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| Name | Class |
|---|---|
| NHS Lothian | OTHER_GOV |
| British Heart Foundation | OTHER |
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The purpose of this study is to determine whether Sodium Fluoride imaging (using Positron Emission Tomography-Computed Tomography - PET-CT) is able to predict disease progression in acute aortic syndrome.
Acute Aortic Syndrome encompasses multiple aortopathies, including aortic dissection, intramural haematoma and penetrating aortic ulcers. Acute aortic syndrome has a three year mortality approaching 25%. To date, other than the initial aortic diameter, there are no accurate methods of establishing the risk of disease progression in patients with acute aortic syndrome.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No Aortic Disease | Participants with normal calibre aortae and no prior diagnosis of acute aortic syndrome |
| |
| 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. |
| |
| Chronic Aortic Disease | Participants with an established diagnosis of acute aortic syndrome. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 18F Sodium Fluoride Positron Emission Tomography / Computed Tomography | Diagnostic Test | PET scan using the 18F-Sodium Fluoride radiotracer followed by an attenuation correction CT scan |
| Measure | Description | Time Frame |
|---|---|---|
| Aortic diameter | Maximum cross-sectional aortic diameter | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 18F Sodium Fluoride uptake in the aorta | 18F Sodium Fluoride binding in the aorta will be measured from PET/CT scans performed at recruitment and at 12 months follow-up. Uptake will be quantified in Standardised Uptake Values and as a tissue to background ratios. | 12 months |
| Hospital admissions |
| Measure | Description | Time Frame |
|---|---|---|
| Co-localisation of 18F-Sodium Fluoride with histological changes in aortic tissue | Uptake of 18F-Sodium Fluoride will be identified on PET-CT scans that are acquired as part of the study visit. This will be compared with histological changes in aortic specimens obtained from participants undergoing open surgical repair. | 12 to 36 months |
INCLUSION CRITERIA:
Patients with Acute Aortic Syndrome or Chronic Aortic Disease:
Healthy Controls:
EXCLUSION CRITERIA:
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Participants with acute aortic syndrome will be recruited from emergency hospital admissions. Participants with chronic aortic disease will be recruited from out-patient clinics and thoracic aortic surveillance programmes. Healthy volunteers will be recruited from the national abdominal aortic aneurysm screening service and vascular out-patient department clinics.
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| Name | Affiliation | Role |
|---|---|---|
| Maaz BJ Syed, MBChB MSc | University of Edinburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Infirmary of Edinburgh | Edinburgh | EH16 4SA | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35798405 | Derived | 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. |
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Individual participant data will not be shared outside the current research group
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| ID | Term |
|---|---|
| D000094683 | Acute Aortic Syndrome |
| D000784 | Aortic Dissection |
| D000094667 | Penetrating Atherosclerotic Ulcer |
| ID | Term |
|---|---|
| D001018 | Aortic Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000094665 | Dissection, Blood Vessel |
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| ID | Term |
|---|---|
| D014057 | Tomography, X-Ray Computed |
| ID | Term |
|---|---|
| D007090 | Image Interpretation, Computer-Assisted |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Aortic tissue specimens obtained from individuals undergoing open surgical repair will be studied histologically, using autoradiography and micro-PET/CT
| CT Aortic Angiogram | Diagnostic Test | CT scan to assess aortic morphology and contextualise PET scan |
|
| Aortic MRI | Diagnostic Test | Aortic MRI to assess aortic morphology and contextualise PET scan |
|
The requirement for hospital admission |
| 24 months |
| Surgical Intervention | Requirement for surgical intervention during follow-up period | 24 months |
| Change in renal function | Creatinine change during the follow-up period | 24 months |
| Short Form-12 (SF12) questionnaire score | The SF12 is a validated, self reported quality of life assessment questionnaire. It consists of 12 questions that measure functional and mental well-being. Scores range from 12 to 47. | 24 months |
| Disease related survival | Disease related survival | 24 months |
| All-cause mortality | All-cause mortality | 24 months |
| D000783 |
| Aneurysm |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D011856 | Radiographic Image Enhancement |
| D007089 | Image Enhancement |
| D010781 | Photography |
| D011859 | Radiography |
| D014056 | Tomography, X-Ray |
| D014054 | Tomography |