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FRench Acute Cerebral Multimodal Imaging to Select Patient for MEchanical Thrombectomy (FRAME)

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ClinicalTrials.gov Identifier: NCT03045146
Recruitment Status : Active, not recruiting
First Posted : February 7, 2017
Last Update Posted : August 20, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Brief Summary:
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.

Condition or disease Intervention/treatment
Acute Ischemic Stroke Other: Multimodal brain imaging

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.

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Study Type : Observational
Estimated Enrollment : 220 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: FRench Acute Cerebral Multimodal Imaging to Select Patient for MEchanical Thrombectomy
Actual Study Start Date : January 31, 2017
Actual Primary Completion Date : February 8, 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


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.
Other: Multimodal brain imaging
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).




Primary Outcome Measures :
  1. Modified Rankin Scale [ Time Frame: 3 month ]
    Good functional outcome will be defined by a Modified Rankin Scale of 0-2, 3 months after stroke onset


Secondary Outcome Measures :
  1. National Institute of Health Scale [ Time Frame: 24 hours, 3 days, 3 months ]
  2. 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




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03045146


Locations
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France
U H Bordeaux
Bordeaux, France, 33000
University hospital Toulouse
Toulouse, France, 31000
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Principal Investigator: Jean-Marc OLIVOT, MD; PHD UH Toulouse

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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT03045146     History of Changes
Other Study ID Numbers: RC31/15/7832
First Posted: February 7, 2017    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University Hospital, Toulouse:
Acute Ischemic Stroke, Thrombectomy
Additional relevant MeSH terms:
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Stroke
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes