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

Sponsor
Central Hospital, Nancy, France (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04952077
Collaborator
(none)
40
1
24

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: MRI
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
MRI Biomarkers of Effective Tissue Reperfusion After Thrombectomy of an Acute Proximal Occlusion of the Anterior Circulation: MR-Reperfusion Longitudinal Study
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Feb 28, 2024
Anticipated Study Completion Date :
Aug 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental

Device: MRI
Magnetic Resonance Imaging (MRI)

Outcome Measures

Primary Outcome Measures

  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 Outcome Measures

  1. 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]

  2. 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]

  3. 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]

  4. 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Central Hospital, Nancy, France

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Liang LIAO, Principal Investigator, Central Hospital, Nancy, France
ClinicalTrials.gov Identifier:
NCT04952077
Other Study ID Numbers:
  • 2021-A00716-35
First Posted:
Jul 7, 2021
Last Update Posted:
Feb 1, 2022
Last Verified:
Jan 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 1, 2022