Study Results
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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COMPLETED
76 participants
OBSERVATIONAL
2018-10-01
2021-02-01
Brief Summary
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Detailed Description
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In vascular disease, microcalcification occurs in response to necrotic inflammation. Using computed tomography and positron emission tomography (PET-CT), early microcalcification can be identified using uptake of the radiotracer 18F-sodium fluoride. This can identify high risk-lesions in the aorta, coronary and carotid arteries, and appears to be indicative of necrotic and heavily inflamed tissue. In abdominal aortic aneurysms, 18F-sodium fluoride binding predicts aortic expansion and the risk of aneurysm rupture or requirement for surgical repair.
The study investigators, therefore, propose to evaluate the ability of 18F-sodium fluoride to identify regions of necrotic inflammation in acute aortic syndrome to predict aortic expansion and disease progression.
Control patients with a normal calibre aorta will be recruited from the National Abdominal Aortic Aneurysm Screening Programme and Vascular Out-Patient Clinics. Patients with acute aortic syndrome and chronic aortic disease will undergo clinical assessments and 18F Sodium Fluoride PET/CT scans at baseline and 12-months. Clinical follow-up will continue for up to 3 years from recruitment.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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No Aortic Disease
Participants with normal calibre aortae and no prior diagnosis of acute aortic syndrome
18F Sodium Fluoride Positron Emission Tomography / Computed Tomography
PET scan using the 18F-Sodium Fluoride radiotracer followed by an attenuation correction CT scan
Aortic MRI
Aortic MRI to assess aortic morphology and contextualise PET scan
Acute Aortic Syndrome
Participants presenting acutely with a diagnosis of acute aortic syndrome as defined in the European Society of Cardiology guidelines: a compatible clinical presentation with CT or magnetic resonance imaging confirming acute aortic syndrome.
18F Sodium Fluoride Positron Emission Tomography / Computed Tomography
PET scan using the 18F-Sodium Fluoride radiotracer followed by an attenuation correction CT scan
CT Aortic Angiogram
CT scan to assess aortic morphology and contextualise PET scan
Chronic Aortic Disease
Participants with an established diagnosis of acute aortic syndrome.
18F Sodium Fluoride Positron Emission Tomography / Computed Tomography
PET scan using the 18F-Sodium Fluoride radiotracer followed by an attenuation correction CT scan
CT Aortic Angiogram
CT scan to assess aortic morphology and contextualise PET scan
Interventions
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18F Sodium Fluoride Positron Emission Tomography / Computed Tomography
PET scan using the 18F-Sodium Fluoride radiotracer followed by an attenuation correction CT scan
CT Aortic Angiogram
CT scan to assess aortic morphology and contextualise PET scan
Aortic MRI
Aortic MRI to assess aortic morphology and contextualise PET scan
Eligibility Criteria
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Inclusion Criteria
* A diagnosis of acute aortic syndrome as defined as per the European Society of Cardiology guidelines on the management of aortic disease a compatible clinical presentation with CT or magnetic resonance imaging confirming acute aortic syndrome.
* Adults over the age of 25 years
* Participants who have had previous open or thoracic endovascular aortic repair (TEVAR) are eligible to participate in the study.
Healthy Controls:
* No previous diagnosis of aortic disease
* Over the age of 55 years
Exclusion Criteria
* Chronic kidney disease (eGFR ≤ 30 mL/min/1.73 m2)
* Major or untreated cancer
* Pregnancy
* Allergy or contra-indication to iodinated contrast
* Inability or unwillingness to give informed consent
25 Years
ALL
Yes
Sponsors
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NHS Lothian
OTHER_GOV
British Heart Foundation
OTHER
University of Edinburgh
OTHER
Responsible Party
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Principal Investigators
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Maaz BJ Syed, MBChB MSc
Role: PRINCIPAL_INVESTIGATOR
University of Edinburgh
Locations
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Royal Infirmary of Edinburgh
Edinburgh, , United Kingdom
Countries
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References
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Syed MBJ, Fletcher AJ, Debono S, Forsythe RO, Williams MC, Dweck MR, Shah ASV, Macaskill MG, Tavares A, Denvir MA, Lim K, Wallace WA, Kaczynski J, Clark T, Sellers SL, Masson N, Falah O, Chalmers RTA, Tambyraja AL, van Beek EJR, Newby DE. 18F-Sodium Fluoride Positron Emission Tomography and Computed Tomography in Acute Aortic Syndrome. JACC Cardiovasc Imaging. 2022 Jul;15(7):1291-1304. doi: 10.1016/j.jcmg.2022.01.003. Epub 2022 Mar 16.
Other Identifiers
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AC18044
Identifier Type: -
Identifier Source: org_study_id
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