18F Sodium Fluoride PET/CT in Acute Aortic Syndrome

Completed

• Conditions: Penetrating Aortic Ulcer; Acute Aortic Syndrome; Intramural Hematoma; Aortic Dissection
• Interventions: Diagnostic Test: 18F Sodium Fluoride Positron Emission Tomography / Computed Tomography; Diagnostic Test: Aortic MRI; Diagnostic Test: CT Aortic Angiogram

• Registration Number: NCT03647566
• Lead Sponsor: University of Edinburgh

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.

Study Timeline

• Study First Submitted: 2018-04-11
• Study First Submitted QC: 2018-08-23
• Study First Posted: 2018-08-27
• Study Start: 2018-10-01
• Status Verified: 2020-04
• Primary Completion: 2021-02-01
• Study Completion: 2021-02-01
• Last Update Submitted: 2022-03-11
• Last Update Posted: 2022-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
No Aortic Disease	Aortic MRI	Participants with normal calibre aortae and no prior diagnosis of acute aortic syndrome
Acute Aortic Syndrome	CT Aortic Angiogram	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	18F Sodium Fluoride Positron Emission Tomography / Computed Tomography	Participants with an established diagnosis of acute aortic syndrome.
Chronic Aortic Disease	CT Aortic Angiogram	Participants with an established diagnosis of acute aortic syndrome.
No Aortic Disease	18F Sodium Fluoride Positron Emission Tomography / Computed Tomography	Participants with normal calibre aortae and no prior diagnosis of acute aortic syndrome
Acute Aortic Syndrome	18F Sodium Fluoride Positron Emission Tomography / Computed Tomography	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.

Primary Outcome Measures

Name	Time	Method
Aortic diameter	12 months	Maximum cross-sectional aortic diameter

Secondary Outcome Measures

Name	Time	Method
Disease related survival	24 months	Disease related survival
Short Form-12 (SF12) questionnaire score	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.
Hospital admissions	24 months	The requirement for hospital admission
Change in renal function	24 months	Creatinine change during the follow-up period
Surgical Intervention	24 months	Requirement for surgical intervention during follow-up period
18F Sodium Fluoride uptake in the aorta	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.
All-cause mortality	24 months	All-cause mortality

Trial Locations

Locations (1)

Royal Infirmary of Edinburgh; 🇬🇧 Edinburgh, United Kingdom