18F Sodium Fluoride PET/CT in Acute Aortic Syndrome

NCT03647566 | Completed

• 1 other identifier: AC18044
• Study Type: observational
• Target: 76
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Aortic diameter

  Maximum cross-sectional aortic diameter

  12 months

Secondary Outcomes (7)

• 18F Sodium Fluoride uptake in the aorta

  12 months

• Hospital admissions

  24 months

• Surgical Intervention

  24 months

• Change in renal function

  24 months

• Short Form-12 (SF12) questionnaire score

  24 months

Other Outcomes (1)

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

  12 to 36 months

Study Arms (3)

No Aortic Disease

Participants with normal calibre aortae and no prior diagnosis of acute aortic syndrome

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.

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.

Diagnostic Test: 18F Sodium Fluoride Positron Emission Tomography / Computed Tomography; Diagnostic Test: CT Aortic Angiogram

Interventions

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

Acute Aortic Syndrome; Chronic Aortic Disease; No Aortic Disease

CT Aortic Angiogram DIAGNOSTIC_TEST

CT scan to assess aortic morphology and contextualise PET scan

Acute Aortic Syndrome; Chronic Aortic Disease

Aortic MRI DIAGNOSTIC_TEST

Aortic MRI to assess aortic morphology and contextualise PET scan

No Aortic Disease

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Edinburgh: lead
• NHS Lothian: collaborator
• British Heart Foundation: collaborator

Study Sites (1)

Royal Infirmary of Edinburgh

Edinburgh, EH16 4SA, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 35798405 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Aortic tissue specimens obtained from individuals undergoing open surgical repair will be studied histologically, using autoradiography and micro-PET/CT

MeSH Terms

Conditions

Acute Aortic Syndrome; Aortic Dissection; Penetrating Atherosclerotic Ulcer

Interventions

Tomography, X-Ray Computed

Condition Hierarchy (Ancestors)

Aortic Diseases; Vascular Diseases; Cardiovascular Diseases; Dissection, Blood Vessel; Aneurysm; Arteriosclerosis; Arterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography

Study Officials

• Maaz BJ Syed, MBChB MSc

  University of Edinburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2018
• First Posted: August 27, 2018
• Study Start: October 1, 2018
• Primary Completion: February 1, 2021
• Study Completion: February 1, 2021
• Last Updated: March 14, 2022

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)