Carotid Artery StenosisNCT06398223
Ocular Perfusion in Patients With Unilateral Carotid Artery Stenosis
An observational study of Carotid Artery Stenosis, run by Medical University of Vienna at 1 site in Austria.
Trial summary
The aim of the presented study is to evaluate ocular blood flow, respectively optic nerve head blood flow in patients with carotid artery stenosis before and after carotid endarterectomy or carotid artery stenting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Artery Stenosis
- What is being tested?
- Carotid endarterectomy (CEA) and Carotid artery stenting
- Type of treatment
- Surgery or procedure
- How many people
- 45 participants
- Where
- 1 siteAustria
- Study dates
- 9 Apr 2024to 2 May 2026
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: A total of 45 patients will be included in the study: * 15 subjects with unilateral carotid artery stenosis and planned CEA * 15 subjects with unilateral carotid artery stenosis and planned carotid artery stenting * 15 healthy age- and sex-matched control subjects
Inclusion Criteria for patients with unilateral carotid artery stenosis:
- Men and Women aged ≥ 18 years
- Signed informed consent
- Normal ophthalmic findings, unless the investigator considers an abnormality to be clinically irrelevant
- Diagnosis of unilateral carotid artery stenosis and scheduled carotid endarterectomy or carotid artery stenting
Inclusion criteria for healthy age- and sex-matched control subjects:
- Men and Women aged ≥ 18 years
- Signed informed consent
- Normal ophthalmic findings, unless the investigator considers an abnormality to be clinically irrelevant
- Normal findings in the medical history, unless the investigator considers an abnormality to be clinically irrelevant
- Non-Smokers
Exclusion criteria for patients with carotid artery stenosis and healthy age- and sex-matched control subjects:
- Blood donation in the three weeks preceding the study
- Symptoms of a clinically relevant illness in the three weeks preceding the study
- Ocular inflammation or infection within the last 3 months
- History of family history of epilepsy
- Diabetes mellitus type 1 or type 2
- Pregnant or breast-feeding women
- Women of childbearing potential (neither menopausal, nor hysterectomized, nor sterilized) not using effective contraception
Trial locations and contacts
1 site in 1 country.
Gerhard Garhöfer, Assoc. Prof. Priv. Doz. MD contact
Austria1 site, 1 recruiting
- Recruiting
Department of Clincal Pharmacology, Medical University of Vienna
Vienna, 1090
Gerhard Garhöfer, Assoc. Prof. Priv. Doz. MD, +43 40400 29880, klin-pharmakologie@meduniwien.ac.at
About this study
The aim of the presented study is to evaluate ocular blood flow, respectively optic nerve head blood flow in patients with carotid artery stenosis before and after carotid endarterectomy or carotid artery stenting. Additionally, the investigators aim to compare optic nerve head blood flow in patients with CAS and healthy age- and sex-matched control subjects. Furthermore, the investigators intend to evaluate brain tissue oxygenation in patients with carotid artery stenosis before, during and after CEA and carotid artery stenting. Finally, the investigators will assess potential correlations between LSFG and NIRS results in patients with unilateral carotid artery stenosis.
Read the detailed description
Carotid artery stenosis is a condition that can lead to severe consequences such as ocular ischemia or stroke. As the ophthalmic artery branches off the carotid artery, ocular ischemic complications include amaurosis fugax, ocular ischemic syndrome or central retinal artery occlusion. Hence, early diagnosis of carotid artery stenosis and ocular perfusion impairment is of considerable importance to prevent ocular and systemic ischemic complications.
As the retina offers a unique window for examining the microcirculation in a non-invasive manner, several imaging techniques have already been used in recent years to assess ocular alterations associated with carotid artery stenosis. However, these examination techniques have their limitations and are therefore not suitable methods for determining ocular perfusion. On the contrary, Laser Speckle Flowgraphy (LSFG) is a non-invasive, in-vivo imaging method which quantitatively estimates blood flow in the optic nerve head, the choroid, the retina and the iris. LSFG offers a promising alternative from conventional methods, as it eliminates the need for contrast agents, has a low procedural complexity and obtains precise and reproducible measurements.
