Acute Aortic SyndromeFAAStNCT03647566
18F Sodium Fluoride PET/CT in Acute Aortic Syndrome
An observational study of Acute Aortic Syndrome and Aortic Dissection, run by University of Edinburgh at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 25 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Aortic Syndrome, Aortic Dissection, Penetrating Aortic Ulcer
- What is being tested?
- 18F Sodium Fluoride Positron Emission Tomography / Computed Tomography, CT Aortic Angiogram and Aortic MRI
- How many people
- 76 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Oct 2018to 1 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- Patients with Acute Aortic Syndrome or Chronic Aortic Disease:
- 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
Who cannot join
- The inability of patients to undergo PET/CT scanning
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Being tested
- 18F Sodium Fluoride Positron Emission Tomography / Computed Tomography, CT Aortic Angiogram, Aortic MRI
- Keywords
- sodium fluoride, positron emission tomography, computed tomography, acute aortic syndrome, aortic dissection, intramural haematoma, penetrating aortic ulcer
- Medical subject headings
- Acute Aortic Syndrome, Aortic Dissection, Penetrating Atherosclerotic Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F Sodium Fluoride Positron Emission Tomography / Computed TomographyDiagnostic test
PET scan using the 18F-Sodium Fluoride radiotracer followed by an attenuation correction CT scan
CT Aortic AngiogramDiagnostic test
CT scan to assess aortic morphology and contextualise PET scan
Aortic MRIDiagnostic test
Aortic MRI to assess aortic morphology and contextualise PET scan
| Study group | Role | What they receive |
|---|---|---|
| No Aortic Disease | Participants with normal calibre aortae and no prior diagnosis of acute aortic syndrome Receives: Diagnostic Test: 18F Sodium Fluoride Positron Emission Tomography / Computed Tomography; Diagnostic Test: Aortic MRI | |
| 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. Receives: Diagnostic Test: 18F Sodium Fluoride Positron Emission Tomography / Computed Tomography; Diagnostic Test: CT Aortic Angiogram | |
| Chronic Aortic Disease | Participants with an established diagnosis of acute aortic syndrome. Receives: Diagnostic Test: 18F Sodium Fluoride Positron Emission Tomography / Computed Tomography; Diagnostic Test: CT Aortic Angiogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aortic diameter
Maximum cross-sectional aortic diameter
Measured: 12 months
Secondary outcomes (7)
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.
Measured: 12 months
Hospital admissions
The requirement for hospital admission
Measured: 24 months
Surgical Intervention
Requirement for surgical intervention during follow-up period
Measured: 24 months
Change in renal function
Creatinine change during the follow-up period
Measured: 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.
Measured: 24 months
Disease related survival
Disease related survival
Measured: 24 months
All-cause mortality
All-cause mortality
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2018
- Study start1 Oct 2018
- Primary completion1 Feb 2021
- Study completion1 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Aortic SyndromeStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Lothian, British Heart Foundation
- Responsible party
- Sponsor
- Investigators
- Maaz BJ Syed, MBChB MSc, Principal investigator, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03647566
- Sponsor's protocol ID
- AC18044
- Acronym
- FAASt
- Status last verified
- Apr 2020
- First submitted
- 11 Apr 2018
- Last updated
- 14 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared outside the current research group
Publications
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.
PubMed 35798405
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 18F Sodium Fluoride PET/CT in Acute Aortic Syndrome
- ClinicalTrials.gov ID
- NCT03647566
- Acronym / sponsor ID
- FAASt / AC18044
- Keywords
- sodium fluoride, positron emission tomography, computed tomography, acute aortic syndrome, aortic dissection, intramural haematoma, penetrating aortic ulcer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- NHS Lothian, British Heart Foundation
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 27 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No Aortic Disease | – | Diagnostic Test: 18F Sodium Fluoride Positron Emission Tomography / Computed Tomography, Diagnostic Test: Aortic MRIParticipants with normal calibre aortae and no prior diagnosis of acute aortic syndrome |
| Acute Aortic Syndrome | – | Diagnostic Test: 18F Sodium Fluoride Positron Emission Tomography / Computed Tomography, Diagnostic Test: CT Aortic AngiogramParticipants 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 | – | Diagnostic Test: 18F Sodium Fluoride Positron Emission Tomography / Computed Tomography, Diagnostic Test: CT Aortic AngiogramParticipants with an established diagnosis of acute aortic syndrome. |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (7 listed)
- 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.
- No previous diagnosis of aortic disease
- Over the age of 55 years
Key exclusion criteria (6 listed)
- The inability of patients to undergo PET/CT scanning
- Chronic kidney disease (eGFR ≤ 30 mL/min/1.73 m2)
- Major or untreated cancer
- Pregnancy
- Allergy or contra-indication to iodinated contrast
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F Sodium Fluoride Positron Emission Tomography / Computed TomographyPET scan using the 18F-Sodium Fluoride radiotracer followed by an attenuation correction CT scan | Diagnostic test | Acute Aortic Syndrome, Chronic Aortic Disease, No Aortic Disease |
| CT Aortic AngiogramCT scan to assess aortic morphology and contextualise PET scan | Diagnostic test | Acute Aortic Syndrome, Chronic Aortic Disease |
| Aortic MRIAortic MRI to assess aortic morphology and contextualise PET scan | Diagnostic test | No Aortic Disease |
Primary outcome
Aortic diameter
Time frame: 12 months
Maximum cross-sectional aortic diameter
7 secondary outcomes
18F Sodium Fluoride uptake in the aorta
Time frame: 12 months
Hospital admissions
Time frame: 24 months
Surgical Intervention
Time frame: 24 months
Change in renal function
Time frame: 24 months
Short Form-12 (SF12) questionnaire score
Time frame: 24 months
Disease related survival
Time frame: 24 months
All-cause mortality
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2022.
- Derived from this study: PubMed 35798405Syed 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.
- Individual participant dataSharing planned: No. Individual participant data will not be shared outside the current research group
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maaz BJ Syed, MBChB MSc principal investigator
University of Edinburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Aortic Syndrome and Aortic Dissection, run by University of Edinburgh at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aortic diameter (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03647566, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2022; AzTrials last refreshed its copy on 6 Nov 2026.