Predictive Multimodal MRI Factors in Subacute Cerebral Artery Occlusiontreated by Thrombectomy (PIMISUTT) (PIMISUTT)
Primary Purpose
Middle Cerebral Artery Acute Ischemic Stroke
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Multimodal MRI
Sponsored by
About this trial
This is an interventional prevention trial for Middle Cerebral Artery Acute Ischemic Stroke focused on measuring Ischemic stroke, acute middle cerebral artery occlusion, multimodal MRI, thrombectomy
Eligibility Criteria
Inclusion Criteria:
- 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
- Treated by thrombectomy with or without fibrinolysis
- Written information delivered to the patient or his relatives concerning the study and its benefit and risk
Exclusion Criteria:
- 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
Sites / Locations
- CHU PoitiersRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Multimodal MRI
Arm Description
Outcomes
Primary Outcome Measures
Correlation between modified Rankin score at 3 months and multimodal MRI data
Secondary Outcome Measures
Discharge National Institute of Health Stroke Score (NIHSS)
National Institute of Health Stroke (NIHSS) score at 3 months
Change in NIHSS score at 3 months compared to post-thrombectomy
Full Information
NCT ID
NCT04651010
First Posted
November 25, 2020
Last Updated
February 6, 2023
Sponsor
Poitiers University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04651010
Brief Title
Predictive Multimodal MRI Factors in Subacute Cerebral Artery Occlusiontreated by Thrombectomy (PIMISUTT)
Acronym
PIMISUTT
Official Title
Predictive Multimodal MRI Factors in Subacute Cerebral Artery Occlusiontreated by Thrombectomy (PIMISUTT
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 15, 2021 (Actual)
Primary Completion Date
August 15, 2025 (Anticipated)
Study Completion Date
August 15, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poitiers University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
The treatment of acute ischemic stroke in the setting of intracranial large artery occlusion and especially middle cerebral artery occlusion (MCAO) with intravenous tissue plasminogen activator (IV-tPA) is associated with low rates of recanalization and high rates of neurological morbidity and functional dependence.
In the last few years, endovascular intervention (mechanical thrombectomy) has proven its safety and its efficacy on clinical outcome in patients diagnosed with MCAO and is now commonly recommended.
However, in this population of patients treated by thrombectomy, very few predictive factors, except for the post-procedural recanalization score (TICI), do exist to foresee the variability of clinical outcome.
Tissue viability of the infarcted territory can be approached by the measure of metabolic and morphological parameters (Na+, H+, phosphore, diffusion imaging) which can be non-invasively done by multimodal MRI, as suggest by recently published studies.
Our study plans to measure these parameters between 12 and 24 hours after acute ischemic stroke in patients with MCAO treated by thrombectomy in order to correlate those parameters to clinical outcome at 3 months (modifier Rankin Score).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Middle Cerebral Artery Acute Ischemic Stroke
Keywords
Ischemic stroke, acute middle cerebral artery occlusion, multimodal MRI, thrombectomy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Multimodal MRI
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Multimodal MRI
Intervention Description
Multimodal MRI will be realized between 12 and 24 hours after thrombectomy
Primary Outcome Measure Information:
Title
Correlation between modified Rankin score at 3 months and multimodal MRI data
Time Frame
Month 3
Secondary Outcome Measure Information:
Title
Discharge National Institute of Health Stroke Score (NIHSS)
Time Frame
Month 3
Title
National Institute of Health Stroke (NIHSS) score at 3 months
Time Frame
Month 3
Title
Change in NIHSS score at 3 months compared to post-thrombectomy
Time Frame
Month 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Treated by thrombectomy with or without fibrinolysis
Written information delivered to the patient or his relatives concerning the study and its benefit and risk
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guillaume HERPE, Dr
Phone
05 49 44 33 89
Email
guillaume.herpe@chu-poitiers.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Céline DELETAGE
Phone
05 49 44 38 54
Ext
+33
Email
celine.deletage@chu-poitiers.fr
Facility Information:
Facility Name
CHU Poitiers
City
Poitiers
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guillaume HERPE, Dr
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Predictive Multimodal MRI Factors in Subacute Cerebral Artery Occlusiontreated by Thrombectomy (PIMISUTT)
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