The AoRTAS Study
Research type
Research Study
Full title
Assessment of Risk in Thoracic Aortopathy using 18F-Sodium Fluoride
IRAS ID
247776
Contact name
David Newby
Contact email
Sponsor organisation
University of Edinburgh
ISRCTN Number
ISRCTN00000000
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 7 months, 3 days
Research summary
Patients with Marfan or Loeys-Deitz syndrome (connective tissue disorders), Turner Syndrome (loss of an X chromosome) or bicuspid aortic valve (two aortic valve leaflets instead of three) are at high risk of aortic dissection (tearing of the aorta, the main blood vessel carrying blood away from the heart to the body; a serious condition which is commonly fatal.
Current management involves measuring the width of the aorta repeatedly and undertaking surgery to replace the aorta when it gets too wide. Using the width of the aorta does not perfectly predict the risk for tearing or rupture. It may miss some patients that are at high risk and require surgery as well as meaning some patients receive surgery that are not at likely to rupture or tear.
We propose using an imaging test called positron emission tomography (PET) using a type of tracer (18F-sodium fluoride) that lets us visualise areas of aortic disease when combined with an MRI or CT. The special scanners are located in the Edinburgh Imaging Facility, QMRI where the research will take place. We plan to include patients who have Marfan/Leoys-Deitz syndrome, Turner syndrome and bicuspid aortic valve (n=20) as well as 20 controls, broadly age/sex matched to the bicuspid aortic valve group. We will expand the number of participants to 40 (adding 20) in the cohort in which PET/MRI and PET/CT appears most promising. We will perform baseline history, examination, blood pressure, blood tests, PET/CT and PET/MRI scans as well as follow up at 12-24 months.
We believe the pattern and intensity of tracer uptake on PET will help us understand the mechanisms by which devastating tearing or rupture of the aorta occurs. We will look at how tracer on PET is related to aortic width and clinical events.
REC name
South East Scotland REC 02
REC reference
18/SS/0136
Date of REC Opinion
2 Nov 2018
REC opinion
Further Information Favourable Opinion