disruption of the medial layer (in most cases provoked by a tear or an ulcer in the intima) results in separation of the aortic wall layers, with concomitant 'false lumen' formation and malperfusion of end organs. 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

Interventions

TypeNameDescription
DIAGNOSTIC_TESTMagnetic 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.

Timeline

Start date
2019-09-11
Primary completion
2022-03-31
Completion
2022-03-31
First posted
2019-05-14
Last updated
2021-05-03

Locations

2 sites across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT03948555. Inclusion in this directory is not an endorsement.