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18F Sodium Fluoride PET/CT in Acute Aortic Syndrome (FAASt)

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ClinicalTrials.gov Identifier: NCT03647566
Recruitment Status : Recruiting
First Posted : August 27, 2018
Last Update Posted : October 30, 2018
Sponsor:
Collaborators:
NHS Lothian
British Heart Foundation
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Acute Aortic Syndrome Aortic Dissection Penetrating Aortic Ulcer Intramural Hematoma Diagnostic Test: 18F Sodium Fluoride Positron Emission Tomography / Computed Tomography Diagnostic Test: CT Aortic Angiogram Diagnostic Test: Aortic MRI

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.


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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 18F Sodium Fluoride PET/CT in Acute Aortic Syndrome
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
PET scan using the 18F-Sodium Fluoride radiotracer followed by an attenuation correction CT scan

Diagnostic Test: Aortic MRI
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.
Diagnostic Test: 18F Sodium Fluoride Positron Emission Tomography / Computed Tomography
PET scan using the 18F-Sodium Fluoride radiotracer followed by an attenuation correction CT scan

Diagnostic Test: CT Aortic Angiogram
CT scan to assess aortic morphology and contextualise PET scan

Chronic Aortic Disease
Participants with an established diagnosis of acute aortic syndrome.
Diagnostic Test: 18F Sodium Fluoride Positron Emission Tomography / Computed Tomography
PET scan using the 18F-Sodium Fluoride radiotracer followed by an attenuation correction CT scan

Diagnostic Test: CT Aortic Angiogram
CT scan to assess aortic morphology and contextualise PET scan




Primary Outcome Measures :
  1. Aortic diameter [ Time Frame: 12 months ]
    Maximum cross-sectional aortic diameter


Secondary Outcome Measures :
  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 Outcome Measures:
  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.


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


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Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03647566


Contacts
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Contact: Maaz BJ Syed, MBChB MSc 7896701386 maaz.syed@ed.ac.uk
Contact: David E Newby, BA BSc PhD 1312421000 d.e.newby@ed.ac.uk

Locations
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United Kingdom
Royal Infirmary of Edinburgh Recruiting
Edinburgh, United Kingdom, EH16 4SA
Contact: Maaz BJ Syed, MBChB MSc    07896701386    maaz.syed@ed.ac.uk   
Contact: David E Newby, BA BSc PhD    01312421000    d.e.newby@ed.ac.uk   
Principal Investigator: Maaz BJ Syed, MBChB MSc         
Principal Investigator: David E Newby, BA BSc PhD         
Sponsors and Collaborators
University of Edinburgh
NHS Lothian
British Heart Foundation
Investigators
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Principal Investigator: Maaz BJ Syed, MBChB MSc University of Edinburgh and NHS Lothian

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Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT03647566     History of Changes
Other Study ID Numbers: AC18044
First Posted: August 27, 2018    Key Record Dates
Last Update Posted: October 30, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data will not be shared outside the current research group

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Edinburgh:
sodium fluoride
positron emission tomography
computed tomography
acute aortic syndrome
aortic dissection
intramural haematoma
penetrating aortic ulcer

Additional relevant MeSH terms:
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Syndrome
Hematoma
Aneurysm, Dissecting
Disease
Pathologic Processes
Hemorrhage
Aneurysm
Vascular Diseases
Cardiovascular Diseases
Fluorides
Sodium Fluoride
Listerine
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents