18F Sodium Fluoride PET/CT in Acute Aortic Syndrome

NCT ID: NCT03647566

Last Updated: 2022-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

76 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-01

Study Completion Date

2021-02-01

Brief Summary

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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

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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.

Conditions

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Acute Aortic Syndrome Aortic Dissection Penetrating Aortic Ulcer Intramural Hematoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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No Aortic Disease

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

18F Sodium Fluoride Positron Emission Tomography / Computed Tomography

Intervention Type DIAGNOSTIC_TEST

PET scan using the 18F-Sodium Fluoride radiotracer followed by an attenuation correction CT scan

Aortic MRI

Intervention Type DIAGNOSTIC_TEST

Aortic MRI to assess aortic morphology and contextualise PET scan

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.

18F Sodium Fluoride Positron Emission Tomography / Computed Tomography

Intervention Type DIAGNOSTIC_TEST

PET scan using the 18F-Sodium Fluoride radiotracer followed by an attenuation correction CT scan

CT Aortic Angiogram

Intervention Type DIAGNOSTIC_TEST

CT scan to assess aortic morphology and contextualise PET scan

Chronic Aortic Disease

Participants with an established diagnosis of acute aortic syndrome.

18F Sodium Fluoride Positron Emission Tomography / Computed Tomography

Intervention Type DIAGNOSTIC_TEST

PET scan using the 18F-Sodium Fluoride radiotracer followed by an attenuation correction CT scan

CT Aortic Angiogram

Intervention Type DIAGNOSTIC_TEST

CT scan to assess aortic morphology and contextualise PET scan

Interventions

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18F Sodium Fluoride Positron Emission Tomography / Computed Tomography

PET scan using the 18F-Sodium Fluoride radiotracer followed by an attenuation correction CT scan

Intervention Type DIAGNOSTIC_TEST

CT Aortic Angiogram

CT scan to assess aortic morphology and contextualise PET scan

Intervention Type DIAGNOSTIC_TEST

Aortic MRI

Aortic MRI to assess aortic morphology and contextualise PET scan

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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NHS Lothian

OTHER_GOV

Sponsor Role collaborator

British Heart Foundation

OTHER

Sponsor Role collaborator

University of Edinburgh

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maaz BJ Syed, MBChB MSc

Role: PRINCIPAL_INVESTIGATOR

University of Edinburgh

Locations

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Royal Infirmary of Edinburgh

Edinburgh, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 35798405 (View on PubMed)

Other Identifiers

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AC18044

Identifier Type: -

Identifier Source: org_study_id

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