Cerebral Small Vessel DiseasesSHIVA-SHARENCT05305144
Retinal, Cerebral and Vascular Precursor Markers of Cerebral Small Vessel Disease.
A study testing Vascular and ophthalmological examinations in people with Cerebral Small Vessel Diseases, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
Cognitive impairment and dementia are primarily due to a combination of vascular brain injury and neurodegenerative lesions. The vascular component is now recognized as a major contributor to the pathophysiology of dementia, with small vessel disease (SVD) being its most frequent substrate. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cerebral Small Vessel Diseases
- What is being tested?
- Vascular and ophthalmological examinations
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 1 siteFrance
- Study dates
- 7 Jun 2021to 7 Jun 2024
- 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
None listed.
Who cannot join
- participants with severe myopia greater than -6 dioptres
- participants with known allergy to Tropicamide (Mydriaticum®)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identification and Evaluation of Micro-vascular Retinal and Brain Markers to Establish Potential Early Brain Structural Alterations in Young Adults - SHIVA-Share
Cognitive impairment and dementia are primarily due to a combination of vascular brain injury and neurodegenerative lesions. The vascular component is now recognized as a major contributor to the pathophysiology of dementia, with small vessel disease (SVD) being its most frequent substrate. This study aims to collect retinal microvascular markers as well as various parameters related to blood pressure and arterial stiffness, in a young adult population. The main objective is to explore the association between these parameters and structural changes on brain MRI. Results will allow to determine the most relevant biomarkers associated with very early brain imaging markers of SVD.
Read the detailed description
Small Vessel Disease is most often covert i.e detectable only on brain images without being associated with a clinical stroke. Covert SVD (cSVD) is highly prevalent in older persons from the general population and is a powerful predictor of future cognitive decline and dementia risk. Better detection of covert cSVD, particularly at the earliest stages, would have a major impact on preventing disability and costs related to stroke, cognitive impairment and dementia. Studying the association of retinal and vascular biomarkers with MRI markers of brain structure will enable to facilitate the detection of patients at high risk of developing cSVD and its complications. This study aims to collect ophthalmological (retinal image acquisition - Part 1 of the study) and blood pressure / arterial stiffness (vascular assessment - Part 2 of the study) markers from 400 young adults from the Bordeaux bio-Share study. In Part 1, microvascular retinal biomarkers will be revealed by two complementary advanced technologies: the Swept-source optical coherence tomography angiography (SS-OCT-A) and the Adaptative Optics (AO). In Part 2, participants will benefit from an in-depth vascular assessment.
- Conditions
- Cerebral Small Vessel Diseases
- Being tested
- Vascular and ophthalmological examinations
- Keywords
- Cognitive decline, dementia, stroke, small vessel disease, brain imaging, adaptive optics, optical coherence tomography angiography, prevention, risk prediction
- Medical subject headings
- Cerebral Small Vessel Diseases, Cognitive Dysfunction, Dementia, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vascular and ophthalmological examinationsProcedure or surgery
Part. 1 - Vascular checkup examinations:
After collecting classic clinical parameters (weight, height, waist circumference), the in-depth vascular workup of each participant will include the following measurements:
- Measurement of central arterial pressure,
- Measurement of arterial stiffness,
- Continuous blood pressure measurement (beat-to-beat),
- Heart rate measurement,
- 24-hour blood pressure measurement with QKD (holter).
Part. 2 - Ophthalmological examinations:
After dilating the pupil, a series of examinations will be conducted on the participant:
- Auto-refractometry
- Measurement of the axial length of the globe
- Color retinophotography of the retina,
- Adaptive Optics Exam
- SS-OCT-A exam
| Study group | Role | What they receive |
|---|---|---|
| ophthalmological and vascular assessments | Experimental | This single-center national interventional study aims to collect ophthalmological (retinal image acquisition) and blood pressure (vascular assessment) data from 400 young adults from the Bordeaux bio-Share cohort, during two visits taking place one year apart. Receives: Procedure: Vascular and ophthalmological examinations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1 VASCULAR PARAMETERS RELATED TO BLOOD PRESSURE - Central arterial pressure by carotid tonometry (systolic, diastolic, mean)
Central arterial pressure by carotid tonometry (systolic, diastolic, mean)
Measured: within the inclusion visit (at the time of the vascular assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start7 Jun 2021
- Primary completion7 Jun 2024 (estimated)
- Study completion7 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Small Vessel DiseasesStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bordeaux
- Responsible party
- Sponsor
- Investigators
- Stéphanie DEBETTE, Pr, Principal investigator, INSERM U1219 Bordeaux Population Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05305144
- Sponsor's protocol ID
- CHUBX 2020/42
- Acronym
- SHIVA-SHARE
- Status last verified
- Oct 2023
- First submitted
- 22 Mar 2022
- Last updated
- 6 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification and Evaluation of Micro-vascular Retinal and Brain Markers to Establish Potential Early Brain Structural Alterations in Young Adults - SHIVA-Share
- ClinicalTrials.gov ID
- NCT05305144
- Acronym / sponsor ID
- SHIVA-SHARE / CHUBX 2020/42
- Conditions
- Cerebral Small Vessel Diseases
- Keywords
- Cognitive decline, dementia, stroke, small vessel disease, brain imaging, adaptive optics, optical coherence tomography angiography, prevention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 206 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- University of Bordeaux
- Study start
- 7 Jun 2021 (actual)
- Primary completion
- 7 Jun 2024 (estimated)
- Study completion
- 7 Jun 2024 (estimated)
- First posted
- 31 Mar 2022 (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.
