Clinical trial NCT03647566: 18F Sodium Fluoride PET/CT in Acute Aortic Syndrome
Official title: 18F Sodium Fluoride PET/CT in Acute Aortic Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Aortic Syndrome
Aortic Dissection
Penetrating Aortic Ulcer
Intramural Hematoma
Keywords: sodium fluoride
positron emission tomography
computed tomography
acute aortic syndrome
aortic dissection
intramural haematoma
penetrating aortic ulcer
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
Collaborators: name: NHS Lothian
name: British Heart Foundation
First posted: 2018-08-27
Enrollment: 76
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: INCLUSION CRITERIA:

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

EXCLUSION CRITERIA:

* 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

Primary outcomes:
measure: Aortic diameter
timeFrame: 12 months
Secondary outcomes:
measure: 18F Sodium Fluoride uptake in the aorta
timeFrame: 12 months
measure: Hospital admissions
timeFrame: 24 months
measure: Surgical Intervention
timeFrame: 24 months
measure: Change in renal function
timeFrame: 24 months
measure: Short Form-12 (SF12) questionnaire score
timeFrame: 24 months
measure: Disease related survival
timeFrame: 24 months
measure: All-cause mortality
timeFrame: 24 months
Other outcomes:
measure: Co-localisation of 18F-Sodium Fluoride with histological changes in aortic tissue
timeFrame: 12 to 36 months
Locations:
city: Edinburgh
country: United Kingdom
facility: Royal Infirmary of Edinburgh
Study officials:
affiliation: University of Edinburgh
name: Maaz BJ Syed, MBChB MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.