Periventricular White Matter Hyperintensities in Cerebral Amyloid Angiopathy and Hypertensive Arteriopathy

Cerebral Amyloid Angiopathy Clinical Trial

— PVWMH  

Official title:

Periventricular White Matter Hyperintensities in Cerebral Amyloid Angiopathy and Hypertensive Arteriopathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05486897
• Other study ID #: LOCAL/2022/DR-04
• Status: Completed
• Start date: September 5, 2022
• Est. completion date: December 15, 2023

Study information

• Verified date: January 2024
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 315
• Est. completion date: December 15, 2023
• Est. primary completion date: December 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Amyloidosis
• Cerebral Amyloid Angiopathy

Intervention

Other:
• None, pure observational study
None, pure observational study

Locations

Country	Name	City	State
France	CHU de Nîmes	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Ratios	Calcul of posterior/anterior ratios for both the PVWMH and CC-PVWMH	base line, day 0
Primary	Anterior PVWMH	Comparison of anterior PVWMH between CAA group and HA group.	Base line, Day 0
Primary	Posterior PVWMH	Comparison of posterior PVWMH between CAA group and HA group.	Base line, Day 0
Primary	Total PVWMH	Comparison of total PVWMH between CAA group and HA group.	Base line, Day 0
Primary	Posterior/anterior PVWMH ratio	Comparison of the posterior/anterior PVWMH ratio between CAA and HA groups.	Base line, Day 0
Primary	anterior CC-PVWMH	Comparison of anterior CC-PVWMH between CAA group and HA group.	Base line, Day 0
Primary	Posterior CC-PVWMH	Comparison of posterior CC-PVWMH between CAA group and HA group.	Base line, Day 0
Primary	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