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

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ClinicalTrials.gov Identifier: NCT04073875
Recruitment Status : Not yet recruiting
First Posted : August 29, 2019
Last Update Posted : August 29, 2019
Sponsor:
Collaborators:
Life Molecular Imaging SA
British Heart Foundation
Information provided by (Responsible Party):
University of Edinburgh

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Thrombosis Cardiac Aortic Valve Disease Diagnostic Test: 18F-GP1 Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 18F-GP1 Positron Emission Tomography-computed Tomography to Detect Bioprosthetic Aortic Valve Thrombosis; the Biothrombus Study.
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Clots

Arm Intervention/treatment
Experimental: Bioprosthetic aortic valve registry
Single 18F-GP1 PET-CT
Diagnostic Test: 18F-GP1
18F-GP1 PET-CT scan

Experimental: Bioprosthetic aortic valve thrombus - anticoagulation
18F-GP1 PET-CT + 3 months of apixaban followed by repeat 18F-GP1 PET-CT
Diagnostic Test: 18F-GP1
18F-GP1 PET-CT scan

Experimental: Bioprosthetic aortic valve thrombus - no anticoagulation
18F-GP1 PET-CT followed by repeat 18F-GP1 PET-CT after 3 months
Diagnostic Test: 18F-GP1
18F-GP1 PET-CT scan




Primary Outcome Measures :
  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 Outcome Measures :
  1. 18F-GP1 PET-CT bioprosthetic aortic valve uptake after anticoagulation in patients with thrombus. [ Time Frame: 2 years ]
    18F-GP1 PET-CT bioprosthetic aortic valve uptake after 3 months of apixaban in patients with evidence of thrombus at baseline as measured by standardised uptake values.



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ability to give informed consent
  • 1-6 months 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

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): NCT04073875


Contacts
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Contact: David E Newby, MD +44 131 242 6515 d.e.newby@ed.ac.uk
Contact: Rong Bing, MBBS rong.bing@ed.ac.uk

Sponsors and Collaborators
University of Edinburgh
Life Molecular Imaging SA
British Heart Foundation
Investigators
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Principal Investigator: David E Newby, MD University of Edinburgh

Publications:

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Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT04073875     History of Changes
Other Study ID Numbers: E181981
First Posted: August 29, 2019    Key Record Dates
Last Update Posted: August 29, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases