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Completed

NCT Number: NCT03647566

18F Sodium Fluoride PET/CT in Acute Aortic Syndrome

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.

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Key information

Age range

25 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Royal Infirmary of Edinburgh

Edinburgh, EH16 4SA, United Kingdom

About this study

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.

Who can participate

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:

  • 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

Treatment and study plan

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

CT Aortic Angiogram

Diagnostic Test

CT scan to assess aortic morphology and contextualise PET scan

Aortic MRI

Diagnostic Test

Aortic MRI to assess aortic morphology and contextualise PET scan

Primary outcomes

  1. Aortic diameter

    Time frame: 12 months

    Maximum cross-sectional aortic diameter

Secondary outcomes

  1. 18F Sodium Fluoride uptake in the aorta

    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.

  2. Hospital admissions

    Time frame: 24 months

    The requirement for hospital admission

  3. Surgical Intervention

    Time frame: 24 months

    Requirement for surgical intervention during follow-up period

  4. Change in renal function

    Time frame: 24 months

    Creatinine change during the follow-up period

  5. Short Form-12 (SF12) questionnaire score

    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.

  6. Disease related survival

    Time frame: 24 months

    Disease related survival

  7. All-cause mortality

    Time frame: 24 months

    All-cause mortality

Other outcomes

  1. Co-localisation of 18F-Sodium Fluoride with histological changes in aortic tissue

    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.

Sponsors and collaborators

Lead sponsor

University of Edinburgh

Other

Collaborators

  • British Heart Foundation
  • NHS Lothian

Registry information

Acronym: FAASt

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Aug 27, 2018
Registry last updated
Mar 14, 2022

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.

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