Cerebral Small Vessel DiseasesSHIVANCT05306834
Stopping Cognitive Decline and Dementia by Fighting Covert Cerebral Small Vessel Disease
A study testing Retinal Imaging, Blood sample and Evaluation of cardiovascular risks in people with Cerebral Small Vessel Diseases and Stroke, run by University Hospital, Bordeaux at 2 sites in France.
Trial summary
Cerebral small Vessel Disease (cSVD), characterized by an alteration of the structure and function of small penetrating brain arteries, is highly prevalent in older persons from the general population and represents a leading cause of stroke and a major contributor to cognitive decline and dementia risk. Read more about this study
- Who is it for?
- Ages 60 to 88 years
- Conditions the study is for
- Cerebral Small Vessel Diseases, Stroke, Dementia
- What is being tested?
- Retinal Imaging, Blood sample and Evaluation of cardiovascular risks
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 2 sitesFrance
- Study dates
- 10 Nov 2022to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 to 88 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For the extensive cSVD patient group
- For the extensive cSVD patient group included in the LEOPOLD trial:
- Patients aged 60 to 88 years,
- Patients included in the LEOPOLD trial and having performed their brain MRI on SIEMENS PRISMA machine
- Being affiliated or beneficiary of the French national health insurance ("sécurité sociale"),
- Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research study).
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- For the extensive cSVD patient group not included in the LEOPOLD trial:
- Patients aged 60 to 88 years,
- Patients with a cognitive complaint MMSE ≥ 20 performed in the 6 months before inclusion, associated or not with impaired cognitive tests and/or diaognosis of incipient dementia without pronounced cognitive deterioration,
- Patients with a socio-educational level ≥ 3,
- Patients with a moderate to high grade of hypersignals on an MRI OR on an CT scan performed prior inclusion (grades C and D of the modified Scheltens scale or grade 2/3 Fazekas),
- Arterial hypertension defined by a Systolic Blood Pressure (SBP) and / or Diastolic Blood Pressure (DBP) ≥ 140/90 mmHg (according to the definition of the national health authority [HAS]), treated or not, confirmed within the previous 12 months or at the latest on the day of inclusion.
- Being affiliated or beneficiary of the French national health insurance ("sécurité sociale"),
- Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research study)
- For the minimal cSVD patient group:
- Patients aged 60 to 88 years,
- Patients with a cognitive complaint (MMSE ≥ 20 performed at the SHIVA inclusion visit or in the 6 monts prior the visit) associated or not with impaired cognitive tests and/or diagnosis of incipient dementia without pronounced cognitive deterioration,
- Patients with little or no white matter hypertensities on brain MRI (grades 0 or 1 on the Fazekas scale); without lacunes or microbleeds,
- Arterial hypertension defined by a Systolic Blood Pressure (SBP) and / or Diastolic Blood Pressure (DBP) ≥ 140/90 mmHg (according to the definition of the national health authority [HAS]), treated or not, confirmed within the previous 12 months or at the latest on the day of inclusion. Blood pressure values for this inclusion criterion can be objectified by several self-measurements performed by the patient at home for 3 days in a sitting or lying position (3 measurements on sitting or lying position and 3 measurements in standing position).
- Being affiliated or beneficiary of the French national health insurance ("sécurité sociale"),
- Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research study
Who cannot join
- For Extensive cSVD patient group :
- For the extensive cSVD patient group also included in the LEOPOLD trial:
- patients with severe myopia greater than -6 dioptres
- partients with known allergy to Tropicamide (Mydriaticum®)
- patients with an extensive cataract
- patients with ptosis
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- For the extensive cSVD patient group not included in the LEOPOLD trial:
- Orthostatic hypotension defined by a decrease of 20 mmHg in SBP and / or 10 mmHg in DBP in a standing position at 3 minutes sought in the previous 3 months or on the day of inclusion,
- Very severe renal impairment (creatinine clearance less than 15 ml / min) on a blood test dating back less than one year,
- Secondary hypertension: renovascular hypertension, primary hyperaldosteronism, pheochromocytoma...
