Royal Infirmary of Edinburgh
Edinburgh, EH16 4SA, United Kingdom
NCT Number: NCT03647566
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.
Looking for future studies?
Notify Me25 year and older
All sexes
Observational
Edinburgh, EH16 4SA, United Kingdom
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patients with Acute Aortic Syndrome or Chronic Aortic Disease:
Healthy Controls:
Exclusion criteria
PET scan using the 18F-Sodium Fluoride radiotracer followed by an attenuation correction CT scan
CT scan to assess aortic morphology and contextualise PET scan
Aortic MRI to assess aortic morphology and contextualise PET scan
Time frame: 12 months
Maximum cross-sectional aortic diameter
Time frame: 12 months
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.
Time frame: 24 months
The requirement for hospital admission
Time frame: 24 months
Requirement for surgical intervention during follow-up period
Time frame: 24 months
Creatinine change during the follow-up period
Time frame: 24 months
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.
Time frame: 24 months
Disease related survival
Time frame: 24 months
All-cause mortality
Time frame: 12 to 36 months
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.
University of Edinburgh
Other
Acronym: FAASt
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04430400
Acute Aortic Syndrome, Aneurysm
São Paulo, Brazil
View Trial DetailsNCT04711889
Acute Aortic Syndrome, Aortic Diseases
Nanjing, Jiangsu, China
View Trial DetailsNCT04751058
Acute Aortic Syndrome, Aortic Diseases
Seville, Andalusia, Spain
View Trial DetailsNCT01259843
Acute Aortic Syndrome, Aortic Diseases
View Trial Details