Cerebral Amyloid AngiopathyPVWMHNCT05486897
Periventricular White Matter Hyperintensities in Cerebral Amyloid Angiopathy and Hypertensive Arteriopathy
An observational study of Cerebral Amyloid Angiopathy and Hypertensive Arteriopathy, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
White matter hyperintensities (WMH) are one of the small vessel disease-related MRI characteristics of both cerebral amyloid angiopathy (CAA) and hypertensive arteriopathy (HA). WMH tend to show a peri-basal ganglia pattern in HA, whereas a multiple subcortical spots pattern can be observed in CAA. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Amyloid Angiopathy, Hypertensive Arteriopathy
- What is being tested?
- None, pure observational study
- How many people
- 315 participants
- Where
- 1 siteFrance
- Study dates
- 5 Sep 2022to 15 Dec 2023
- 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: CAA and HA patients, managed at Nîmes University Hospital between January 2015 and March 2022
Who may be able to join
- CAA and HA patients, managed at Nîmes University Hospital between January 2015 and March 2022.
Who cannot join
- CAA and HA patients, treated at the CHU of Nîmes between January 2015 and March 2022, not objecting to the use of their health data
Trial locations and contacts
1 site in 1 country.
About this study
White matter hyperintensities (WMH) are one of the small vessel disease-related MRI characteristics of both cerebral amyloid angiopathy (CAA) and hypertensive arteriopathy (HA). WMH tend to show a peri-basal ganglia pattern in HA, whereas a multiple subcortical spots pattern can be observed in CAA. Periventricular WMH (PVWMH) have been reported to be posterior predominant using a semiautomated segmentation method and logarithmic transformation, not used in daily clinical practice. In these studies including CAA patients, patients initially presented with haemorrhage-related symptoms. In another study analysing PVWMH and cerebral amyloid evidence in patients with mild cognitive impairment, frontal PVWMH burden was associated with high uptake on florbetapir-PET whereas parietal and occipital PVWMH burden was associated with low CSF-amyloid-beta.
The aim of this study is the descriptive comparative analysis of the distribution of PVWMH between CAA and HA patients with radiological tools available in daily practice.
- Being tested
- None, pure observational study
- 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.
None, pure observational studyOther
None, pure observational study
| Study group | Role | What they receive |
|---|---|---|
| cerebral amyloid angiopathy | Patient with cerebral amyloid angiopathy Receives: Other: None, pure observational study | |
| Hypertensive arteriopathy | Patients with hypertensive arteriopathy Receives: Other: None, pure observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distribution of PVWMH
Maximal distance between the outer PVWMH border and the border of the lateral ventricle (on the axis oriented at 90° to the border of the ventricle)
Measured: Base line, Day 0
Distribution of PVWMH - total PVWMH extent.
The sum of the PVWMH measurements around the four ventricles horns (i.e. bilateral anterior and posteriors horns) resulted in total PVWMH extent.
Measured: Base line, Day 0
Corpus callosum (CC) WMH
Distance between the border of the third ventricle and the outer border of the WMH on the rostro-caudal axis, resulting in anterior and posterior CC-PVWMH extent measurements.
Measured: Base line, Day 0
Corpus callosum (CC) WMH - total CC-PVWMH extent.
The sum of the anterior and posterior CC-PVWMH measurements resulted in the total CC-PVWMH extent.
Measured: Base line, Day 0
Ratios
Calcul of posterior/anterior ratios for both the PVWMH and CC-PVWMH
Measured: base line, day 0
Anterior PVWMH
Comparison of anterior PVWMH between CAA group and HA group.
Measured: Base line, Day 0
Posterior PVWMH
Comparison of posterior PVWMH between CAA group and HA group.
Measured: Base line, Day 0
Total PVWMH
Comparison of total PVWMH between CAA group and HA group.
Measured: Base line, Day 0
Posterior/anterior PVWMH ratio
Comparison of the posterior/anterior PVWMH ratio between CAA and HA groups.
Measured: Base line, Day 0
anterior CC-PVWMH
Comparison of anterior CC-PVWMH between CAA group and HA group.
Measured: Base line, Day 0
Posterior CC-PVWMH
Comparison of posterior CC-PVWMH between CAA group and HA group.
Measured: Base line, Day 0
Total PVWMH and posterior/anterior CC-PVWMH ratio
Comparison of total PVWMH and posterior/anterior CC-PVWMH ratio between CAA group and HA group.
Measured: Base line, Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2022
- Study start5 Sep 2022
- Primary completion15 Dec 2023
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral Amyloid AngiopathyStudies 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
- 315 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
- NCT05486897
- Sponsor's protocol ID
- LOCAL/2022/DR-04
- Acronym
- PVWMH
- Status last verified
- Jan 2024
- First submitted
- 2 Aug 2022
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Deasy L, Laurent-Chabalier S, Wacongne A, Parvu T, Mura T, Thouvenot E, Renard D. Diagnostic Accuracy of Posterior/Anterior Periventricular WMH Ratio to Differentiate CAA From Hypertensive Arteriopathy. Stroke. 2024 Aug;55(8):2086-2093. doi: 10.1161/STROKEAHA.123.046379. Epub 2024 Jun 26.
