Hypertensive ArteriopathyHA-DN-DPVSNCT06888882
Dilated Perivascular Spaces in the Dentate Nucleus on MRI in Patients With Hypertensive Angiopathy or Cerebral Amyloid Angiopathy
An observational study of Hypertensive Arteriopathy and Cerebral Amyloid Angiopathy, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
Hypertensive arteriopathy (HA) and cerebral amyloid angiopathy (CAA) are the two most common forms of cerebral small vessel disease. On MRI, chronic small vessel disease-related abnormalities include white matter hyperintensities, dilated perivascular spaces (DPVS), lacunar infarction, and hemorrhagic features (e.g. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertensive Arteriopathy, Cerebral Amyloid Angiopathy
- How many people
- 72 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2025to 31 Dec 2025
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with lobar intracerebral hemorrhage [ICH], subarachnoid hemorrhage or cortical superficial siderosis for CAA or basal ganglion ICH for HA
Who may be able to join
- Patient registered in the CHU de Nîmes (France) stroke database with lobar intracerebral hemorrhage [ICH], subarachnoid hemorrhage or cortical superficial siderosis for CAA or basal ganglion ICH for HA
- Patient managed at the CHU de Nîmes (France) between 01/1/2015 and 31/12/2024
- Patient with T2-weighted MRI performed with a 3T magnet
Who cannot join
- Refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
Hypertensive arteriopathy (HA) and cerebral amyloid angiopathy (CAA) are the two most common forms of cerebral small vessel disease. On MRI, chronic small vessel disease-related abnormalities include white matter hyperintensities, dilated perivascular spaces (DPVS), lacunar infarction, and hemorrhagic features (e.g. cerebral microbleeds, CMB). In the cerebellum, deep CMB involving the dentate nucleus (DN) is associated with HA, whereas the presence of superficial cerebellar CMB are associated with CAA. DPVS are observed in both diseases, predominant in the subcortical white matter (especially in the centrum semiovale) in CAA whereas HA-related DPVS are predominant deep in the brain inside or nearby the basal ganglia.
To the best of our knowledge, DN-DPVS have never been studies systematically in small vessel disease. The researchers want to study DN-DPVS on T2-weighted 3T MRI in patients with HA or CAA and to compare both groups.
- Medical subject headings
- Cerebral Amyloid Angiopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CAA | Patients with cerebral amyloid angiopathy | |
| HA | Patients with Hypertensive arteriopathy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sex
Comparaison of both populations (HA/CAA), H/F
Measured: baseline
Hypertension
history of hypertension (Yes/No)
Measured: baseline
Age
Age at time of T2-weighted imaging,
Measured: baseline
Time
Time between initial MRI-based CAA/HA diagnosis and 3T T2-weighted imaging, axial or coronal views of T2 imaging,
Measured: baseline
MRI view
T2 performed using coronal or axial imaging (axial / coronal
Measured: baseline
hypercholesterolemia
history of hypercholesterolemia (Yes/No)
Measured: baseline
Hemorrhagic lesion
Hemorrhagic lesion load on T2*-weighted imaging (ICH and CMB for both CAA and HA, and subarachnoid hemorrhage/cortical superficial siderosis for CAA)
Measured: baseline
Subcortical lobar DPVS
Semi-quantitative score for evaluation of subcortical lobar DPVS (0 if DPVS are absent, 1 if 1 to 10 DPVS are visible, 2 for 11 to 20 DPVS, 3 for 21 to 40 DPVS, and 4 for >40 DPVS).
Measured: baseline
DPVS of basal ganglia
Semi-quantitative score for evaluation of DPVS of basal ganglia (0 if DPVS are absent, 1 if 1 to 10 DPVS are visible, 2 for 11 to 20 DPVS, 3 for 21 to 40 DPVS, and 4 for >40 DPVS).