- Contraindication to MRI (presence of a ferromagnetic foreign body, in particular certain intracranial clips, certain heart valves, an intraocular foreign body, metal prosthesis, subject carrying a pacemaker, subject carrying prosthetic heart valves incompatible with MRI. ventricular shunt, claustrophobia),
- Associated severe diseases, with a life expectancy of less than 3 months,
- Physical problems likely to interfere with the feasibility of the tests (sight, hearing, etc.),
- Existence of dementia of which the etiology is distinct from Alzheimer's disease, vascular or mixed dementia
- Persons under tutorship or curatorship,
- Patients with loss of autonomy living in EHPAD (nursing home)
- patients with severe myopia greater than -6 dioptres
- participants with known allergy to Tropicamide (Mydriaticum®)
- patients with an extensive cataract
- patients with ptosis
- For the minimal cSVD patient group:
- Orthostatic hypotension defined by a decrease of 20 mmHg in SBP and / or 10 mmHg in DBP in a standing position at 3 minutes sought in the previous 3 months or on the day of inclusion,
- Very severe renal impairment (creatinine clearance less than 15 ml / min) on a blood test dating back less than one year,
- Secondary hypertension: renovascular hypertension, primary hyperaldosteronism, pheochromocytoma...
- Contraindication to MRI (presence of a ferromagnetic foreign body, in particular certain intracranial clips, certain heart valves, an intraocular foreign body, metal prosthesis, subject carrying a pacemaker, subject carrying prosthetic heart valves incompatible with MRI. ventricular shunt, claustrophobia),
- Associated severe diseases, with a life expectancy of less than 3 months,
- Physical problems likely to interfere with the feasibility of the tests (sight, hearing, etc.),
- Existence of dementia of which the etiology is distinct from Alzheimer's disease, vascular or mixed dementia
- Persons under tutorship or curatorship,
- Patients with loss of autonomy living in EHPAD (nursing home)
- Patients with severe myopia greater than -6 dioptries
- Patients with known allergy to Tropicamide (Mydriaticum®)
- Patients with an extensive cataract
- Patients with ptosis
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Bordeaux Hospital
Bordeaux, 33000
DEBETTE Stéphanie, Pr
- Recruiting
Broca Hospital
Paris, 75014
HANON Olivier, Pr
About this study
Cerebral small Vessel Disease (cSVD), characterized by an alteration of the structure and function of small penetrating brain arteries, is highly prevalent in older persons from the general population and represents a leading cause of stroke and a major contributor to cognitive decline and dementia risk. In France >4 million persons aged 60+ are estimated to have moderate to extensive covert cSVD (ccSVD), i.e. features of SVD on brain imaging without a history of clinical stroke. Better detection and management of covert cSVD would have a major impact on preventing disability and costs related to stroke, cognitive impairment and dementia. However, there are no specific mechanistic treatments for cSVD and hardly any recommendations worldwide on how to prevent and treat cSVD and related cognitive impairment. The aim of the present study, through the identification of novel cutting-edge multimodal biomarkers, is to develop innovative diagnostic and risk prediction tools for cSVD and its complications and to contribute to accelerating the discovery of novel drug targets and therapeutics strategies for cSVD.
Read the detailed description
cSVD is by far the most prevalent vascular contributor to cognitive impairment in the population. However, accurate quantitative estimates of the predictive ability of cSVD for dementia risk are lacking. Moreover, stratification of cognitive decline and dementia risk in cSVD patients according to imaging characteristics as well as evidence of coexisting neurodegenerative disease and vascular comorbidity are lacking. Hypertension is the strongest known risk factor for cSVD but there are currently no guidelines for the management of cSVD (or emerging guidelines based on weak evidence, and no specific mechanism-based treatments, leading to empirical and heterogeneous clinical practice, which in most instances consists of ignoring these lesions. This clinical blind spot represents a major "missed opportunity" for the prevention of cognitive decline and dementia.