Cognitive impairment and dementia are primarily due to a combination of vascular brain injury and neurodegenerative lesions. The vascular component is now recognized as a major contributor to the pathophysiology of dementia, with small vessel disease (SVD) being its most frequent substrate. This study aims to collect retinal microvascular markers as well as various parameters related to blood pressure and arterial stiffness, in a young adult population. The main objective is to explore the association between these parameters and structural changes on brain MRI. Results will allow to determine the most relevant biomarkers associated with very early brain imaging markers of SVD.
Detailed description
Small Vessel Disease is most often covert i.e detectable only on brain images without being associated with a clinical stroke. Covert SVD (cSVD) is highly prevalent in older persons from the general population and is a powerful predictor of future cognitive decline and dementia risk. Better detection of covert cSVD, particularly at the earliest stages, would have a major impact on preventing disability and costs related to stroke, cognitive impairment and dementia. Studying the association of retinal and vascular biomarkers with MRI markers of brain structure will enable to facilitate the detection of patients at high risk of developing cSVD and its complications. This study aims to collect ophthalmological (retinal image acquisition - Part 1 of the study) and blood pressure / arterial stiffness (vascular assessment - Part 2 of the study) markers from 400 young adults from the Bordeaux bio-Share study. In Part 1, microvascular retinal biomarkers will be revealed by two complementary advanced technologies: the Swept-source optical coherence tomography angiography (SS-OCT-A) and the Adaptative Optics (AO). In Part 2, participants will benefit from an in-depth vascular assessment.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ophthalmological and vascular assessments | Experimental | Procedure: Vascular and ophthalmological examinationsThis single-center national interventional study aims to collect ophthalmological (retinal image acquisition) and blood pressure (vascular assessment) data from 400 young adults from the Bordeaux bio-Share cohort, during two visits taking place one year apart. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- participants with severe myopia greater than -6 dioptres
- participants with known allergy to Tropicamide (Mydriaticum®)
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 |
|---|---|---|
| Vascular and ophthalmological examinationsPart. 1 - Vascular checkup examinations: After collecting classic clinical parameters (weight, height, waist circumference), the in-depth vascular workup of each participant will include the following measurements: * Measurement of central arterial pressure, * Measurement of arterial stiffness, * Continuous blood pressure measurement (beat-to-beat), * Heart rate measurement, * 24-hour blood pressure measurement with QKD (holter). Part. 2 - Ophthalmological examinations: After dilating the pupil, a series of examinations will be conducted on the participant: * Auto-refractometry * Measurement of the axial length of the globe * Color retinophotography of the retina, * Adaptive Optics Exam * SS-OCT-A exam | Procedure or surgery | ophthalmological and vascular assessments |
Primary outcome
Part 1 VASCULAR PARAMETERS RELATED TO BLOOD PRESSURE - Central arterial pressure by carotid tonometry (systolic, diastolic, mean)
Time frame: within the inclusion visit (at the time of the vascular assessment)
Central arterial pressure by carotid tonometry (systolic, diastolic, mean)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2023.
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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.
Stéphanie DEBETTE, Pr principal investigator
INSERM U1219 Bordeaux Population Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vascular and ophthalmological examinations in people with Cerebral Small Vessel Diseases, run by University Hospital, Bordeaux at 1 site in France.
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 0 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 6 Oct 2023. 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 France. 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?
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?
Part 1 VASCULAR PARAMETERS RELATED TO BLOOD PRESSURE - Central arterial pressure by carotid tonometry (systolic, diastolic, mean) (time frame: within the inclusion visit (at the time of the vascular assessment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Oct 2023.