NCT06809062

Brief Summary

Ischaemic microangiopathic features have recently been incorporated into the criteria for cerebral amyloid angiopathy (CAA). ApoE genotyping (presence of the E4 allele) is routinely used to help determine the aetiology of a haemorrhagic microangiopathy found on MRI. Chronic ischaemic disease in CAA is characterised by the presence of :

  • multispot pattern on the FLAIR sequence
  • severe periventricular FLAIR hypersignals with posterior predominance The main aim of this study was therefore to analyse the frequency of the presence of one (or two) E4 allele(s) on ApoE genotyping in patients with suspected CAA based on ischaemic MRI involvement with a typical radiological pattern.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2025

Shorter than P25 for all trials

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

January 24, 2025

Completed
8 days until next milestone

Study Start

First participant enrolled

February 1, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 5, 2025

Completed
11 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

February 5, 2025

Status Verified

January 1, 2025

Enrollment Period

11 months

First QC Date

January 24, 2025

Last Update Submit

January 30, 2025

Conditions

Keywords

Cerebral Amyloid Angiopathy

Outcome Measures

Primary Outcomes (1)

  • ApoE genotypage

    To analyse the frequency of the presence of one (or two) E4 allele(s) on ApoE genotyping in patients with suspected AAC. Endpoint: presence of the E4 allele (Yes/No).

    baseline

Study Arms (1)

ischaemic microangiopathy

The study is aimed at patients with manifestations related to a vascular accident visible on MRI.

Eligibility Criteria

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

Patients with ischaemic stroke (from causes other than CAA, as CAA is not a frequent cause of ischaemic stroke) with associated stigmata of microangiopathy on MRI that may suggest associated CAA.

You may qualify if:

  • Patients with ischaemic stroke (from causes other than CAA, as CAA is not a frequent cause of ischaemic stroke) with associated stigmata of microangiopathy on MRI that may suggest associated CAA.
  • Patients treated at Nîmes University Hospital

You may not qualify if:

  • Patient refusing to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Amyloid angiopathyCerebral 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

January 24, 2025

First Posted

February 5, 2025

Study Start

February 1, 2025

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

February 5, 2025

Record last verified: 2025-01