This study aims to explore the relation of brain and retinal microvasculature image characteristics (imaging biomarkers), as well as molecular biomarkers derived from blood, with presence or absence of extensive cSVD and with cognitive and other clinical characteristics in two groups of 200 patients 60+ years of age. The first group will consist of patients with little or no white matter hyperintensities on brain MRI (no or minor MRI features of cSVD); while the second will include patients with moderate to severe white matter hyperintensities (MRI features of extensive cSVD).
This will create a unique deeply characterized resource for epidemiological and mechanistic investigations of cSVD, which can also serve as a pilot setting to test the trajectories and requirements for individualized patient care of cSVD patients.
The combination of retinal microvascular measurements using innovative multimodal imaging is entirely novel to our knowledge. In the context of the RHU SHIVA program, the same retained imaging protocol will be implemented for 400 young adults, which will provide insight into trajectories of these retinal biomarkers across the adult lifespan).
For the molecular biomarkers allow the validation of genomic, epigenomic, transcriptomic, proteomic, and metabolomic biomarkers for cSVD identified through secondary use of large existing cohort studies in the general population (3C, i-Share cohorts), in persons with memory complaints (MEMENTO cohort), and in collaboration with other cohorts with the Cohorts for Heart and Aging Research in Genomic Epidemiology (CHARGE) consortium, also as part of the RHU SHIVA program.
- Conditions
- Cerebral Small Vessel Diseases, Stroke, Dementia
- Being tested
- Retinal Imaging, Blood sample, Evaluation of cardiovascular risks, Brain imaging (MRI), Cognitive Tests
- Keywords
- Cognitive decline, Dementia, Stroke, Small vessel disease, Healthy brain aging, Brain imaging, Adaptive optics, Optical coherence tomography angiography, Prevention, Risk prediction, Genomic, Multiomics, Proteomics, Metabolomics
- Medical subject headings
- Cerebral Small Vessel Diseases, Stroke, Dementia, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retinal ImagingProcedure or surgery
Auto-Refractometry / Adaptative Optics (OA) / Swept Source Optical Coherence Tomography (SS-OCT-A) / Globe Axial length measurements / Color Retinophotography of the retina.
Blood sampleGenetic
Analyses of molecular biomarkers including
Evaluation of cardiovascular risksProcedure or surgery
Measurement of blood pressure and arterial stiffness
Brain imaging (MRI)Procedure or surgery
3DT1 / 3DFLAIR / T2GRE / DTI 15 directions (and B0MAP)
Cognitive TestsOther
Mini Mental State Examination (MMSE) / Montreal Cognitive Assessment (MoCA) / 16 items Free and Cued Recall (RL/RI 16 items) / Trail Making Test A et B (TMT A et B) / Frontal Assessment Battery (FAB) / Phonemic (letter P) and semantic (animals) verbal fluency tests / Digit Symbol Substitution Test (DSST)
Geriatric Depression Scale (GDS)Other
15 items
Instrumental Activities of Daily Living (IADL)Other
Instrumental Activities of Daily Living (IADL)
Unipodal standing testDiagnostic test
Unipodal standing test
Walking speed measurementOther
over 5 meters
| Study group | Role | What they receive |
|---|---|---|
| Minimal cSVD patient group | Active comparator | little or no white matter hyperintensities Receives: Procedure: Retinal Imaging; Genetic: Blood sample; Procedure: Evaluation of cardiovascular risks; Procedure: Brain imaging (MRI); Other: Cognitive Tests; Other: Geriatric Depression Scale (GDS); Other: Instrumental Activities of Daily Living (IADL); Diagnostic Test: Unipodal standing test; Other: Walking speed measurement |
| Extensive cSVD patient group | Active comparator | moderate to severe white matter hyperintensities Receives: Procedure: Retinal Imaging; Genetic: Blood sample; Procedure: Evaluation of cardiovascular risks; Procedure: Brain imaging (MRI); Other: Cognitive Tests; Other: Geriatric Depression Scale (GDS); Other: Instrumental Activities of Daily Living (IADL); Diagnostic Test: Unipodal standing test; Other: Walking speed measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of images and the molecular data
This comparison should help identify relevant biomarkers to characterize and categorize cSVD. We will also more broadly look at the association of retinal microvascular markers and molecular biomarkers with all available MRI-markers of cSVD (beyond the presence or absence of extensive white matter hyperintensities that defines the cases and controls).
