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MRI Biomarkers of Effective Tissue Reperfusion After Thrombectomy of an Acute Proximal Occlusion of the Anterior Circulation (MR-Reperfusion)

Primary Purpose

Ischemic Stroke, Acute

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

MRI

About this trial

This is an interventional diagnostic trial for Ischemic Stroke, Acute

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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;

Exclusion Criteria:

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

Sites / Locations

CHRU NancyRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)

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

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)

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

Full Information

NCT ID

NCT04952077

First Posted

June 17, 2021

Last Updated

April 12, 2023

Sponsor

Central Hospital, Nancy, France

1. Study Identification

Unique Protocol Identification Number

NCT04952077

Brief Title

MRI Biomarkers of Effective Tissue Reperfusion After Thrombectomy of an Acute Proximal Occlusion of the Anterior Circulation

Acronym

MR-Reperfusion

Official Title

MRI Biomarkers of Effective Tissue Reperfusion After Thrombectomy of an Acute Proximal Occlusion of the Anterior Circulation: MR-Reperfusion Longitudinal Study

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 15, 2023 (Anticipated)

Primary Completion Date

October 15, 2024 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Central Hospital, Nancy, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ischemic Stroke, Acute

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

MRI

Intervention Description

Magnetic Resonance Imaging (MRI)

Primary Outcome Measure Information:

Title

Time Frame

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

Secondary Outcome Measure Information:

Title

Time Frame

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

Title

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

Time Frame

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

Title

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)

Time Frame

24 hours after thrombectomy

Title

Time Frame

3 months after thrombectomy

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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; Exclusion Criteria: Posterieur circulation obstruction; 3 months follow-up impossible with the completion of the MRI; Subject under a measure of legal protection

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Liang LIAO, MD

Phone

+33383851618

l.liao@chru-nancy.fr

Facility Information:

Facility Name

CHRU Nancy

City

Nancy

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Liang LIAO, MD

l.liao@chru-nancy.fr

12. IPD Sharing Statement

Learn more about this trial

MRI Biomarkers of Effective Tissue Reperfusion After Thrombectomy of an Acute Proximal Occlusion of the Anterior Circulation

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