NCT04651010

Brief Summary

Our study aims to measure metabolic and functional parameters of the infarcted territory by multimodal cerebral MRI in patients diagnosed with unilateral proximal occlusion of the middle cerebral artery and treated by thrombectomy in order to correlate those parameters to clinical outcome (evaluated by modified Rankin score) at 3 months. We aim to find early radiologic predictive factors for favorable clinical outcome in this population of patients.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
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

November 25, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 3, 2020

Completed
12 months until next milestone

Study Start

First participant enrolled

November 15, 2021

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2025

Completed
Last Updated

December 16, 2024

Status Verified

December 1, 2024

Enrollment Period

3.8 years

First QC Date

November 25, 2020

Last Update Submit

December 11, 2024

Conditions

Keywords

Ischemic strokeacute middle cerebral artery occlusionmultimodal MRIthrombectomy

Outcome Measures

Primary Outcomes (1)

  • Correlation between modified Rankin score at 3 months and multimodal MRI data

    Month 3

Secondary Outcomes (3)

  • Discharge National Institute of Health Stroke Score (NIHSS)

    Month 3

  • National Institute of Health Stroke (NIHSS) score at 3 months

    Month 3

  • Change in NIHSS score at 3 months compared to post-thrombectomy

    Month 3

Study Arms (1)

Multimodal MRI

EXPERIMENTAL
Other: Multimodal MRI

Interventions

Multimodal MRI will be realized between 12 and 24 hours after thrombectomy

Multimodal MRI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged ≥ 18 years old
  • Hospitalized at the Poitiers University Hospital
  • Acute middle cerebral artery occlusion diagnosed by CT-scan or MRI
  • NIHSS score ≥ 6 at admission
  • To be treated by thrombectomy with or without fibrinolysis
  • Written information delivered to the patient or his relatives concerning the study and its benefit and risk

You may not qualify if:

  • Patients or relatives whom a loyal information about the study cannot be given
  • Patient with cognitive impairments before MRI.
  • Patients who cannot undergo MRI because of contraindications
  • Patients too deteriorated to tolerate one hour long exam

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Poitiers

Poitiers, France

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2020

First Posted

December 3, 2020

Study Start

November 15, 2021

Primary Completion

August 15, 2025

Study Completion

August 15, 2025

Last Updated

December 16, 2024

Record last verified: 2024-12

Locations