Clinical trial NCT04952077: MRI Biomarkers of Effective Tissue Reperfusion After Thrombectomy of an Acute Proximal Occlusion of the Anterior Circulation
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
Overall status: UNKNOWN
Phase: NA
Conditions: Ischemic Stroke, Acute
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2021-07-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: 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
timeFrame: Admission to hospital, 3 hours, 24 hours, 7 days and 3 months after thrombectomy
Secondary outcomes:
measure: 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)
timeFrame: Admission to hospital, 3 hours, 24 hours, 7 days and 3 months after thrombectomy
measure: Kinetic evolution of the NIHSS score and its correlation with the functional prognosis at 3 months evaluated by the mRS score.
timeFrame: Admission to hospital, 3 hours, 24 hours, 7 days and 3 months after thrombectomy
measure: 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)
timeFrame: 24 hours after thrombectomy
measure: 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
timeFrame: 3 months after thrombectomy
Other outcomes:
Locations:
city: Nancy
country: France
facility: CHRU Nancy
Study officials:
References: