ArteriosclerosisNCT02849405
Evaluation of the Capacity of a Camera to Identify Signs of Arteriosclerosis in Retinal Arterioles
A study testing MHRC: Metabolic Hyperspectral Retinal Camera in people with Arteriosclerosis, run by Jean-Claude Tardif at 1 site in Canada.
Trial summary
Arteriosclerosis is a degenerative and dysmetabolic disease of the arterial walls. It is known to be the principal cause of coronary artery disease (CAD). Arteriosclerosis has an impact on the entire vascularization including the microvascularization. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Arteriosclerosis
- What is being tested?
- MHRC: Metabolic Hyperspectral Retinal Camera
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 21 Dec 2016to 16 Sep 2021
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects suffering from arteriosclerosis:
- myocardial infarction
- coronary angiography showing at least one coronary stenosis (more than 50%)
- and/or coronary angioplasty
- and/or coronary bypass.
- Healthy control subjects:
Show all 9Show fewer
- absence of a medical history of cardiovascular disease
- absence of medical history of cerebrovascular disease
- absence of a medical history of peripheral arterial disease
Who cannot join
- Healthy control subjects:
- myocardial infarction or angina
- known coronary stenosis
- coronary angioplasty history or coronary bypass surgery
- stroke or transient ischemic attack history
- peripheral arterial disease history
Show all 18Show fewer
- active smoking or history smoking in the past 5 years
- diabetes mellitus
- familial hypercholesterolemia
- poorly controlled hypertension (systolic blood pressure ≥150 mm Hg)
- All subjects:
- medium or high opacity of the lens (which interferes with the MHRC imaging)
- bleeding in the vitreous (which interfere with MHRC imaging)
- presence of venous occlusion, age-related macular degeneration or glaucoma
- pupillary dilation inadequate or contra-indicated
- deficient visual fixation
- refractive error outside of the range -9 to +9
- inability to obtain satisfactory images with the MHRC
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preliminary Evaluation of the Capacity of a Metabolic Hyperspectral Retinal Camera (MHRC) to Identify an Arteriosclerosis Spectral Signature in Retinal Arterioles
Arteriosclerosis is a degenerative and dysmetabolic disease of the arterial walls. It is known to be the principal cause of coronary artery disease (CAD). Arteriosclerosis has an impact on the entire vascularization including the microvascularization. The retina is a nervous tissue that is supported by microvascularization. Therefore, systemic diseases that affect the nervous or the cardiovascular system are susceptible to have manifestations in the retina. Retinal signs associated to the risks to develop CAD (qualitative appreciation; diameter and appearance of arterioles) have been suggested. A quantitative approach would strengthen the interpretation of these evaluations.
The Metabolic Hyperspectral Retinal Camera (MHRC) - the experimental instrument - has the capacity to identify and quantify a variety of biomolecules specific to the retina and the optic nerve.
The purpose of this pilot study is to determine if the MHRC has the capacity to detect a specific hyperspectral signature in the retinal arterioles of subjects suffering from arteriosclerosis.
Read the detailed description
In this pilot study, the main goal is to evaluate the capacity of the Metabolic Hyperspectral Retinal Camera (MHRC) - the experimental instrument - to identify the presence of a specific hyperspectral signature in the retinal arterioles of subjects suffering from arteriosclerosis while this signature should not be present in the retinal arterioles of control subjects considered healthy and without arteriosclerosis risk factors. The study is open, non-controlled and without randomization or placebo.
30 subjects of each group will be enrolled in the study for a total of 60 subjects. Recruitment will take place at the Montreal Heart Institute (Montreal, Quebec, Canada) and will be led by the research team of the Principal Investigator. Specific inclusion/exclusion criteria will differentiate subjects in each group. Once subjects fitting the inclusion/exclusion criteria will be identified, they will be enrolled and asked to sign the informed consent form approved by the Research Ethics and New Technology Development Committee (Montreal Heart Institute).
