NCT04952077

Brief Summary

Cerebral infarction by proximal occlusion of the anterior circulation is common with major personal and societal consequences. MRI is the gold standard for exploring stroke, especially ischemic, and a number of biomarkers on initial MRI (before reperfusion) are predictive of neurological prognosis. However, their spatiotemporal evolution in the suites of reperfusion is unclear. Close monitoring by MRI would make it possible to precisely know the tissue, vascular and microvascular evolution of the infarct area and the penumbra after reperfusion, and thus to characterize MRI biomarkers associated with efficient tissue reperfusion. The aim of the MR-Reperfusion study is to characterize new MRI biomarkers of efficient tissue reperfusion.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

June 17, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 7, 2021

Completed
1.8 years until next milestone

Study Start

First participant enrolled

April 15, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

April 13, 2023

Status Verified

April 1, 2023

Enrollment Period

1.5 years

First QC Date

June 17, 2021

Last Update Submit

April 12, 2023

Conditions

Ischemic Stroke, Acute

Outcome Measures

Primary Outcomes (1)

  • Description of MRI biomarkers (volume, location of the infarction and penumbra; collateral circulation; location, length of the thrombus; trans-cerebral, cortical venous changes) in patients with ischemic stroke successfully treated by thrombectomy

    Admission to hospital, 3 hours, 24 hours, 7 days and 3 months after thrombectomy

Secondary Outcomes (4)

  • Kinetic evolution of MRI biomarkers (volume, location of the infarction and penumbra; collateral circulation; location, length of the thrombus; trans-cerebral, cortical venous changes) and its correlation with the functional prognosis (mRS score)

    Admission to hospital, 3 hours, 24 hours, 7 days and 3 months after thrombectomy

  • Kinetic evolution of the NIHSS score and its correlation with the functional prognosis at 3 months evaluated by the mRS score.

    Admission to hospital, 3 hours, 24 hours, 7 days and 3 months after thrombectomy

  • Description of MRI biomarkers (volume, location of the infarction and penumbra; collateral circulation; location, length of the thrombus; trans-cerebral, cortical venous changes) and its correlation with the hemorrhagic transformation (SWAN sequence)

    24 hours after thrombectomy

  • Radioclinical concordance evaluated by measuring MRI biomarkers (volume, location of the infarction and penumbra; collateral circulation; location, length of the thrombus; trans-cerebral, cortical venous changes), the mRS score and the NIHSS score

    3 months after thrombectomy

Study Arms (1)

Experimental

EXPERIMENTAL
Device: MRI

Interventions

MRIDEVICE

Magnetic Resonance Imaging (MRI)

Experimental

Eligibility Criteria

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

You may qualify if:

  • To be over 18 year-old
  • Perfusion MRI assessment on admission;
  • Admission for an acute infarction of the anterior circulation with proximal occlusion (tandem, distal internal carotid, or M1 segment of the middle cerebral artery);
  • Initial mTICI = 0-1 on the initial angiography before treatment;
  • Patient in complete autonomy (mRS ≤ 2) before the onset of symptoms;
  • Mechanical thrombectomy (in combination or not with intravenous thrombolysis), within the first 6 hours of the onset of symptoms, or within 24 hours in case of clinical-radiological or radiological mismatch;
  • Success of reperfusion estimated by an mTICI = 3 at the end of the procedure;
  • Availability of MRI within 3 hours of angiographic reperfusion;
  • To be able to understand the instructions given;
  • Written consent given by the patient or a trusted person;
  • To be enrolled in a social security plan;

You may not qualify if:

  • Posterieur circulation obstruction;
  • months follow-up impossible with the completion of the MRI;
  • Subject under a measure of legal protection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU Nancy

Nancy, France

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Liang LIAO, MD

CONTACT

+33383851618l.liao@chru-nancy.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 17, 2021

First Posted

July 7, 2021

Study Start

April 15, 2023

Primary Completion

October 15, 2024

Study Completion

December 31, 2024

Last Updated

April 13, 2023

Record last verified: 2023-04

Locations

FR(1)