As the eye and brain share a close vascular relationship, both receiving blood supply from branches of the internal carotid artery, there is potential to establish a correlation between cerebral and ocular hemodynamics. Near-infrared spectroscopy (NIRS) is a simple and non-invasive method which enables continuous assessment of cerebral oxygenation. However, data on the course of oxygenation of the brain tissue using NIRS before, during and after carotid interventions are scarce. Additionally, there is a lack of comparative NIRS data between carotid endarterectomy (CEA) and carotid artery stenting. Furthermore, correlation studies between oxygenation of the brain tissue and ocular perfusion are largely missing.
Hence, the aim of this study is to evaluate optic nerve head blood flow in patients with carotid artery stenosis before and after CEA or carotid artery stenting. Additionally, the investigators will compare optic nerve head blood flow in patients with carotid artery stenosis to healthy sex- and age-matched control subjects. Furthermore, the investigators intend to evaluate brain tissue oxygenation in patients with carotid artery stenosis before, during and after CEA and carotid artery stenting. Finally, the investigators will assess potential correlations between LSFG and NIRS results in patients with unilateral carotid artery stenosis.
- Conditions
- Carotid Artery Stenosis
- Being tested
- Carotid endarterectomy (CEA), Carotid artery stenting
- Medical subject headings
- Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carotid endarterectomy (CEA)Procedure or surgery
Carotid endarterectomy (CEA): Surgical procedure to remove the plaque buildup in the carotid artery.
Carotid artery stentingProcedure or surgery
Carotid artery stenting: Treatment of the stenosis with a stent. The plaque in the artery wall is not removed but the narrowing is dilated.
| Study group | Role | What they receive |
|---|---|---|
| Carotid endarterectomy (CEA) (Group 1) | Subjects with unilateral carotid artery stenosis and planned CEA Receives: Procedure: Carotid endarterectomy (CEA) | |
| Carotid artery stenting (Group 2) | Subjects with unilateral carotid artery stenosis and planned carotid artery stenting Receives: Procedure: Carotid artery stenting | |
| Healthy Control Group (Group 3) | Healthy age- and sex-matched control subjects |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optic nerve head blood flow
Change in optic nerve head blood flow (LSFG) in patients with unilateral carotid artery stenosis before and after carotid endarterectomy or carotid artery stenting
Measured: Before and 4-6 weeks after CEA or carotid artery stenting
Secondary outcomes (1)
Retinal oxygen saturation and retinal vessel diameter
Change in retinal oxygen saturation and retinal vessel diameter (retinal oximetry)
Measured: Before and 4-6 weeks after CEA or carotid artery stenting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2024
- Study start9 Apr 2024
- Primary completion2 May 2026 (estimated)
- Study completion2 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Carotid Artery StenosisStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gerhard Garhofer, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06398223
- Sponsor's protocol ID
- OPHT-101023
- Status last verified
- May 2024
- First submitted
- 22 Apr 2024
- Last updated
- 3 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ismail A, Ravipati S, Gonzalez-Hernandez D, Mahmood H, Imran A, Munoz EJ, Naeem S, Abdin ZU, Siddiqui HF. Carotid Artery Stenosis: A Look Into the Diagnostic and Management Strategies, and Related Complications. Cureus. 2023 May 9;15(5):e38794. doi: 10.7759/cureus.38794. eCollection 2023 May.
PubMed 37303351Lahme L, Marchiori E, Panuccio G, Nelis P, Schubert F, Mihailovic N, Torsello G, Eter N, Alnawaiseh M. Changes in retinal flow density measured by optical coherence tomography angiography in patients with carotid artery stenosis after carotid endarterectomy. Sci Rep. 2018 Nov 21;8(1):17161. doi: 10.1038/s41598-018-35556-4.
PubMed 30464189Pierro L, Arrigo A, De Crescenzo M, Aragona E, Chiesa R, Castellano R, Catenaccio B, Bandello F. Quantitative Optical Coherence Tomography Angiography Detects Retinal Perfusion Changes in Carotid Artery Stenosis. Front Neurosci. 2021 Apr 22;15:640666. doi: 10.3389/fnins.2021.640666. eCollection 2021.
PubMed 33967678Woo SY, Joh JH, Han SA, Park HC. Prevalence and risk factors for atherosclerotic carotid stenosis and plaque: A population-based screening study. Medicine (Baltimore). 2017 Jan;96(4):e5999. doi: 10.1097/MD.0000000000005999.
