- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03045146
FRench Acute Cerebral Multimodal Imaging to Select Patient for MEchanical Thrombectomy (FRAME)
November 25, 2019 updated by: University Hospital, Toulouse
FRench Acute cerebral multimodal imaging to select patient for MEchanical thrombectomy is a prospective multi-center study to determine if multimodal imaging could identify patients who may and those who may not benefit from an endovascular clot removal procedure within 6 hours after stroke onset.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Emergent cerebral artery recanalization by thrombectomy within 6 hours after symptom onset is n the standard of care of an acute hemispheric infarction with a documented proximal internal carotid artery and/middle cerebral artery occlusion.
The success of vessel revascularization is mostly related to the emergent reperfusion of the ischemic penumbra.
Multimodal brain imaging can identify the amount of salvageable penumbra.
The indirect comparison of the recently published randomized trials suggests that despite common baseline clinical characteristics, (vessel site occlusion, delay and type of treatment), the success of thrombectomy was higher in studies enrolling exclusively patients exhibiting a significant amount of penumbra defined by a target mismatch (TMM) on CTP or MRI by comparison with those enrolling patients based on non contrast CT scan without specific imaging criteria.
As the prevalence of TMM has not been systematically evaluated in those trials, as TMM definition differs according to the studies and as there has been no prospective estimation of the impact of the prevalence of TMM on baseline imaging assessed blindly of clinical outcome, there is currently no demonstration that mechanical thrombectomy has to be limited to the subgroup of patients based on imaging criteria.
With this as a background, we aim to investigate in a prospective cohort of patients treated by thrombectomy according to the current recommendations, the relationship between the prevalence of TMM on pretreatment brain imaging with the rate of clinical recovery after thrombectomy.
MR DWI, perfusion and CTP maps processed by RAPID software will not be as usual pushed back to the PACS but anonymized and saved on a remote software leaving the investigator blinded at the time of treatment decision.
We hope to learn whether MR or CTP can help to define an imaging profile to select the subgroup of patients that will benefit from thrombectomy.
Study Type
Observational
Enrollment (Actual)
220
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Bordeaux, France, 33000
- U H Bordeaux
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Toulouse, France, 31000
- University Hospital Toulouse
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients experiencing an anterior circulation brain infarction complicating the occlusion of the internal carotid artery or the first or second segment of the middle cerebral artery
Description
Inclusion Criteria:
- Patients experiencing an anterior circulation brain infarction complicating the occlusion of the internal carotid artery or the first or second segment of the middle cerebral artery, as seen on CT or MR angiography, undergoing a multimodal brain imaging (DWI/PWI MRI or CTP) prior to a mechanical thrombectomy initiated within 6 hours after onset according to the current guidelines.
- Age ≥ 18 ans.
- Mechanical thrombectomy initiated within 6 hours after onset.
- Eligible patients may receive IV thrombolysis with rtPA within 4.5 hours after onset.
- Affiliation to the french social security.
- Patients undergoing multimodal brain imaging MRI : DWI and PWI, or CTP before the initiation of thrombectomy.
- Signature of the informed consent within 24 hours after treatment
Exclusion Criteria:
- Modified Rankin Scale estimated before the occurrence of brain infarction > 1.
- Inability to access the cerebral vasculature in the opinion of the neuro-interventional team.
- Contraindication to imaging with contrast agents.
- Any terminal illness such that patient would not be expected to survive more than one-year.
- Delay between imaging and beginning of thrombectomy > 90 minutes.
- Evaluation of the presence of Target Mismatch on MRI or CTP before treatment
- Patients placed under guardianship, curators and analogous institutions
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Multimodal brain imaging
Consecutive patients experiencing an acute ischemic stroke treated by thrombectomy according to the current recommendations.
Clinical outcome will be compared according to the baseline imaging profile processed after patient treatment.
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Comparison of the Rate of Good Neurological Functional Outcome defined by Modified Rankin Scale 0-2, 3 Months after an acute ischemic stroke treated by thrombectomy according to the presence or not of a Target Mismatch on Baseline imaging (MRI or CTP).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Modified Rankin Scale
Time Frame: 3 month
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Good functional outcome will be defined by a Modified Rankin Scale of 0-2, 3 months after stroke onset
|
3 month
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
National Institute of Health Scale
Time Frame: 24 hours, 3 days, 3 months
|
24 hours, 3 days, 3 months
|
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Symptomatic Hemorrhagic Transformation
Time Frame: 72 hours
|
Symptomatic hemorrhagic transformation is defined by an intra cerebral hemorrhage associated with a 4 or more point increase on the NIH Stroke Scale by comparison with NIH Stroke Scale immediately predeterioration. Date and time of onset will be recorded |
72 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jean-Marc OLIVOT, MD; PHD, Uh Toulouse
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 31, 2017
Primary Completion (Actual)
February 8, 2019
Study Completion (Actual)
April 30, 2019
Study Registration Dates
First Submitted
December 13, 2016
First Submitted That Met QC Criteria
February 3, 2017
First Posted (Estimate)
February 7, 2017
Study Record Updates
Last Update Posted (Actual)
November 26, 2019
Last Update Submitted That Met QC Criteria
November 25, 2019
Last Verified
November 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC31/15/7832
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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