Measured: baseline
Diabete
history of diabetes (Yes/No)
Measured: baseline
Smoking
current smoking (Yes / No)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start1 Apr 2025
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertensive ArteriopathyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anissa MEGZARI, Study director, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06888882
- Sponsor's protocol ID
- LOCAL/2025/DR-02
- Acronym
- HA-DN-DPVS
- Status last verified
- Mar 2026
- First submitted
- 10 Mar 2025
- Last updated
- 29 May 2026
- 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 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dilated Perivascular Spaces in the Dentate Nucleus on MRI in Patients With Hypertensive Angiopathy or Cerebral Amyloid Angiopathy
- ClinicalTrials.gov ID
- NCT06888882
- Acronym / sponsor ID
- HA-DN-DPVS / LOCAL/2025/DR-02
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 21 Mar 2025 (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.
Hypertensive arteriopathy (HA) and cerebral amyloid angiopathy (CAA) are the two most common forms of cerebral small vessel disease. On MRI, chronic small vessel disease-related abnormalities include white matter hyperintensities, dilated perivascular spaces (DPVS), lacunar infarction, and hemorrhagic features (e.g. cerebral microbleeds, CMB). In the cerebellum, deep CMB involving the dentate nucleus (DN) is associated with HA, whereas the presence of superficial cerebellar CMB are associated with CAA. DPVS are observed in both diseases, predominant in the subcortical white matter (especially in the centrum semiovale) in CAA whereas HA-related DPVS are predominant deep in the brain inside or nearby the basal ganglia.
To the best of our knowledge, DN-DPVS have never been studies systematically in small vessel disease. The researchers want to study DN-DPVS on T2-weighted 3T MRI in patients with HA or CAA and to compare both groups.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAA | – | –Patients with cerebral amyloid angiopathy |
| HA | – | –Patients with Hypertensive arteriopathy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with lobar intracerebral hemorrhage [ICH], subarachnoid hemorrhage or cortical superficial siderosis for CAA or basal ganglion ICH for HA
Key inclusion criteria (3 listed)
- Patient registered in the CHU de Nîmes (France) stroke database with lobar intracerebral hemorrhage [ICH], subarachnoid hemorrhage or cortical superficial siderosis for CAA or basal ganglion ICH for HA
- Patient managed at the CHU de Nîmes (France) between 01/1/2015 and 31/12/2024
- Patient with T2-weighted MRI performed with a 3T magnet
Key exclusion criteria (1 listed)
- Refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sex
Time frame: baseline
Comparaison of both populations (HA/CAA), H/F
Hypertension
Time frame: baseline
history of hypertension (Yes/No)
Age
Time frame: baseline
Age at time of T2-weighted imaging,
Time
Time frame: baseline
Time between initial MRI-based CAA/HA diagnosis and 3T T2-weighted imaging, axial or coronal views of T2 imaging,
MRI view
Time frame: baseline
T2 performed using coronal or axial imaging (axial / coronal
hypercholesterolemia
Time frame: baseline
history of hypercholesterolemia (Yes/No)
Hemorrhagic lesion
Time frame: baseline
Hemorrhagic lesion load on T2*-weighted imaging (ICH and CMB for both CAA and HA, and subarachnoid hemorrhage/cortical superficial siderosis for CAA)
Subcortical lobar DPVS
Time frame: baseline
Semi-quantitative score for evaluation of subcortical lobar DPVS (0 if DPVS are absent, 1 if 1 to 10 DPVS are visible, 2 for 11 to 20 DPVS, 3 for 21 to 40 DPVS, and 4 for >40 DPVS).
DPVS of basal ganglia
Time frame: baseline
Semi-quantitative score for evaluation of DPVS of basal ganglia (0 if DPVS are absent, 1 if 1 to 10 DPVS are visible, 2 for 11 to 20 DPVS, 3 for 21 to 40 DPVS, and 4 for >40 DPVS).
Diabete
Time frame: baseline
history of diabetes (Yes/No)
Smoking
Time frame: Baseline
current smoking (Yes / No)
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 29 May 2026.
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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.
Anissa MEGZARI study director
Centre Hospitalier Universitaire de Nīmes
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 Hypertensive Arteriopathy and Cerebral Amyloid Angiopathy, run by Centre Hospitalier Universitaire de Nīmes 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 3 inclusion and 1 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 29 May 2026. 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?
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?
Sex (time frame: baseline). The study lists 11 primary outcomes in all. 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 29 May 2026.