PubMed 28121957Hackam DG. Optimal Medical Management of Asymptomatic Carotid Stenosis. Stroke. 2021 Jun;52(6):2191-2198. doi: 10.1161/STROKEAHA.120.033994. Epub 2021 May 5.
PubMed 33947208Kwapong WR, Liu J, Wan J, Tao W, Ye C, Wu B. Retinal Thickness Correlates with Cerebral Hemodynamic Changes in Patients with Carotid Artery Stenosis. Brain Sci. 2022 Jul 25;12(8):979. doi: 10.3390/brainsci12080979.
PubMed 35892420Song P, Fang Z, Wang H, Cai Y, Rahimi K, Zhu Y, Fowkes FGR, Fowkes FJI, Rudan I. Global and regional prevalence, burden, and risk factors for carotid atherosclerosis: a systematic review, meta-analysis, and modelling study. Lancet Glob Health. 2020 May;8(5):e721-e729. doi: 10.1016/S2214-109X(20)30117-0.
PubMed 32353319Cohen R, Padilla J, Light D, Diller R. Carotid artery occlusive disease and ocular manifestations: Importance of identifying patients at risk. Optometry. 2010 Jul;81(7):359-63. doi: 10.1016/j.optm.2009.10.013.
PubMed 20630374Batu Oto B, Kilicarslan O, Kayadibi Y, Yilmaz Cebi A, Adaletli I, Yildirim SR. Retinal Microvascular Changes in Internal Carotid Artery Stenosis. J Clin Med. 2023 Sep 16;12(18):6014. doi: 10.3390/jcm12186014.
PubMed 37762953Arthur A, Alexander A, Bal S, Sivadasan A, Aaron S. Ophthalmic masquerades of the atherosclerotic carotids. Indian J Ophthalmol. 2014 Apr;62(4):472-6. doi: 10.4103/0301-4738.121183.
PubMed 24817748Mursch-Edlmayr AS, Luft N, Podkowinski D, Ring M, Schmetterer L, Bolz M. Laser speckle flowgraphy derived characteristics of optic nerve head perfusion in normal tension glaucoma and healthy individuals: a Pilot study. Sci Rep. 2018 Mar 28;8(1):5343. doi: 10.1038/s41598-018-23149-0.
PubMed 29593269Luft N, Wozniak PA, Aschinger GC, Fondi K, Bata AM, Werkmeister RM, Schmidl D, Witkowska KJ, Bolz M, Garhofer G, Schmetterer L. Ocular Blood Flow Measurements in Healthy White Subjects Using Laser Speckle Flowgraphy. PLoS One. 2016 Dec 13;11(12):e0168190. doi: 10.1371/journal.pone.0168190. eCollection 2016.
PubMed 27959905Bissacco D, Attisani L, Settembrini AM, Fossati A, Carmo M, Dallatana R, Settembrini PG. Modifications in Near Infrared Spectroscopy for Cerebral Monitoring During Carotid Endarterectomy in Asymptomatic and Symptomatic Patients. Ann Vasc Surg. 2022 Feb;79:239-246. doi: 10.1016/j.avsg.2021.06.047. Epub 2021 Oct 10.
PubMed 34644636Ismail A, Chen HC, Faye I, Tang TB. Longitudinal effects of common carotid artery stenosis on ocular hemodynamics assessed using laser speckle flowgraphy in a rabbit model. Sci Rep. 2020 Sep 28;10(1):15829. doi: 10.1038/s41598-020-72556-9.
PubMed 32985560
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ocular Perfusion in Patients With Unilateral Carotid Artery Stenosis
- ClinicalTrials.gov ID
- NCT06398223
- Acronym / sponsor ID
- OPHT-101023
- Conditions
- Carotid Artery Stenosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 9 Apr 2024 (actual)
- Primary completion
- 2 May 2026 (estimated)
- Study completion
- 2 May 2026 (estimated)
- First posted
- 3 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the presented study is to evaluate ocular blood flow, respectively optic nerve head blood flow in patients with carotid artery stenosis before and after carotid endarterectomy or carotid artery stenting. Additionally, the investigators aim to compare optic nerve head blood flow in patients with CAS and healthy age- and sex-matched control subjects. Furthermore, the investigators intend to evaluate brain tissue oxygenation in patients with carotid artery stenosis before, during and after CEA and carotid artery stenting. Finally, the investigators will assess potential correlations between LSFG and NIRS results in patients with unilateral carotid artery stenosis.