Following this step, an ophthalmic examination will be performed. During this examination, both eyes will be evaluated in order to detect the presence of eye pathologies (advanced cataracts, venous occlusion, age-related macular degeneration or glaucoma) that could interfere with the analysis of the MHRC optical imaging results. The ophthalmic examination consists first of a slit-lamp evaluation and secondly of an optic coherence tomography (OCT) plus a color image of the fundus (standard instruments commonly used in ophthalmology clinics) following the instillation of eye drops to dilate the pupils. The whole examination should last 45 minutes (it takes 15 to 20 minutes for the pupil to be sufficiently dilated to carry out the examinations). If the ophthalmic examination does not reveal any of the exclusion criteria, in the next minutes, the subject will be asked to undergo the baseline MHRC examination. This baseline imaging session will last a maximum of 15 minutes.
All data according to the light signal spectrum will be analyzed subsequently. Only depersonalized data, identified solely by the subject number, will be used by the investigators.
Risks associated to the subject's participation in this research project have been evaluated. Pupil dilation will be necessary to obtain quality images of the retina using conventional imaging techniques (OCT and fundus) and with the MHRC. The subject's pupils will remain dilated for 4 to 6 hours afterward, which may cause significant glare in areas where light is strong.. The MHRC is a research instrument which images the retina non-invasively and Health Canada authorization has been obtained for its use in the context of this study. The only foreseeable harm connected to its use is discomfort connected to the injection of light into the eye. The power of the monochromatic light source has been calculated to be well below the recommended exposure limits.. Very rigorous verifications were made according to the parameters fixed by the "American National Standard for safe use of laser" (ANSI 136.1) for laser radiation exposure.
Finally, all conflicts of interested are declared in the protocol and the informed consent form. Measures are in place to mitigate them in order to maintain research and data analysis integrity.
- Conditions
- Arteriosclerosis
- Being tested
- MHRC: Metabolic Hyperspectral Retinal Camera
- Medical subject headings
- Arteriosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MHRC: Metabolic Hyperspectral Retinal CameraDevice
Comparison of hyperspectral signature of retinal arterioles between subjects suffering from arteriosclerosis and healthy control subjects.
| Study group | Role | What they receive |
|---|---|---|
| Arteriosclerosis | Other | Hyperspectral camera for arteriosclerosis Diagnostic Receives: Device: MHRC: Metabolic Hyperspectral Retinal Camera |
| Healthy controls | Other | Hyperspectral camera for healthy control Diagnostic Receives: Device: MHRC: Metabolic Hyperspectral Retinal Camera |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spectral intensity measures to visible and near infrared light around retinal arterioles in 30 patients with clearly defined atherosclerosis and 30 controls.
Data will be aggregated for all arterioles identified in retinal image to produce a single outcome
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2016 (estimated)
- Study start21 Dec 2016
- Primary completion16 Sep 2021
- Study completion16 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for ArteriosclerosisStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jean-Claude Tardif
- Sponsor type
- University, hospital or other
- Collaborators
- Montreal Heart Institute, Polytechnique Montréal
- Responsible party
- Sponsor-investigator, Jean-Claude Tardif, Montreal Heart Institute
- Investigators
- Jean-Claude Tardif, MD, Principal investigator, Montreal Heart Insitute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02849405
- Sponsor's protocol ID
- ICM-ART-P
- Status last verified
- Mar 2024
- First submitted
- 14 Jul 2016
- Last updated
- 28 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Delori FC, Webb RH, Sliney DH; American National Standards Institute. Maximum permissible exposures for ocular safety (ANSI 2000), with emphasis on ophthalmic devices. J Opt Soc Am A Opt Image Sci Vis. 2007 May;24(5):1250-65. doi: 10.1364/josaa.24.001250.
PubMed 17429471Sliney D, Aron-Rosa D, DeLori F, Fankhauser F, Landry R, Mainster M, Marshall J, Rassow B, Stuck B, Trokel S, West TM, Wolffe M; International Commission on Non-Ionizing Radiation Protection. Adjustment of guidelines for exposure of the eye to optical radiation from ocular instruments: statement from a task group of the International Commission on Non-Ionizing Radiation Protection (ICNIRP). Appl Opt. 2005 Apr 10;44(11):2162-76. doi: 10.1364/ao.44.002162.
PubMed 15835362Hansson GK. Inflammation, atherosclerosis, and coronary artery disease. N Engl J Med. 2005 Apr 21;352(16):1685-95. doi: 10.1056/NEJMra043430. No abstract available.
