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

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ClinicalTrials.gov Identifier: NCT03948555
Recruitment Status : Recruiting
First Posted : May 14, 2019
Last Update Posted : January 29, 2020
Sponsor:
Information provided by (Responsible Party):
University of Leicester

Brief 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).

Condition or disease Intervention/treatment
Aortic Dissection Aortic Diseases Diagnostic Test: Magnetic Resonance Imaging (MRI) using ultrasmall super paramagnetic iron oxides (USPIOs)

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).

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Magnetic Resonance Imaging (MRI) for Aortic Dissection to Visualise Inflammation
Actual Study Start Date : September 11, 2019
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Acute aortic dissection
stable patients with confirmed diagnosis of acute AD.
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.

Chronic aortic dissection
patients with diagnosis of chronic AD, being followed up in outpatient aortic clinic.
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.




Primary Outcome Measures :
  1. Visualisation of inflammation [ Time Frame: Up to 36 hours ]
    To determine if macrophage-mediated inflammation can be visualised in the aorta of patients with aortic dissection using USPIO-enhanced MRI

  2. Feasibility [ Time Frame: Up to 36 hours ]
    To establish the feasibility of imaging macrophage-mediated inflammation in the aorta of patients with aortic dissection, using USPIO-enhanced MRI.


Secondary Outcome Measures :
  1. Timing [ Time Frame: Up to 36 hours ]
    To determine the timing of macrophage infiltration in aortic dissection (acute or chronic phase)

  2. Localisation [ Time Frame: Up to 36 hours ]
    To assess if macrophage mediated inflammation is localised to the site of dissection and the surrounding aorta or more widespread in the vasculature.


Biospecimen Retention:   Samples Without DNA
Blood samples


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Acute patients will be identified in cardiologic inward, after that patients have been discharged from the coronary care unit at Glenfield Hospital, Leicester. Chronic patients will be identified from the aortic outpatient clinic at Glenfield Hospital.
Criteria

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

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): NCT03948555


Contacts
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Contact: Andrea Salzano, MD +44 (0) 1162583041 andrea.salzano@leicester.ac.uk
Contact: Toru Suzuki, MD, PhD +44 (0)116 204 4741 tsuzuki@leicester.ac.uk

Locations
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United Kingdom
University of Leicester Not yet recruiting
Leicester, United Kingdom, LE3 9QP
Contact: Andrea Salzano, MD       andrea.salzano@leicester.ac.uk   
Contact: Toru Suzuki, PhD       tsuzuki@leicester.ac.uk   
Sub-Investigator: Gerry P McCann, MD         
Sub-Investigator: Anvesha Singh, PhD         
University Hospitals of Leicester NHS Trust Recruiting
Leicester, United Kingdom
Contact: Prof Suzuki         
Sponsors and Collaborators
University of Leicester
Investigators
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Study Chair: Toru Suzuki, MD, PhD University of Leicester
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Responsible Party: University of Leicester
ClinicalTrials.gov Identifier: NCT03948555    
Other Study ID Numbers: 0688
First Posted: May 14, 2019    Key Record Dates
Last Update Posted: January 29, 2020
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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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Aneurysm, Dissecting
Aortic Diseases
Inflammation
Pathologic Processes
Aneurysm
Vascular Diseases
Cardiovascular Diseases