Detailed description
Carotid artery stenosis is a condition that can lead to severe consequences such as ocular ischemia or stroke. As the ophthalmic artery branches off the carotid artery, ocular ischemic complications include amaurosis fugax, ocular ischemic syndrome or central retinal artery occlusion. Hence, early diagnosis of carotid artery stenosis and ocular perfusion impairment is of considerable importance to prevent ocular and systemic ischemic complications.
As the retina offers a unique window for examining the microcirculation in a non-invasive manner, several imaging techniques have already been used in recent years to assess ocular alterations associated with carotid artery stenosis. However, these examination techniques have their limitations and are therefore not suitable methods for determining ocular perfusion. On the contrary, Laser Speckle Flowgraphy (LSFG) is a non-invasive, in-vivo imaging method which quantitatively estimates blood flow in the optic nerve head, the choroid, the retina and the iris. LSFG offers a promising alternative from conventional methods, as it eliminates the need for contrast agents, has a low procedural complexity and obtains precise and reproducible measurements.
As the eye and brain share a close vascular relationship, both receiving blood supply from branches of the internal carotid artery, there is potential to establish a correlation between cerebral and ocular hemodynamics. Near-infrared spectroscopy (NIRS) is a simple and non-invasive method which enables continuous assessment of cerebral oxygenation. However, data on the course of oxygenation of the brain tissue using NIRS before, during and after carotid interventions are scarce. Additionally, there is a lack of comparative NIRS data between carotid endarterectomy (CEA) and carotid artery stenting. Furthermore, correlation studies between oxygenation of the brain tissue and ocular perfusion are largely missing.
Hence, the aim of this study is to evaluate optic nerve head blood flow in patients with carotid artery stenosis before and after CEA or carotid artery stenting. Additionally, the investigators will compare optic nerve head blood flow in patients with carotid artery stenosis to healthy sex- and age-matched control subjects. Furthermore, the investigators intend to evaluate brain tissue oxygenation in patients with carotid artery stenosis before, during and after CEA and carotid artery stenting. Finally, the investigators will assess potential correlations between LSFG and NIRS results in patients with unilateral carotid artery stenosis.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Carotid endarterectomy (CEA) (Group 1) | – | Procedure: Carotid endarterectomy (CEA)Subjects with unilateral carotid artery stenosis and planned CEA |
| Carotid artery stenting (Group 2) | – | Procedure: Carotid artery stentingSubjects with unilateral carotid artery stenosis and planned carotid artery stenting |
| Healthy Control Group (Group 3) | – | –Healthy age- and sex-matched control subjects |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- A total of 45 patients will be included in the study: * 15 subjects with unilateral carotid artery stenosis and planned CEA * 15 subjects with unilateral carotid artery stenosis and planned carotid artery stenting * 15 healthy age- and sex-matched control subjects
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carotid endarterectomy (CEA)Carotid endarterectomy (CEA): Surgical procedure to remove the plaque buildup in the carotid artery. | Procedure or surgery | Carotid endarterectomy (CEA) (Group 1) |
| Carotid artery stentingCarotid artery stenting: Treatment of the stenosis with a stent. The plaque in the artery wall is not removed but the narrowing is dilated. | Procedure or surgery | Carotid artery stenting (Group 2) |
Primary outcome
Optic nerve head blood flow
Time frame: Before and 4-6 weeks after CEA or carotid artery stenting
Change in optic nerve head blood flow (LSFG) in patients with unilateral carotid artery stenosis before and after carotid endarterectomy or carotid artery stenting
1 secondary outcome
Retinal oxygen saturation and retinal vessel diameter
Time frame: Before and 4-6 weeks after CEA or carotid artery stenting
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
- Background: PubMed 37303351Ismail A, Ravipati S, Gonzalez-Hernandez D, Mahmood H, Imran A, Munoz EJ, Naeem S, Abdin ZU, Siddiqui HF. Carotid Artery Stenosis: A Look Into the Diagnostic and Management Strategies, and Related Complications. Cureus. 2023 May 9;15(5):e38794. doi: 10.7759/cureus.38794. eCollection 2023 May.
