NCT06888882

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

March 10, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 21, 2025

Completed
11 days until next milestone

Study Start

First participant enrolled

April 1, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

March 21, 2025

Status Verified

March 1, 2025

Enrollment Period

9 months

First QC Date

March 10, 2025

Last Update Submit

March 17, 2025

Conditions

Outcome Measures

Primary Outcomes (11)

  • Sex

    Comparaison of both populations (HA/CAA), H/F

    baseline

  • Hypertension

    history of hypertension (Yes/No)

    baseline

  • Age

    Age at time of T2-weighted imaging,

    baseline

  • Time

    Time between initial MRI-based CAA/HA diagnosis and 3T T2-weighted imaging, axial or coronal views of T2 imaging,

    baseline

  • MRI view

    T2 performed using coronal or axial imaging (axial / coronal

    baseline

  • hypercholesterolemia

    history of hypercholesterolemia (Yes/No)

    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)

    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).

    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).

    baseline

  • Diabete

    history of diabetes (Yes/No)

    baseline

  • Smoking

    current smoking (Yes / No)

    Baseline

Study Arms (2)

CAA

Patients with cerebral amyloid angiopathy

HA

Patients with Hypertensive arteriopathy

Eligibility Criteria

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

Patients with lobar intracerebral hemorrhage \[ICH\], subarachnoid hemorrhage or cortical superficial siderosis for CAA or basal ganglion ICH for HA

You may qualify if:

  • 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

You may not qualify if:

  • Refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nîmes

Nîmes, Occitanie, 3029, France

Location

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

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

March 10, 2025

First Posted

March 21, 2025

Study Start

April 1, 2025

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

March 21, 2025

Record last verified: 2025-03

Locations