PubMed 15843671Abramoff MD, Garvin MK, Sonka M. Retinal imaging and image analysis. IEEE Rev Biomed Eng. 2010;3:169-208. doi: 10.1109/RBME.2010.2084567.
PubMed 22275207Tabatabaee A, Asharin MR, Dehghan MH, Pourbehi MR, Nasiri-Ahmadabadi M, Assadi M. Retinal vessel abnormalities predict coronary artery diseases. Perfusion. 2013 May;28(3):232-7. doi: 10.1177/0267659112473173. Epub 2013 Jan 15.
PubMed 23322671Wong TY, Klein R, Sharrett AR, Duncan BB, Couper DJ, Tielsch JM, Klein BE, Hubbard LD. Retinal arteriolar narrowing and risk of coronary heart disease in men and women. The Atherosclerosis Risk in Communities Study. JAMA. 2002 Mar 6;287(9):1153-9. doi: 10.1001/jama.287.9.1153.
PubMed 11879113Patel SR, Flanagan JG, Shahidi AM, Sylvestre JP, Hudson C. A prototype hyperspectral system with a tunable laser source for retinal vessel imaging. Invest Ophthalmol Vis Sci. 2013 Aug 1;54(8):5163-8. doi: 10.1167/iovs.13-12124.
PubMed 23821191Shahidi AM, Patel SR, Flanagan JG, Hudson C. Regional variation in human retinal vessel oxygen saturation. Exp Eye Res. 2013 Aug;113:143-7. doi: 10.1016/j.exer.2013.06.001. Epub 2013 Jun 18.
PubMed 23791637Kang MH, Balaratnasingam C, Yu PK, Morgan WH, McAllister IL, Cringle SJ, Yu DY. Alterations to vascular endothelium in the optic nerve head in patients with vascular comorbidities. Exp Eye Res. 2013 Jun;111:50-60. doi: 10.1016/j.exer.2013.03.005. Epub 2013 Mar 19.
PubMed 23518407Koc S, Ozin B, Altin C, Altan Yaycioglu R, Aydinalp A, Muderrisoglu H. Evaluation of circulation disorder in coronary slow flow by fundus fluorescein angiography. Am J Cardiol. 2013 Jun 1;111(11):1552-6. doi: 10.1016/j.amjcard.2013.01.324. Epub 2013 Mar 25.
PubMed 23538021Sayin N, Kara N, Uzun F, Akturk IF. A quantitative evaluation of the posterior segment of the eye using spectral-domain optical coherence tomography in carotid artery stenosis: a pilot study. Ophthalmic Surg Lasers Imaging Retina. 2015 Feb;46(2):180-5. doi: 10.3928/23258160-20150213-20.
PubMed 25707042
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Evaluation of the Capacity of a Metabolic Hyperspectral Retinal Camera (MHRC) to Identify an Arteriosclerosis Spectral Signature in Retinal Arterioles
- ClinicalTrials.gov ID
- NCT02849405
- Acronym / sponsor ID
- ICM-ART-P
- Conditions
- Arteriosclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Jean-Claude TardifUniversity, hospital or other
- Collaborators
- Montreal Heart Institute, Polytechnique Montréal
- Study start
- 21 Dec 2016 (actual)
- Primary completion
- 16 Sep 2021 (actual)
- Study completion
- 16 Sep 2021 (actual)
- First posted
- 29 Jul 2016 (estimated)
- 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.
Arteriosclerosis is a degenerative and dysmetabolic disease of the arterial walls. It is known to be the principal cause of coronary artery disease (CAD). Arteriosclerosis has an impact on the entire vascularization including the microvascularization. The retina is a nervous tissue that is supported by microvascularization. Therefore, systemic diseases that affect the nervous or the cardiovascular system are susceptible to have manifestations in the retina. Retinal signs associated to the risks to develop CAD (qualitative appreciation; diameter and appearance of arterioles) have been suggested. A quantitative approach would strengthen the interpretation of these evaluations.
The Metabolic Hyperspectral Retinal Camera (MHRC) - the experimental instrument - has the capacity to identify and quantify a variety of biomolecules specific to the retina and the optic nerve.
The purpose of this pilot study is to determine if the MHRC has the capacity to detect a specific hyperspectral signature in the retinal arterioles of subjects suffering from arteriosclerosis.