Measured: Day 0 and Year 3
Secondary outcomes (7)
Degree of association between retinal and brain marker
Degree of association between retinal and brain marker
Measured: Day 0, Year 1 and Year 3
Degree of association between brain, microvascular and retinal marker
Data relating to cardiovascular risk factors / clinic data / the results of the cognitive tests, /the results of pan-genomic genotypes obtained by pan-genome genotyping or sequencing (and from blood samples) and other molecular markers
Measured: Day 0, Year 1, Year 2 and Year 3
Correlation between retinal micovascular biomarkers
SS-OCT-A (swept source optical coherence tomography angiography) and OA(Adaptive Optic)
Measured: Day 0, Year 1, Year 2 and Year 3
Reproducibility and time course of retinal vascular biomarkers
SS-OCT-A (swept source optical coherence tomography angiography) and OA (Adaptive Optic)
Measured: Between Day 0 and Year 1
Detecting, classifying and quantifying markers of retinal microvascular lesions
Performance image acquisition -OCT-A (swept source optical coherence tomography angiography) and OA (Adaptive Optic)
Measured: up to year 3
Comparison of the results in the Shiva study and SHIVA share study
Comparison of the association results and mean distributions observed in SHIVA with those observed in the SHIVA-Share
Measured: through study completion, an average of 3 year
Occurrence of incident stroke, dementia and death during follow-up.
Association of all imaging or molecular biomarkers with the occurrence of incident stroke, dementia and death during follow-up.
Measured: through study completion, an average of 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2022
- Study start10 Nov 2022
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier HANON, Pr, Principal investigator, Assistance Publique - Hôpitaux de ParisMarc JOLIOT, Dr, Study chair, Unité CNRS UMR5296, Groupe d'ImagerieCécile DELCOURT, Dr, Study chair, Centre INSERM U1219 Bordeaux Population Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05306834
- Sponsor's protocol ID
- CHUBX 2021/22
- Acronym
- SHIVA
- Status last verified
- Jan 2024
- First submitted
- 25 Feb 2022
- Last updated
- 26 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stopping Cognitive Decline and Dementia by Fighting Covert Cerebral Small Vessel Disease
- ClinicalTrials.gov ID
- NCT05306834
- Acronym / sponsor ID
- SHIVA / CHUBX 2021/22
- Conditions
- Cerebral Small Vessel Diseases, Stroke, Dementia
- Keywords
- Cognitive decline, Dementia, Stroke, Small vessel disease, Healthy brain aging, Brain imaging, Adaptive optics, Optical coherence tomography angiography
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 10 Nov 2022 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 1 Apr 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.
Cerebral small Vessel Disease (cSVD), characterized by an alteration of the structure and function of small penetrating brain arteries, is highly prevalent in older persons from the general population and represents a leading cause of stroke and a major contributor to cognitive decline and dementia risk. In France >4 million persons aged 60+ are estimated to have moderate to extensive covert cSVD (ccSVD), i.e. features of SVD on brain imaging without a history of clinical stroke. Better detection and management of covert cSVD would have a major impact on preventing disability and costs related to stroke, cognitive impairment and dementia. However, there are no specific mechanistic treatments for cSVD and hardly any recommendations worldwide on how to prevent and treat cSVD and related cognitive impairment. The aim of the present study, through the identification of novel cutting-edge multimodal biomarkers, is to develop innovative diagnostic and risk prediction tools for cSVD and its complications and to contribute to accelerating the discovery of novel drug targets and therapeutics strategies for cSVD.