- Background: PubMed 30464189Lahme L, Marchiori E, Panuccio G, Nelis P, Schubert F, Mihailovic N, Torsello G, Eter N, Alnawaiseh M. Changes in retinal flow density measured by optical coherence tomography angiography in patients with carotid artery stenosis after carotid endarterectomy. Sci Rep. 2018 Nov 21;8(1):17161. doi: 10.1038/s41598-018-35556-4.
- Background: PubMed 33967678Pierro L, Arrigo A, De Crescenzo M, Aragona E, Chiesa R, Castellano R, Catenaccio B, Bandello F. Quantitative Optical Coherence Tomography Angiography Detects Retinal Perfusion Changes in Carotid Artery Stenosis. Front Neurosci. 2021 Apr 22;15:640666. doi: 10.3389/fnins.2021.640666. eCollection 2021.
- Background: PubMed 28121957Woo SY, Joh JH, Han SA, Park HC. Prevalence and risk factors for atherosclerotic carotid stenosis and plaque: A population-based screening study. Medicine (Baltimore). 2017 Jan;96(4):e5999. doi: 10.1097/MD.0000000000005999.
- Background: PubMed 33947208Hackam DG. Optimal Medical Management of Asymptomatic Carotid Stenosis. Stroke. 2021 Jun;52(6):2191-2198. doi: 10.1161/STROKEAHA.120.033994. Epub 2021 May 5.
- Background: PubMed 35892420Kwapong WR, Liu J, Wan J, Tao W, Ye C, Wu B. Retinal Thickness Correlates with Cerebral Hemodynamic Changes in Patients with Carotid Artery Stenosis. Brain Sci. 2022 Jul 25;12(8):979. doi: 10.3390/brainsci12080979.
- Background: PubMed 32353319Song P, Fang Z, Wang H, Cai Y, Rahimi K, Zhu Y, Fowkes FGR, Fowkes FJI, Rudan I. Global and regional prevalence, burden, and risk factors for carotid atherosclerosis: a systematic review, meta-analysis, and modelling study. Lancet Glob Health. 2020 May;8(5):e721-e729. doi: 10.1016/S2214-109X(20)30117-0.
- Background: PubMed 20630374Cohen R, Padilla J, Light D, Diller R. Carotid artery occlusive disease and ocular manifestations: Importance of identifying patients at risk. Optometry. 2010 Jul;81(7):359-63. doi: 10.1016/j.optm.2009.10.013.
- Background: PubMed 37762953Batu Oto B, Kilicarslan O, Kayadibi Y, Yilmaz Cebi A, Adaletli I, Yildirim SR. Retinal Microvascular Changes in Internal Carotid Artery Stenosis. J Clin Med. 2023 Sep 16;12(18):6014. doi: 10.3390/jcm12186014.
- Background: PubMed 24817748Arthur A, Alexander A, Bal S, Sivadasan A, Aaron S. Ophthalmic masquerades of the atherosclerotic carotids. Indian J Ophthalmol. 2014 Apr;62(4):472-6. doi: 10.4103/0301-4738.121183.
- Background: PubMed 29593269Mursch-Edlmayr AS, Luft N, Podkowinski D, Ring M, Schmetterer L, Bolz M. Laser speckle flowgraphy derived characteristics of optic nerve head perfusion in normal tension glaucoma and healthy individuals: a Pilot study. Sci Rep. 2018 Mar 28;8(1):5343. doi: 10.1038/s41598-018-23149-0.
- Background: PubMed 27959905Luft N, Wozniak PA, Aschinger GC, Fondi K, Bata AM, Werkmeister RM, Schmidl D, Witkowska KJ, Bolz M, Garhofer G, Schmetterer L. Ocular Blood Flow Measurements in Healthy White Subjects Using Laser Speckle Flowgraphy. PLoS One. 2016 Dec 13;11(12):e0168190. doi: 10.1371/journal.pone.0168190. eCollection 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerhard Garhöfer, Assoc. Prof. Priv. Doz. MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carotid Artery Stenosis, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 3 May 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 Austria. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gerhard Garhöfer, Assoc. Prof. Priv. Doz. MD (+43 1 40400 29880, klin-pharmakologie@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optic nerve head blood flow (time frame: Before and 4-6 weeks after CEA or carotid artery stenting). 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 NCT06398223, which also lists 14 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 3 May 2024.