Detailed description
In this pilot study, the main goal is to evaluate the capacity of the Metabolic Hyperspectral Retinal Camera (MHRC) - the experimental instrument - to identify the presence of a specific hyperspectral signature in the retinal arterioles of subjects suffering from arteriosclerosis while this signature should not be present in the retinal arterioles of control subjects considered healthy and without arteriosclerosis risk factors. The study is open, non-controlled and without randomization or placebo.
30 subjects of each group will be enrolled in the study for a total of 60 subjects. Recruitment will take place at the Montreal Heart Institute (Montreal, Quebec, Canada) and will be led by the research team of the Principal Investigator. Specific inclusion/exclusion criteria will differentiate subjects in each group. Once subjects fitting the inclusion/exclusion criteria will be identified, they will be enrolled and asked to sign the informed consent form approved by the Research Ethics and New Technology Development Committee (Montreal Heart Institute).
Following this step, an ophthalmic examination will be performed. During this examination, both eyes will be evaluated in order to detect the presence of eye pathologies (advanced cataracts, venous occlusion, age-related macular degeneration or glaucoma) that could interfere with the analysis of the MHRC optical imaging results. The ophthalmic examination consists first of a slit-lamp evaluation and secondly of an optic coherence tomography (OCT) plus a color image of the fundus (standard instruments commonly used in ophthalmology clinics) following the instillation of eye drops to dilate the pupils. The whole examination should last 45 minutes (it takes 15 to 20 minutes for the pupil to be sufficiently dilated to carry out the examinations). If the ophthalmic examination does not reveal any of the exclusion criteria, in the next minutes, the subject will be asked to undergo the baseline MHRC examination. This baseline imaging session will last a maximum of 15 minutes.
All data according to the light signal spectrum will be analyzed subsequently. Only depersonalized data, identified solely by the subject number, will be used by the investigators.
Risks associated to the subject's participation in this research project have been evaluated. Pupil dilation will be necessary to obtain quality images of the retina using conventional imaging techniques (OCT and fundus) and with the MHRC. The subject's pupils will remain dilated for 4 to 6 hours afterward, which may cause significant glare in areas where light is strong.. The MHRC is a research instrument which images the retina non-invasively and Health Canada authorization has been obtained for its use in the context of this study. The only foreseeable harm connected to its use is discomfort connected to the injection of light into the eye. The power of the monochromatic light source has been calculated to be well below the recommended exposure limits.. Very rigorous verifications were made according to the parameters fixed by the "American National Standard for safe use of laser" (ANSI 136.1) for laser radiation exposure.
Finally, all conflicts of interested are declared in the protocol and the informed consent form. Measures are in place to mitigate them in order to maintain research and data analysis integrity.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arteriosclerosis | Other | Device: MHRC: Metabolic Hyperspectral Retinal CameraHyperspectral camera for arteriosclerosis Diagnostic |
| Healthy controls | Other | Device: MHRC: Metabolic Hyperspectral Retinal CameraHyperspectral camera for healthy control Diagnostic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- myocardial infarction
- coronary angiography showing at least one coronary stenosis (more than 50%)
- and/or coronary angioplasty
- and/or coronary bypass.
- absence of a medical history of cardiovascular disease
Key exclusion criteria (18 listed)
- myocardial infarction or angina
- known coronary stenosis
- coronary angioplasty history or coronary bypass surgery
- stroke or transient ischemic attack history
- peripheral arterial disease history
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 |
|---|---|---|
| MHRC: Metabolic Hyperspectral Retinal CameraComparison of hyperspectral signature of retinal arterioles between subjects suffering from arteriosclerosis and healthy control subjects. | Device | Arteriosclerosis, Healthy controls |
Primary outcome
Spectral intensity measures to visible and near infrared light around retinal arterioles in 30 patients with clearly defined atherosclerosis and 30 controls.
Time frame: 1 Year
Data will be aggregated for all arterioles identified in retinal image to produce a single outcome
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2024.
- Background: PubMed 17429471Delori FC, Webb RH, Sliney DH; American National Standards Institute. Maximum permissible exposures for ocular safety (ANSI 2000), with emphasis on ophthalmic devices. J Opt Soc Am A Opt Image Sci Vis. 2007 May;24(5):1250-65. doi: 10.1364/josaa.24.001250.
