- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06888882
Dilated Perivascular Spaces in the Dentate Nucleus on MRI in Patients With Hypertensive Angiopathy or Cerebral Amyloid Angiopathy (HA-DN-DPVS)
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 Overview
Status
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Occitanie
-
Nîmes, Occitanie, France, 3029
- CHU de Nîmes
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Refusal to participate
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
CAA
Patients with cerebral amyloid angiopathy
|
|
HA
Patients with Hypertensive arteriopathy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sex
Time Frame: baseline
|
Comparaison of both populations (HA/CAA), H/F
|
baseline
|
|
Hypertension
Time Frame: baseline
|
history of hypertension (Yes/No)
|
baseline
|
|
Age
Time Frame: baseline
|
Age at time of T2-weighted imaging,
|
baseline
|
|
Time
Time Frame: baseline
|
Time between initial MRI-based CAA/HA diagnosis and 3T T2-weighted imaging, axial or coronal views of T2 imaging,
|
baseline
|
|
MRI view
Time Frame: baseline
|
T2 performed using coronal or axial imaging (axial / coronal
|
baseline
|
|
hypercholesterolemia
Time Frame: baseline
|
history of hypercholesterolemia (Yes/No)
|
baseline
|
|
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)
|
baseline
|
|
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).
|
baseline
|
|
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).
|
baseline
|
|
Diabete
Time Frame: baseline
|
history of diabetes (Yes/No)
|
baseline
|
|
Smoking
Time Frame: Baseline
|
current smoking (Yes / No)
|
Baseline
|
Collaborators and Investigators
Investigators
- Study Director: Anissa MEGZARI, Centre Hospitalier Universitaire de Nīmes
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Vascular Diseases
- Cardiovascular Diseases
- Metabolic Diseases
- Proteostasis Deficiencies
- Intracranial Arterial Diseases
- Cerebral Arterial Diseases
- Amyloidosis
- Nutritional and Metabolic Diseases
- Cerebral Amyloid Angiopathy
Other Study ID Numbers
- LOCAL/2025/DR-02
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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