NCT05785598

Brief Summary

Transcranial Doppler ultrasonography with injection of contrast agent (intravenously to enhance the ultrasound signal) is a non-invasive technique that has been used for years to study intracranial vessels that constitute the polygon of Willis. However, this technique does not allow good visualization of small vessels, such as perforating arteries. Ultrasound localization microscopy (ULM) is based on the principle of localizing injected microbubbles in order to follow their movement to map the microvascular structure. The concentration of these microbubbles must remain low (in contrast to its classical use in Doppler ultrasound) in order to isolate and localize them. By using the same images as those performed in clinical routine by Doppler ultrasound and by processing the data offline, ULM would increase the resolution by a factor of 10 allowing potential observation of perforating arteries.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

March 14, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 27, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

March 30, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2024

Completed
Last Updated

April 24, 2026

Status Verified

April 1, 2026

Enrollment Period

1 year

First QC Date

March 14, 2023

Last Update Submit

April 21, 2026

Conditions

Keywords

Ischemic strokeMoya-MoyaSuper-Resolved UltrasoundUltrasonore microscopyPerforating arteries

Outcome Measures

Primary Outcomes (1)

  • To compare the number of perforating arteries detected by ULM with the number of perforating arteries detected on TOF MRI.

    density of perforating arteries that start from the middle cerebral artery. The unit of measurement will be a count of bubbles tracked by ULM in each pixel of the image.

    During the ULM analyse

Secondary Outcomes (2)

  • To compare the number of perforating arteries detected by ULM with the number of perforating arteries detected by the standard EDTC.

    During the ULM analyse

  • To compare the number of perforating arteries detected by ULM with the number of perforating arteries detected by arteriography in the detection of perforating arteries in patients with Moya Moya disease or syndrome.

    During the ULM analyse

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Two groups of patients who benefit from a standard transcranial ultrasound with injection of contrast product (Sonovue) as part of the standard care protocol. On one hand, patients with ischemic stroke, in the absence of middle cerebral artery occlusion and lacunar disease. In this group the perforating arteries are very fine and difficult to visualize by the usual techniques. On the other hand, patients with Moya-moya disease or syndrome. In these patients, there is an overdevelopment of the perforating arteries.

You may qualify if:

  • Patients with ischemic stroke hospitalized in the neurology department of the Bichat Hospital in the absence of middle cerebral artery occlusion or lacunar disease.
  • Patients followed in the neurology department of the Bichat/Lariboisière hospital with a diagnosis of Moya-Moya disease or syndrome
  • Patient who has had a TST with contrast injection as part of his follow-up
  • Patient who has had an MRI as part of his follow-up
  • Presence of a temporal window that allows ultrasound insonification of the polygon circle of Willis.
  • Age over 18 years.
  • Patient not objecting to the analysis of their data

You may not qualify if:

  • Patient not affiliated to French Social Security.
  • Patient under guardianship or curatorship.
  • Pregnant or breastfeeding patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AP-HP, Bichat Hospital

Paris, Paris, 75010, France

Location

MeSH Terms

Conditions

Ischemic StrokeMoyamoya Disease

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesCarotid Artery DiseasesCerebral Arterial DiseasesIntracranial Arterial DiseasesArterial Occlusive Diseases

Study Officials

  • Elena MESEGUER

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2023

First Posted

March 27, 2023

Study Start

March 30, 2023

Primary Completion

March 30, 2024

Study Completion

March 30, 2024

Last Updated

April 24, 2026

Record last verified: 2026-04

Locations