Condition or disease | Intervention/treatment |
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Aortic Dissection Aortic Diseases | Diagnostic Test: Magnetic Resonance Imaging (MRI) using ultrasmall super paramagnetic iron oxides (USPIOs) |
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).
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 : | March 31, 2022 |
Estimated Study Completion Date : | March 31, 2022 |
Group/Cohort | Intervention/treatment |
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Acute aortic dissection
stable patients with confirmed diagnosis of acute AD.
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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.
|
Ages Eligible for Study: | 40 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Inclusion Criteria:
Exclusion Criteria:
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 |
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 |
Study Chair: | Toru Suzuki, MD, PhD | University of Leicester |
Tracking Information | |||||||||
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First Submitted Date | May 7, 2019 | ||||||||
First Posted Date | May 14, 2019 | ||||||||
Last Update Posted Date | May 3, 2021 | ||||||||
Actual Study Start Date | September 11, 2019 | ||||||||
Estimated Primary Completion Date | March 31, 2022 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures |
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Original Primary Outcome Measures | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title | Magnetic Resonance Imaging (MRI) for Aortic Dissection to Visualise Inflammation | ||||||||
Official Title | Magnetic Resonance Imaging (MRI) for Aortic Dissection to Visualise Inflammation | ||||||||
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). | ||||||||
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 | ||||||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||||||
Biospecimen | Retention: Samples Without DNA Description:
Blood samples
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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. | ||||||||
Condition |
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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.
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Study Groups/Cohorts |
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status | Recruiting | ||||||||
Estimated Enrollment |
20 | ||||||||
Original Estimated Enrollment | Same as current | ||||||||
Estimated Study Completion Date | March 31, 2022 | ||||||||
Estimated Primary Completion Date | March 31, 2022 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 40 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts |
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Listed Location Countries | United Kingdom | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number | NCT03948555 | ||||||||
Other Study ID Numbers | 0688 | ||||||||
Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | University of Leicester | ||||||||
Study Sponsor | University of Leicester | ||||||||
Collaborators | Not Provided | ||||||||
Investigators |
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PRS Account | University of Leicester | ||||||||
Verification Date | April 2021 |