- Background: PubMed 15835362Sliney D, Aron-Rosa D, DeLori F, Fankhauser F, Landry R, Mainster M, Marshall J, Rassow B, Stuck B, Trokel S, West TM, Wolffe M; International Commission on Non-Ionizing Radiation Protection. Adjustment of guidelines for exposure of the eye to optical radiation from ocular instruments: statement from a task group of the International Commission on Non-Ionizing Radiation Protection (ICNIRP). Appl Opt. 2005 Apr 10;44(11):2162-76. doi: 10.1364/ao.44.002162.
- Background: PubMed 15843671Hansson GK. Inflammation, atherosclerosis, and coronary artery disease. N Engl J Med. 2005 Apr 21;352(16):1685-95. doi: 10.1056/NEJMra043430. No abstract available.
- Background: PubMed 22275207Abramoff MD, Garvin MK, Sonka M. Retinal imaging and image analysis. IEEE Rev Biomed Eng. 2010;3:169-208. doi: 10.1109/RBME.2010.2084567.
- Background: PubMed 23322671Tabatabaee A, Asharin MR, Dehghan MH, Pourbehi MR, Nasiri-Ahmadabadi M, Assadi M. Retinal vessel abnormalities predict coronary artery diseases. Perfusion. 2013 May;28(3):232-7. doi: 10.1177/0267659112473173. Epub 2013 Jan 15.
- Background: PubMed 11879113Wong TY, Klein R, Sharrett AR, Duncan BB, Couper DJ, Tielsch JM, Klein BE, Hubbard LD. Retinal arteriolar narrowing and risk of coronary heart disease in men and women. The Atherosclerosis Risk in Communities Study. JAMA. 2002 Mar 6;287(9):1153-9. doi: 10.1001/jama.287.9.1153.
- Background: PubMed 23821191Patel SR, Flanagan JG, Shahidi AM, Sylvestre JP, Hudson C. A prototype hyperspectral system with a tunable laser source for retinal vessel imaging. Invest Ophthalmol Vis Sci. 2013 Aug 1;54(8):5163-8. doi: 10.1167/iovs.13-12124.
- Background: PubMed 23791637Shahidi AM, Patel SR, Flanagan JG, Hudson C. Regional variation in human retinal vessel oxygen saturation. Exp Eye Res. 2013 Aug;113:143-7. doi: 10.1016/j.exer.2013.06.001. Epub 2013 Jun 18.
- Background: PubMed 23518407Kang MH, Balaratnasingam C, Yu PK, Morgan WH, McAllister IL, Cringle SJ, Yu DY. Alterations to vascular endothelium in the optic nerve head in patients with vascular comorbidities. Exp Eye Res. 2013 Jun;111:50-60. doi: 10.1016/j.exer.2013.03.005. Epub 2013 Mar 19.
- Background: PubMed 23538021Koc S, Ozin B, Altin C, Altan Yaycioglu R, Aydinalp A, Muderrisoglu H. Evaluation of circulation disorder in coronary slow flow by fundus fluorescein angiography. Am J Cardiol. 2013 Jun 1;111(11):1552-6. doi: 10.1016/j.amjcard.2013.01.324. Epub 2013 Mar 25.
- Background: PubMed 25707042Sayin N, Kara N, Uzun F, Akturk IF. A quantitative evaluation of the posterior segment of the eye using spectral-domain optical coherence tomography in carotid artery stenosis: a pilot study. Ophthalmic Surg Lasers Imaging Retina. 2015 Feb;46(2):180-5. doi: 10.3928/23258160-20150213-20.
- Individual participant dataSharing planned: No
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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.
Jean-Claude Tardif, MD principal investigator
Montreal Heart Insitute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MHRC: Metabolic Hyperspectral Retinal Camera in people with Arteriosclerosis, run by Jean-Claude Tardif at 1 site in Canada.
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 9 inclusion and 18 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 28 Mar 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 Canada. 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?
Spectral intensity measures to visible and near infrared light around retinal arterioles in 30 patients with clearly defined atherosclerosis and 30 controls. (time frame: 1 Year). 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 NCT02849405, which also lists 11 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 28 Mar 2024.