BioThrombus
Research type
Research Study
Full title
In vivo imaging of GPIIb/IIIa receptor activity in aortic valve bioprostheses with 18F-GP1.
IRAS ID
251790
Contact name
David Newby
Contact email
Sponsor organisation
University of Edinburgh
Duration of Study in the UK
2 years, 0 months, 4 days
Research summary
We aim to use 18F-GP1, a novel radiotracer, and combined positron emission tomography and computed tomography (a type of hybrid nuclear medicine and x-ray imaging), to detect the activity of platelets, a type of blood cell, in blood clots on bioprosthetic (tissue) aortic valve replacements. We will randomly allocate patients who have platelet activity to either apixaban, a routine blood-thinning medication, or standard care. We will then repeat an 18F-GP1 PET-CT scan to see if there is there is any change in platelet activity.
Aortic valve replacement is the most common heart valve replacement operation and rates are rising due to technical advances in valve types and deployment systems. The most common type of artificial valve is made of tissue rather than metal. This type of valve does not usually require long-term blood-thinning medication, but they are less durable and have significant rates of failure after 10 years, after which adverse outcomes increase and repeat surgery may be required. Maximising durability of these valves is therefore of major importance. There is increasing evidence that thrombus (blood clots) forming on the valve are relatively common, and that this may be a trigger for hardening and degeneration of the valve. Currently there are only indirect means to detect thrombus early before the onset of valve degeneration.
18F-GP1 has undergone animal and human validation, demonstrating avid binding to platelets (a key component of thrombus) and a favourable safety profile. If successful, this would be the first trial utilising a dedicated radiotracer to directly assess platelet activity in valve thrombus and show the effect of blood-thinning medication on platelet activity and thrombus resolution.
REC name
South East Scotland REC 01
REC reference
18/SS/0163
Date of REC Opinion
10 Dec 2018
REC opinion
Favourable Opinion