Detailed description
cSVD is by far the most prevalent vascular contributor to cognitive impairment in the population. However, accurate quantitative estimates of the predictive ability of cSVD for dementia risk are lacking. Moreover, stratification of cognitive decline and dementia risk in cSVD patients according to imaging characteristics as well as evidence of coexisting neurodegenerative disease and vascular comorbidity are lacking. Hypertension is the strongest known risk factor for cSVD but there are currently no guidelines for the management of cSVD (or emerging guidelines based on weak evidence, and no specific mechanism-based treatments, leading to empirical and heterogeneous clinical practice, which in most instances consists of ignoring these lesions. This clinical blind spot represents a major "missed opportunity" for the prevention of cognitive decline and dementia.
This study aims to explore the relation of brain and retinal microvasculature image characteristics (imaging biomarkers), as well as molecular biomarkers derived from blood, with presence or absence of extensive cSVD and with cognitive and other clinical characteristics in two groups of 200 patients 60+ years of age. The first group will consist of patients with little or no white matter hyperintensities on brain MRI (no or minor MRI features of cSVD); while the second will include patients with moderate to severe white matter hyperintensities (MRI features of extensive cSVD).
This will create a unique deeply characterized resource for epidemiological and mechanistic investigations of cSVD, which can also serve as a pilot setting to test the trajectories and requirements for individualized patient care of cSVD patients.
The combination of retinal microvascular measurements using innovative multimodal imaging is entirely novel to our knowledge. In the context of the RHU SHIVA program, the same retained imaging protocol will be implemented for 400 young adults, which will provide insight into trajectories of these retinal biomarkers across the adult lifespan).
For the molecular biomarkers allow the validation of genomic, epigenomic, transcriptomic, proteomic, and metabolomic biomarkers for cSVD identified through secondary use of large existing cohort studies in the general population (3C, i-Share cohorts), in persons with memory complaints (MEMENTO cohort), and in collaboration with other cohorts with the Cohorts for Heart and Aging Research in Genomic Epidemiology (CHARGE) consortium, also as part of the RHU SHIVA program.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minimal cSVD patient group | Active comparator | Procedure: Retinal Imaging, Genetic: Blood sample, Procedure: Evaluation of cardiovascular risks, Procedure: Brain imaging (MRI), Other: Cognitive Tests, Other: Geriatric Depression Scale (GDS), Other: Instrumental Activities of Daily Living (IADL), Diagnostic Test: Unipodal standing test, Other: Walking speed measurementlittle or no white matter hyperintensities |
| Extensive cSVD patient group | Active comparator | Procedure: Retinal Imaging, Genetic: Blood sample, Procedure: Evaluation of cardiovascular risks, Procedure: Brain imaging (MRI), Other: Cognitive Tests, Other: Geriatric Depression Scale (GDS), Other: Instrumental Activities of Daily Living (IADL), Diagnostic Test: Unipodal standing test, Other: Walking speed measurementmoderate to severe white matter hyperintensities |
Who may qualify
- Ages
- 60 to 88 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- For the extensive cSVD patient group
- For the extensive cSVD patient group included in the LEOPOLD trial:
- For the extensive cSVD patient group not included in the LEOPOLD trial:
- Patients aged 60 to 88 years,
- Patients with a cognitive complaint (MMSE ≥ 20 performed at the SHIVA inclusion visit or in the 6 monts prior the visit) associated or not with impaired cognitive tests and/or diagnosis of incipient dementia without pronounced cognitive deterioration,
Key exclusion criteria (34 listed)
- For the extensive cSVD patient group also included in the LEOPOLD trial:
- For the extensive cSVD patient group not included in the LEOPOLD trial:
- Orthostatic hypotension defined by a decrease of 20 mmHg in SBP and / or 10 mmHg in DBP in a standing position at 3 minutes sought in the previous 3 months or on the day of inclusion,
- Very severe renal impairment (creatinine clearance less than 15 ml / min) on a blood test dating back less than one year,
- Secondary hypertension: renovascular hypertension, primary hyperaldosteronism, pheochromocytoma...
