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Trial record 18 of 291 for:    Sodium Fluoride OR Duraphat

Assessment of Risk in Thoracic Aortopathy Using 18F-Sodium Fluoride (AoRTAS)

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ClinicalTrials.gov Identifier: NCT04083118
Recruitment Status : Recruiting
First Posted : September 10, 2019
Last Update Posted : September 10, 2019
Sponsor:
Information provided by (Responsible Party):
University of Edinburgh

Brief Summary:
Patients with bicuspid aortic valve-related aortopathy are at increased risk of aortic dilatation, dissection and rupture. Currently, risk stratification is largely based on aortic diameter measurements, with those deemed high risk referred for aortic replacement surgery. This approach is imperfect, and potentially exposes many patients to unnecessary high-risk aortic surgery, or fails to identify those at risk of dissection or rupture with smaller diameters. In patients with abdominal aortic aneurysms, the investigators recently demonstrated that uptake of 18F-sodium fluoride predicts disease progression and clinical events independent of aneurysm diameter and standard clinical risk factors. Based on the investigators preliminary data, a study was proposed to look at 18F-sodium fluoride uptake in patients with bicuspid aortic valve-related aortopathy. The proposed study will shed light on the underlying pathological processes involved in aortic complications of this disease as well as potentially providing an important risk marker to predict disease progression and guide the need for major aortic surgery.

Condition or disease Intervention/treatment
Bicuspid Aortic Valve Thoracic Aortic Aneurysm Aortic Dissection Diagnostic Test: clinical evaluation, blood markers, pulse wave analysis, 18F sodium fluoride PET/CT and PET/MRI Diagnostic Test: Repeat 18F sodium fluoride PET/MRI

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-invasive Detection of Bicuspid Aortic Valve-Related Thoracic Aortopathy
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : August 3, 2021
Estimated Study Completion Date : August 3, 2021


Group/Cohort Intervention/treatment
Bicuspid aortic valve
80 patients with bicuspid aortic valve with or without an aortic aneurysm
Diagnostic Test: clinical evaluation, blood markers, pulse wave analysis, 18F sodium fluoride PET/CT and PET/MRI
Patients will receive a structured clinic history, examination, blood sampling, pulse wave analysis, pulse wave velocity, 18F-sodium fluoride PET/CT, 18F-sodium fluoride PET/MRI with detailed cardiac magnetic resonance imaging and magnetic resonance imaging of the aorta

Diagnostic Test: Repeat 18F sodium fluoride PET/MRI
as per first study visit but without the PET/CT

controls
20 healthy volunteer controls age and sex matched to 20 of the bicuspid aortic valve patients
Diagnostic Test: clinical evaluation, blood markers, pulse wave analysis, 18F sodium fluoride PET/CT and PET/MRI
Patients will receive a structured clinic history, examination, blood sampling, pulse wave analysis, pulse wave velocity, 18F-sodium fluoride PET/CT, 18F-sodium fluoride PET/MRI with detailed cardiac magnetic resonance imaging and magnetic resonance imaging of the aorta




Primary Outcome Measures :
  1. Aortic growth rate [ Time Frame: At 1-2 years after baseline visit ]
    Correlate baseline 18F sodium fluoride PET uptake with aortic growth rate, a marker of aortic wall remodelling, over 1-2 years


Secondary Outcome Measures :
  1. Aortic stiffness [ Time Frame: 1-2 years (at second study visit) ]
    Aortic stiffness, which is a biomechanical marker of how elastic the aortic wall is, has been associated with increased aortic event rates in patients with connective tissue disorders. We will measure aortic stiffness using a variety of metrics including distensibility, elastic modulus, stiffness index (all MRI derived) and pulse wave velocity (deprived using application tomography). The change in aortic stiffness and baseline aortic stiffness will be correlated with baseline PET

  2. Wall shear stress [ Time Frame: 1 year (at baseline visit) ]
    Wall shear stress is extrapolated from 4D MRI and is proposed to be linked with histological changes in the aortic wall as well as increased dilatation. We will compare areas of high wall shear stress to those of high PET uptake.


Biospecimen Retention:   Samples With DNA
Blood samples taken at each visit with ethical approval and consent to store for DNA


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Ages Eligible for Study:   20 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with bicuspid aortic valve and a variety of ascending aortic sizes
Criteria

Inclusion Criteria:

  • Bicuspid aortic Valve or Age-sex matched healthy volunteer

Exclusion Criteria:

  • Pregnancy
  • eGFR < 30
  • previous aortic replacement surgery
  • previous aortic valve surgery
  • contrast allergy
  • other reason unable to undergo MRI

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): NCT04083118


Contacts
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Contact: Chris Coner 0131 242 3326 ext 23326 Chris.Coner@ed.ac.uk
Contact: David E Newby, MD, PhD, DSc 0131 242 6515 ext 26515 D.E.Newby@ed.ac.uk

Locations
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United Kingdom
University of Edinburgh Recruiting
Edinburgh, United Kingdom, EH16 4SB
Contact: Lynn Mckinlay    0131 242 6515 ext 26515    lynn.mckinlay@ed.ac.uk   
Principal Investigator: Alexander J Fletcher, MD         
Sponsors and Collaborators
University of Edinburgh
Investigators
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Principal Investigator: Alexander J Fletcher, MD University of Edinburgh

Additional Information:
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Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT04083118     History of Changes
Other Study ID Numbers: 2018/0261
FS/19/15/34155 ( Other Grant/Funding Number: British Heart Foundation )
First Posted: September 10, 2019    Key Record Dates
Last Update Posted: September 10, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by University of Edinburgh:
positron emission tomography
sodium fluoride
bicuspid aortic valve
thoracic aortic aneurysm
aortopathy
Additional relevant MeSH terms:
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Listerine
Fluorides
Sodium Fluoride
Aneurysm, Dissecting
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Thoracic
Heart Valve Diseases
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Heart Diseases
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents