NCT05486897

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
315

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 2, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 4, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

September 5, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2023

Completed
Last Updated

December 4, 2025

Status Verified

January 1, 2024

Enrollment Period

1.3 years

First QC Date

August 2, 2022

Last Update Submit

November 26, 2025

Conditions

Outcome Measures

Primary Outcomes (12)

  • 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)

    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.

    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.

    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.

    Base line, Day 0

  • Ratios

    Calcul of posterior/anterior ratios for both the PVWMH and CC-PVWMH

    base line, day 0

  • Anterior PVWMH

    Comparison of anterior PVWMH between CAA group and HA group.

    Base line, Day 0

  • Posterior PVWMH

    Comparison of posterior PVWMH between CAA group and HA group.

    Base line, Day 0

  • Total PVWMH

    Comparison of total PVWMH between CAA group and HA group.

    Base line, Day 0

  • Posterior/anterior PVWMH ratio

    Comparison of the posterior/anterior PVWMH ratio between CAA and HA groups.

    Base line, Day 0

  • anterior CC-PVWMH

    Comparison of anterior CC-PVWMH between CAA group and HA group.

    Base line, Day 0

  • Posterior CC-PVWMH

    Comparison of posterior CC-PVWMH between CAA group and HA group.

    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.

    Base line, Day 0

Study Arms (2)

cerebral amyloid angiopathy

Patient with cerebral amyloid angiopathy

Other: None, pure observational study

Hypertensive arteriopathy

Patients with hypertensive arteriopathy

Other: None, pure observational study

Interventions

None, pure observational study

Hypertensive arteriopathycerebral amyloid angiopathy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

CAA and HA patients, managed at Nîmes University Hospital between January 2015 and March 2022

You may qualify if:

  • CAA and HA patients, managed at Nîmes University Hospital between January 2015 and March 2022.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nîmes

Nîmes, 30029, France

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Cerebral Amyloid Angiopathy

Condition Hierarchy (Ancestors)

Cerebral Arterial DiseasesIntracranial Arterial DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesAmyloidosisProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Anissa MEGZARI

    Centre Hospitalier Universitaire de Nīmes

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2022

First Posted

August 4, 2022

Study Start

September 5, 2022

Primary Completion

December 15, 2023

Study Completion

December 15, 2023

Last Updated

December 4, 2025

Record last verified: 2024-01

Locations