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 |
|---|---|---|
| Retinal ImagingAuto-Refractometry / Adaptative Optics (OA) / Swept Source Optical Coherence Tomography (SS-OCT-A) / Globe Axial length measurements / Color Retinophotography of the retina. | Procedure or surgery | Extensive cSVD patient group, Minimal cSVD patient group |
| Blood sampleAnalyses of molecular biomarkers including | Genetic | Extensive cSVD patient group, Minimal cSVD patient group |
| Evaluation of cardiovascular risksMeasurement of blood pressure and arterial stiffness | Procedure or surgery | Extensive cSVD patient group, Minimal cSVD patient group |
| Brain imaging (MRI)3DT1 / 3DFLAIR / T2GRE / DTI 15 directions (and B0MAP) | Procedure or surgery | Extensive cSVD patient group, Minimal cSVD patient group |
| Cognitive TestsMini Mental State Examination (MMSE) / Montreal Cognitive Assessment (MoCA) / 16 items Free and Cued Recall (RL/RI 16 items) / Trail Making Test A et B (TMT A et B) / Frontal Assessment Battery (FAB) / Phonemic (letter P) and semantic (animals) verbal fluency tests / Digit Symbol Substitution Test (DSST) | Other | Extensive cSVD patient group, Minimal cSVD patient group |
| Geriatric Depression Scale (GDS)15 items | Other | Extensive cSVD patient group, Minimal cSVD patient group |
| Instrumental Activities of Daily Living (IADL)Instrumental Activities of Daily Living (IADL) | Other | Extensive cSVD patient group, Minimal cSVD patient group |
| Unipodal standing testUnipodal standing test | Diagnostic test | Extensive cSVD patient group, Minimal cSVD patient group |
| Walking speed measurementover 5 meters | Other | Extensive cSVD patient group, Minimal cSVD patient group |
Primary outcome
Comparison of images and the molecular data
Time frame: Day 0 and Year 3
This comparison should help identify relevant biomarkers to characterize and categorize cSVD. We will also more broadly look at the association of retinal microvascular markers and molecular biomarkers with all available MRI-markers of cSVD (beyond the presence or absence of extensive white matter hyperintensities that defines the cases and controls).
7 secondary outcomes
Degree of association between retinal and brain marker
Time frame: Day 0, Year 1 and Year 3
Degree of association between brain, microvascular and retinal marker
Time frame: Day 0, Year 1, Year 2 and Year 3
Correlation between retinal micovascular biomarkers
Time frame: Day 0, Year 1, Year 2 and Year 3
Reproducibility and time course of retinal vascular biomarkers
Time frame: Between Day 0 and Year 1
Detecting, classifying and quantifying markers of retinal microvascular lesions
Time frame: up to year 3
Comparison of the results in the Shiva study and SHIVA share study
Time frame: through study completion, an average of 3 year
Occurrence of incident stroke, dementia and death during follow-up.
Time frame: through study completion, an average of 3 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2024.
- 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.
Olivier HANON, Pr principal investigator
Assistance Publique - Hôpitaux de Paris
Marc JOLIOT, Dr study chair
Unité CNRS UMR5296, Groupe d'Imagerie
Cécile DELCOURT, Dr study chair
Centre INSERM U1219 Bordeaux Population Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Retinal Imaging, Blood sample and Evaluation of cardiovascular risks in people with Cerebral Small Vessel Diseases and Stroke, run by University Hospital, Bordeaux at 2 sites 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 21 inclusion and 34 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: looking for participants now, as of the sponsor's last update on 26 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stéphanie DEBETTE, Pr (5.57.57.16.59 ext. +33, stephanie.debette@u-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of images and the molecular data (time frame: Day 0 and Year 3). 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 26 Jan 2024.