- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05486897
Periventricular White Matter Hyperintensities in Cerebral Amyloid Angiopathy and Hypertensive Arteriopathy (PVWMH)
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 Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Nîmes, France, 30029
- CHU de Nîmes
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
CAA and HA patients, managed at Nîmes University Hospital between January 2015 and March 2022.
Exclusion Criteria:
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
cerebral amyloid angiopathy
Patient with cerebral amyloid angiopathy
|
None, pure observational study
|
|
Hypertensive arteriopathy
Patients with hypertensive arteriopathy
|
None, pure observational study
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
Base line, Day 0
|
|
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.
|
Base line, Day 0
|
|
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.
|
Base line, Day 0
|
|
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.
|
Base line, Day 0
|
|
Ratios
Time Frame: base line, day 0
|
Calcul of posterior/anterior ratios for both the PVWMH and CC-PVWMH
|
base line, day 0
|
|
Anterior PVWMH
Time Frame: Base line, Day 0
|
Comparison of anterior PVWMH between CAA group and HA group.
|
Base line, Day 0
|
|
Posterior PVWMH
Time Frame: Base line, Day 0
|
Comparison of posterior PVWMH between CAA group and HA group.
|
Base line, Day 0
|
|
Total PVWMH
Time Frame: Base line, Day 0
|
Comparison of total PVWMH between CAA group and HA group.
|
Base line, Day 0
|
|
Posterior/anterior PVWMH ratio
Time Frame: Base line, Day 0
|
Comparison of the posterior/anterior PVWMH ratio between CAA and HA groups.
|
Base line, Day 0
|
|
anterior CC-PVWMH
Time Frame: Base line, Day 0
|
Comparison of anterior CC-PVWMH between CAA group and HA group.
|
Base line, Day 0
|
|
Posterior CC-PVWMH
Time Frame: Base line, Day 0
|
Comparison of posterior CC-PVWMH between CAA group and HA group.
|
Base line, Day 0
|
|
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.
|
Base line, Day 0
|
Collaborators and Investigators
Investigators
- Study Director: Anissa MEGZARI, Centre Hospitalier Universitaire de Nîmes
Publications and helpful links
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 (Estimated)
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/2022/DR-04
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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