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| Name | Class |
|---|---|
| NHS Lothian | OTHER_GOV |
| NHS Greater Glasgow and Clyde | OTHER |
| NHS Lanarkshire | OTHER_GOV |
| NHS Tayside |
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The purpose of the study is to describe Sodium Fluoride uptake (using Positron Emission Tomography-Computed Tomography - PET-CT) following Endovascular Aneurysm Repair (EVAR) and to determine whether Sodium Fluoride PET-CT can predict the development of endoleaks.
Abdominal aortic aneurysms are a leading cause of death in the United Kingdom. Surveillance programmes and pre-emptive surgical repair are lifesaving. Traditional open surgical repair is associated with major perioperative morbidity and mortality and there has been a move towards minimally invasive Endovascular Aneurysm Repair (EVAR), which reduces these early risks. However, the cost effectiveness and long-term clinical effectiveness of EVAR is undermined by concerns of durability due to the development of endoleaks and late aneurysm rupture secondary to progression of native aortic aneurysm disease and stent graft failure. It has previously been demonstrated that 18F-Sodium Fluoride Positron Emission Tomography can predict progression of aneurysm disease and is associated with greater rates of abdominal aortic aneurysm expansion and the future risk of rupture or surgical repair.
The investigators here wish to examine whether 18F-Sodium Fluoride on Positron Emission Tomography uptake (i) is increased in patients with endoleaks or related complications, (ii) can prospectively predict the likelihood of developing endoleaks in patients undergoing EVAR, and (ii) is a feasible approach to select patients for EVAR with a reduced future risk of stent graft failure and re-intervention. The investigators believe that there is a compelling scientific rationale for this approach with major translational potential to better select subgroups of patients for EVAR and ultimately improve their outcome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endoleak Group | Participants with a previous Endovascular Aneurysm Repair (EVAR) who have developed an endoleak |
| |
| No Endoleak Group | Participants with a previous Endovascular Aneurysm Repair (EVAR) who have not developed an endoleak |
| |
| Pre-EVAR Group | Participants who have an abdominal aortic aneurysm and who are undergoing an Endovascular Aneurysm Repair as standard of care |
|
| 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 |
|---|---|---|
| Microcalcification activity in stented and aneurysmal aorta | Will be measured as 18F Sodium Fluoride binding in the aorta. Uptake will be quantified in Standardised Uptake Values and as a tissue to background ratios. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pattern of microcalcification activity in the stented aorta | Microcalcification activity | 12 months |
| Intensity of microcalcification activity in the stented aorta | Microcalcification activity |
| 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 if participant undergoes an open aortic procedure during the study period. | 12-36 months |
Inclusion Criteria:
Exclusion Criteria:
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The study population will consist of individuals with an abdominal aortic aneurysm (AAA). The first part of the study (Study 1 - Case Control Study) will recruit patients with existing EVAR in to two groups: patients that have an endoleak or related complication (endoleak group, n = 22) and those that have remained complication-free (no endoleak group, n = 22). We will also prospectively recruit patients who are yet to receive EVAR or fenestrated EVAR (pre-EVAR group, n = 100) for the (Study 2 - Cohort Study).
There will be four patient identification centres from which patients will be recruited: NHS Lothian, NHS Lanarkshire, NHS Greater Glasgow and Clyde, and NHS Tayside.
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| Name | Affiliation | Role |
|---|---|---|
| Samuel Debono | University of Edinburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ninewells Hospital | Dundee | DD2 1SG | United Kingdom | |||
| University Hospital Hairmyres |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37164479 | Result | Debono S, Nash J, Fletcher AJ, Syed M, van Beek EJR, Williams MC, Falah O, Tambyraja A, Dweck MR, Newby DE, Forsythe RO. Aortic sodium [18F]fluoride uptake following endovascular aneurysm repair. Heart. 2023 Oct 26;109(22):1677-1682. doi: 10.1136/heartjnl-2023-322514. | |
| 33674354 | Derived | Debono S, Nash J, Tambyraja AL, Newby DE, Forsythe RO. Endovascular repair for abdominal aortic aneurysms. Heart. 2021 Nov;107(22):1783-1789. doi: 10.1136/heartjnl-2020-318288. Epub 2021 Mar 4. |
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There are no plans for individual participant data sharing.
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| OTHER_GOV |
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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 |
|
| 12-month CT Aortic Angiogram | Diagnostic Test | CT scan to assess aortic morphology and the stent graft |
|
| 24-month review | Other | This will consist of a telephone consultation with the study participant and review of electronic clinical records |
|
| 12 months |
| Endoleaks | Computed tomography and ultrasound endpoints | 12 months |
| Stent graft migration | Computed tomography and ultrasound endpoints | 12 months |
| Aneurysm sac diameter | Computed tomography and ultrasound endpoints | 12 months |
| Neck diameter and neck angulation | Computed tomography and ultrasound endpoints | 12 months |
| Geometry: tortuosity, curvature, torsion | Computed tomography and ultrasound endpoints | 12 months |
| Aneurysm-related mortality | Clinical endpoints | 24 months |
| Re-intervention | Clinical endpoints | 24 months |
| All-cause mortality | Clinical endpoints | 24 months |
| East Kilbride |
| G75 8RG |
| United Kingdom |
| Royal Infirmary of Edinburgh | Edinburgh | EH16 4SB | United Kingdom |
| Queen Elizabeth University Hospital | Glasgow | G51 4TF | United Kingdom |
| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| D057867 | Endoleak |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001018 | Aortic Diseases |
| D019106 | Postoperative Hemorrhage |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
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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 |
| D011856 | Radiographic Image Enhancement |
| D007089 | Image Enhancement |
| D010781 | Photography |
| D011859 | Radiography |
| D014056 | Tomography, X-Ray |
| D014054 | Tomography |
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