ApoE Genotyping Analysis in Patients With Suspected Non-h... | NCT06809062

Studies
ApoE Genotyping Analysis in Patients With Suspected Non-haemorrhagic Amyloid Angiopathy

NCT06809062

Sponsor

Centre Hospitalier Universitaire de Nīmes

Status

Completed

Last Update Posted

Jun 18, 2026Actual

Enrollment

100Actual

Phase

Not provided

Conditions

Amyloid Angiopathy

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2025Actual

Primary Completion Date

Dec 31, 2025Actual

Completion Date

Dec 31, 2025Actual

First Submitted Date

Jan 24, 2025

First Submission Date that Met QC Criteria

Jan 30, 2025

First Posted Date

Feb 5, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 17, 2026

Last Update Posted Date

Jun 18, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ischaemic microangiopathy		The study is aimed at patients with manifestations related to a vascular accident visible on MRI.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Patient refusing to participate

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Anissa MEGZARI	Centre Hospitalier Universitaire de Nīmes	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU de Nîmes		Nîmes	Gard	30029	France

Condition Browse Module

MeSH Terms

ID	Term
C538248	Amyloid angiopathy
D016657	Cerebral Amyloid Angiopathy

Ancestor Terms

ID	Term
D002539	Cerebral Arterial Diseases
D020765	Intracranial Arterial Diseases
D002561	Cerebrovascular Disorders
D001927	Brain Diseases

Browse Leaves

Not provided

Browse Branches

Not provided