NCT03948555

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2019

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 7, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 14, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

September 11, 2019

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
Last Updated

May 3, 2021

Status Verified

April 1, 2021

Enrollment Period

2.6 years

First QC Date

May 7, 2019

Last Update Submit

April 29, 2021

Conditions

Aortic DissectionAortic Diseases

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (2)

  • Timing

    Up to 36 hours

  • Localisation

    Up to 36 hours

Study Arms (2)

Acute aortic dissection

stable patients with confirmed diagnosis of acute AD.

Diagnostic Test: Magnetic Resonance Imaging (MRI) using ultrasmall super paramagnetic iron oxides (USPIOs)

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)

Interventions

Magnetic Resonance Imaging (MRI) using ultrasmall super paramagnetic iron oxides (USPIOs)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.

Acute aortic dissectionChronic aortic dissection

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Leicester

Leicester, LE3 9QP, United Kingdom

NOT YET RECRUITING

University Hospitals of Leicester NHS Trust

Leicester, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

Aortic DissectionAortic Diseases

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Dissection, Blood VesselAneurysmVascular DiseasesCardiovascular DiseasesAcute Aortic Syndrome

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Toru Suzuki, MD, PhD

    University of Leicester

    STUDY CHAIR

Central Study Contacts

Andrea Salzano, MD

CONTACT

+44 (0) 1162583041andrea.salzano@leicester.ac.uk

Toru Suzuki, MD, PhD

CONTACT

+44 (0)116 204 4741tsuzuki@leicester.ac.uk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2019

First Posted

May 14, 2019

Study Start

September 11, 2019

Primary Completion

March 31, 2022

Study Completion

March 31, 2022

Last Updated

May 3, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

GB(2)