PubMed 38920025
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Periventricular White Matter Hyperintensities in Cerebral Amyloid Angiopathy and Hypertensive Arteriopathy
- ClinicalTrials.gov ID
- NCT05486897
- Acronym / sponsor ID
- PVWMH / LOCAL/2022/DR-04
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 315 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 5 Sep 2022 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 4 Aug 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.
White matter hyperintensities (WMH) are one of the small vessel disease-related MRI characteristics of both cerebral amyloid angiopathy (CAA) and hypertensive arteriopathy (HA). WMH tend to show a peri-basal ganglia pattern in HA, whereas a multiple subcortical spots pattern can be observed in CAA. Periventricular WMH (PVWMH) have been reported to be posterior predominant using a semiautomated segmentation method and logarithmic transformation, not used in daily clinical practice. In these studies including CAA patients, patients initially presented with haemorrhage-related symptoms. In another study analysing PVWMH and cerebral amyloid evidence in patients with mild cognitive impairment, frontal PVWMH burden was associated with high uptake on florbetapir-PET whereas parietal and occipital PVWMH burden was associated with low CSF-amyloid-beta.
The aim of this study is the descriptive comparative analysis of the distribution of PVWMH between CAA and HA patients with radiological tools available in daily practice.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cerebral amyloid angiopathy | – | Other: None, pure observational studyPatient with cerebral amyloid angiopathy |
| Hypertensive arteriopathy | – | Other: None, pure observational studyPatients with hypertensive arteriopathy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- CAA and HA patients, managed at Nîmes University Hospital between January 2015 and March 2022
Key inclusion criteria (1 listed)
- CAA and HA patients, managed at Nîmes University Hospital between January 2015 and March 2022.
Key exclusion criteria (1 listed)
- CAA and HA patients, treated at the CHU of Nîmes between January 2015 and March 2022, not objecting to the use of their health data
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 |
|---|---|---|
| None, pure observational studyNone, pure observational study | Other | Hypertensive arteriopathy, cerebral amyloid angiopathy |
Primary outcome
Distribution of PVWMH
Time frame: Base line, Day 0
Maximal distance between the outer PVWMH border and the border of the lateral ventricle (on the axis oriented at 90° to the border of the ventricle)
Distribution of PVWMH - total PVWMH extent.
Time frame: Base line, Day 0
The sum of the PVWMH measurements around the four ventricles horns (i.e. bilateral anterior and posteriors horns) resulted in total PVWMH extent.
Corpus callosum (CC) WMH
Time frame: Base line, Day 0
Distance between the border of the third ventricle and the outer border of the WMH on the rostro-caudal axis, resulting in anterior and posterior CC-PVWMH extent measurements.
Corpus callosum (CC) WMH - total CC-PVWMH extent.
Time frame: Base line, Day 0
The sum of the anterior and posterior CC-PVWMH measurements resulted in the total CC-PVWMH extent.
Ratios
Time frame: base line, day 0
Calcul of posterior/anterior ratios for both the PVWMH and CC-PVWMH
Anterior PVWMH
Time frame: Base line, Day 0
Comparison of anterior PVWMH between CAA group and HA group.
Posterior PVWMH
Time frame: Base line, Day 0
Comparison of posterior PVWMH between CAA group and HA group.
Total PVWMH
Time frame: Base line, Day 0
Comparison of total PVWMH between CAA group and HA group.
Posterior/anterior PVWMH ratio
Time frame: Base line, Day 0
Comparison of the posterior/anterior PVWMH ratio between CAA and HA groups.
anterior CC-PVWMH
Time frame: Base line, Day 0
Comparison of anterior CC-PVWMH between CAA group and HA group.
Posterior CC-PVWMH
Time frame: Base line, Day 0
Comparison of posterior CC-PVWMH between CAA group and HA group.
Total PVWMH and posterior/anterior CC-PVWMH ratio
Time frame: Base line, Day 0
Comparison of total PVWMH and posterior/anterior CC-PVWMH ratio between CAA group and HA group.
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 4 Dec 2025.
- Results publication: PubMed 38920025Deasy L, Laurent-Chabalier S, Wacongne A, Parvu T, Mura T, Thouvenot E, Renard D. Diagnostic Accuracy of Posterior/Anterior Periventricular WMH Ratio to Differentiate CAA From Hypertensive Arteriopathy. Stroke. 2024 Aug;55(8):2086-2093. doi: 10.1161/STROKEAHA.123.046379. Epub 2024 Jun 26.
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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 Cerebral Amyloid Angiopathy and Hypertensive Arteriopathy, 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 1 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 4 Dec 2025. 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?
Distribution of PVWMH (time frame: Base line, Day 0). The study lists 12 primary outcomes in all. 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 NCT05486897, which also lists 1 linked publication.
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 4 Dec 2025.