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

Aortic Dissection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03948555
• Other study ID #: 0688
• Status: Recruiting
• Start date: September 11, 2019
• Est. completion date: March 31, 2022

Study information

• Verified date: April 2021
• Source: University of Leicester
• Contact: Andrea Salzano, MD
• Phone: +44 (0) 1162583041
• Email: andrea.salzano[@]leicester.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 31, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Confirmed diagnosis of acute or chronic aortic dissection (>2 week after initial intimal injury)

• 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:

• Past history of systemic iron overload or haemochromatosis

• 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

Related Conditions & MeSH terms

• Aneurysm, Dissecting
• Aortic Diseases
• Aortic Dissection
• Inflammation

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
United Kingdom	University Hospitals of Leicester NHS Trust	Leicester
United Kingdom	University of Leicester	Leicester

Sponsors (1)

Lead Sponsor	Collaborator
University of Leicester

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visualisation of inflammation	To determine if macrophage-mediated inflammation can be visualised in the aorta of patients with aortic dissection using USPIO-enhanced MRI	Up to 36 hours
Primary	Feasibility	To establish the feasibility of imaging macrophage-mediated inflammation in the aorta of patients with aortic dissection, using USPIO-enhanced MRI.	Up to 36 hours
Secondary	Timing	To determine the timing of macrophage infiltration in aortic dissection (acute or chronic phase)	Up to 36 hours
Secondary	Localisation	To assess if macrophage mediated inflammation is localised to the site of dissection and the surrounding aorta or more widespread in the vasculature.	Up to 36 hours