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

October 13, 2021 updated by: University of Edinburgh

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

53

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients >1 month post-bioprosthetic aortic valve replacement.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Bioprosthetic aortic valve
Single 18F-GP1 PET-CT
Diagnostic test: 18F-GP1
18F-GP1 PET-CT scan
Bioprosthetic aortic valve thrombus - repeat imaging
18F-GP1 PET-CT at baseline and 3 months
Diagnostic test: 18F-GP1
18F-GP1 PET-CT scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 years
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.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Edinburgh

Collaborators

British Heart Foundation
Life Molecular Imaging SA

Investigators

  • Principal Investigator: David E Newby, MD, University of Edinburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 22, 2019

Primary Completion (Actual)

May 5, 2021

Study Completion (Actual)

October 13, 2021

Study Registration Dates

First Submitted

August 22, 2019

First Submitted That Met QC Criteria

August 27, 2019

First Posted (Actual)

August 29, 2019

Study Record Updates

Last Update Posted (Actual)

October 14, 2021

Last Update Submitted That Met QC Criteria

October 13, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E181981

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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