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Completed

NCT Number: NCT04073875

18F-GP1 PET-CT to Detect Bioprosthetic Aortic Valve Thrombosis

18F-GP1 binds with high affinity to the glycoprotein IIb/IIIa receptors on activated platelets. 18F-GP1 PET-CT has recently demonstrated favourable safety, pharmacokinetic, biodistribution and diagnostic performance for the in vivo identification of venous and arterial thrombemboli.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Edinburgh

Edinburgh, United Kingdom

About this study

Aortic stenosis is the most common reason for valvular interventions in the developed world, with rates projected to increase as the population ages. Aortic valve replacement remains the only recognised treatment available. Bioprostheses are far more common than mechanical prostheses, particularly with increasing rates of transcatheter heart valve use.

Bioprothetic valves are less durable than mechanical valves and are subject to deterioration which may lead to clinical heart failure and the need for re-intervention. Long-term results with surgical bioprostheses are well reported, with valve deterioration rates of less than 15% at 10 years. These data, however, rely on re-operation rather than echocardiographic measures, suggesting that the true incidence of structural valve deterioration is underestimated.

Valve thrombosis is increasingly recognised as a potential contributor to leaflet degeneration and has been detected in participants undergoing both surgical aortic valve replacement and transcatheter aortic valve implantation. The role of valve thrombosis as an early trigger for calcification and subsequent valve degeneration has not been addressed. The true incidence of valve thrombosis and its impact on clinical outcomes is unknown due to the lack of a sufficiently sensitive non-invasive imaging modality to detect early subclinical thrombosis. Current observational data suggests rates of 12 to 40%, based on computed tomography findings. There is a clinical need for a more sensitive non-invasive method of detecting valve thrombosis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ability to give informed consent
  • >1 month post-surgical or transcatheter aortic valve replacement

Exclusion criteria

  • Inability to give informed consent
  • Pregnancy or breastfeeding
  • Contraindications to iodinated contrast
  • Contraindications to anticoagulation
  • Use of anticoagulants during the post-operative period prior to screening
  • Extreme claustrophobia
  • Chronic kidney disease (with estimated glomerular filtration rate <30 mL/min/1.73m2)
  • Metastatic malignancy
  • Inability to tolerate the supine position

Treatment and study plan

18F-GP1

Diagnostic Test

18F-GP1 PET-CT scan

Primary outcomes

  1. Prevalence of 18F-GP1 PET-CT bioprosthetic aortic valve uptake

    Time frame: 2 years

    Prevalence of 18F-GP1 PET-CT bioprosthetic aortic valve uptake as measured by standardised uptake values.

  2. Intensity of 18F-GP1 PET-CT activity in bioprosthetic aortic valve thrombus

    Time frame: 2 years

    Intensity of 18F-GP1 PET-CT activity in bioprosthetic aortic valve thrombus compared to blood pool as measured by standardised uptake values.

Secondary outcomes

  1. 18F-GP1 PET-CT bioprosthetic aortic valve uptake in patients with thrombus.

    Time frame: 2 years

    18F-GP1 PET-CT bioprosthetic aortic valve uptake after 3 months in patients with evidence of thrombus at baseline as measured by standardised uptake values.

Sponsors and collaborators

Lead sponsor

University of Edinburgh

Other

Collaborators

  • British Heart Foundation
  • Lantheus Biosciences Ltd.

Registry information

Official study title

18F-GP1 Positron Emission Tomography-computed Tomography to Detect Bioprosthetic Aortic Valve Thrombosis; the Biothrombus Study.

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Aug 29, 2019
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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