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

NCT ID: NCT03948555

Last Updated: 2021-05-03

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-11

Study Completion Date

2022-03-31

Brief Summary

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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

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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

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Aortic Dissection Aortic Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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)

Intervention Type DIAGNOSTIC_TEST

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)

Intervention Type DIAGNOSTIC_TEST

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Leicester

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status NOT_YET_RECRUITING

University Hospitals of Leicester NHS Trust

Leicester, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Andrea Salzano, MD

Role: CONTACT

+44 (0) 1162583041

Toru Suzuki, MD, PhD

Role: CONTACT

+44 (0)116 204 4741

Facility Contacts

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Andrea Salzano, MD

Role: primary

Toru Suzuki, PhD

Role: backup

Prof Suzuki

Role: primary

Other Identifiers

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0688

Identifier Type: -

Identifier Source: org_study_id

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