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Thrombosis CardiacNCT04073875

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

An observational study of Thrombosis Cardiac and Aortic Valve Disease, run by University of Edinburgh at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Thrombosis Cardiac, Aortic Valve Disease
What is being tested?
18F-GP1
How many people
53 participants
Where
1 siteUnited Kingdom
Study dates
22 Oct 2019to 13 Oct 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients >1 month post-bioprosthetic aortic valve replacement.

Who may be able to join

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

Who cannot join

  • 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
Show all 9Show fewer
  • Chronic kidney disease (with estimated glomerular filtration rate <30 mL/min/1.73m2)
  • Metastatic malignancy
  • Inability to tolerate the supine position

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • University of Edinburgh

    Edinburgh

Other trials in United Kingdom

About this study

Official title: 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.

Read the 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.

Being tested
18F-GP1
Medical subject headings
Aortic Valve Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 18F-GP1Diagnostic test

    18F-GP1 PET-CT scan

Study groups in NCT04073875
Study groupRoleWhat they receive
Bioprosthetic aortic valveSingle 18F-GP1 PET-CT
Receives: Diagnostic Test: 18F-GP1
Bioprosthetic aortic valve thrombus - repeat imaging18F-GP1 PET-CT at baseline and 3 months
Receives: Diagnostic Test: 18F-GP1

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: 2 years

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

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

    Measured: 2 years

Secondary outcomes (1)

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

    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.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Aug 2019
  2. Study start22 Oct 2019
  3. Primary completion13 Oct 2021
  4. Study completion13 Oct 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
53 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04073875
Sponsor's protocol ID
E181981
Status last verified
Sep 2024
First submitted
22 Aug 2019
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lohrke J, Siebeneicher H, Berger M, Reinhardt M, Berndt M, Mueller A, Zerna M, Koglin N, Oden F, Bauser M, Friebe M, Dinkelborg LM, Huetter J, Stephens AW. 18F-GP1, a Novel PET Tracer Designed for High-Sensitivity, Low-Background Detection of Thrombi. J Nucl Med. 2017 Jul;58(7):1094-1099. doi: 10.2967/jnumed.116.188896. Epub 2017 Mar 16.

    PubMed 28302764

  • Kim C, Lee JS, Han Y, Chae SY, Jin S, Sung C, Son HJ, Oh SJ, Lee SJ, Oh JS, Cho YP, Kwon TW, Lee DH, Jang S, Kim B, Koglin N, Berndt M, Stephens AW, Moon DH. Glycoprotein IIb/IIIa receptor imaging with 18F-GP1 positron emission tomography for acute venous thromboembolism: an open-label, non-randomized, first-in-human phase 1 study. J Nucl Med. 2018 Jun 29;60(2):244-9. doi: 10.2967/jnumed.118.212084. Online ahead of print.

    PubMed 29959214

  • Chae SY, Kwon TW, Jin S, Kwon SU, Sung C, Oh SJ, Lee SJ, Oh JS, Han Y, Cho YP, Lee N, Kim JY, Koglin N, Berndt M, Stephens AW, Moon DH. A phase 1, first-in-human study of 18F-GP1 positron emission tomography for imaging acute arterial thrombosis. EJNMMI Res. 2019 Jan 7;9(1):3. doi: 10.1186/s13550-018-0471-8.

    PubMed 30617563

  • Lee N, Oh I, Chae SY, Jin S, Oh SJ, Lee SJ, Koglin N, Berndt M, Stephens AW, Oh JS, Moon DH. Radiation dosimetry of [18F]GP1 for imaging activated glycoprotein IIb/IIIa receptors with positron emission tomography in patients with acute thromboembolism. Nucl Med Biol. 2019 May-Jun;72-73:45-48. doi: 10.1016/j.nucmedbio.2019.07.003. Epub 2019 Jul 10.

    PubMed 31330411

  • Durko AP, Osnabrugge RL, Van Mieghem NM, Milojevic M, Mylotte D, Nkomo VT, Pieter Kappetein A. Annual number of candidates for transcatheter aortic valve implantation per country: current estimates and future projections. Eur Heart J. 2018 Jul 21;39(28):2635-2642. doi: 10.1093/eurheartj/ehy107.

    PubMed 29546396

  • Johnston DR, Soltesz EG, Vakil N, Rajeswaran J, Roselli EE, Sabik JF 3rd, Smedira NG, Svensson LG, Lytle BW, Blackstone EH. Long-term durability of bioprosthetic aortic valves: implications from 12,569 implants. Ann Thorac Surg. 2015 Apr;99(4):1239-47. doi: 10.1016/j.athoracsur.2014.10.070. Epub 2015 Feb 4.

    PubMed 25662439

  • Rodriguez-Gabella T, Voisine P, Puri R, Pibarot P, Rodes-Cabau J. Aortic Bioprosthetic Valve Durability: Incidence, Mechanisms, Predictors, and Management of Surgical and Transcatheter Valve Degeneration. J Am Coll Cardiol. 2017 Aug 22;70(8):1013-1028. doi: 10.1016/j.jacc.2017.07.715.

    PubMed 28818190

  • Chakravarty T, Sondergaard L, Friedman J, De Backer O, Berman D, Kofoed KF, Jilaihawi H, Shiota T, Abramowitz Y, Jorgensen TH, Rami T, Israr S, Fontana G, de Knegt M, Fuchs A, Lyden P, Trento A, Bhatt DL, Leon MB, Makkar RR; RESOLVE; SAVORY Investigators. Subclinical leaflet thrombosis in surgical and transcatheter bioprosthetic aortic valves: an observational study. Lancet. 2017 Jun 17;389(10087):2383-2392. doi: 10.1016/S0140-6736(17)30757-2. Epub 2017 Mar 19.

    PubMed 28330690

  • Makkar RR, Fontana G, Jilaihawi H, Chakravarty T, Kofoed KF, De Backer O, Asch FM, Ruiz CE, Olsen NT, Trento A, Friedman J, Berman D, Cheng W, Kashif M, Jelnin V, Kliger CA, Guo H, Pichard AD, Weissman NJ, Kapadia S, Manasse E, Bhatt DL, Leon MB, Sondergaard L. Possible Subclinical Leaflet Thrombosis in Bioprosthetic Aortic Valves. N Engl J Med. 2015 Nov 19;373(21):2015-24. doi: 10.1056/NEJMoa1509233. Epub 2015 Oct 5.

    PubMed 26436963

  • Bing R, Deutsch MA, Sellers SL, Corral CA, Andrews JPM, van Beek EJR, Bleiziffer S, Burchert W, Clark T, Dey D, Friedrichs K, Gummert JF, Koglin N, Leipsic JA, Lindner O, MacAskill MG, Milting H, Pessotto R, Preuss R, Raftis JB, Rudolph TK, Rudolph V, Slomka P, Stephens AW, Tavares A, Tzolos E, Weir N, White AC, Williams MC, Zabel R, Dweck MR, Hugenberg V, Newby DE. 18F-GP1 Positron Emission Tomography and Bioprosthetic Aortic Valve Thrombus. JACC Cardiovasc Imaging. 2022 Jun;15(6):1107-1120. doi: 10.1016/j.jcmg.2021.11.015. Epub 2022 Jan 12.

    PubMed 35033495

Questions about this trial

What is this clinical trial studying?

An observational study of Thrombosis Cardiac and Aortic Valve Disease, run by University of Edinburgh at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevalence of 18F-GP1 PET-CT bioprosthetic aortic valve uptake (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04073875, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.

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