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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 : Completed
First Posted : February 7, 2017
Last Update Posted : November 26, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Tracking Information
First Submitted Date December 13, 2016
First Posted Date February 7, 2017
Last Update Posted Date November 26, 2019
Actual Study Start Date January 31, 2017
Actual Primary Completion Date February 8, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 3, 2017)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: February 3, 2017)
  • National Institute of Health Scale [ Time Frame: 24 hours, 3 days, 3 months ]
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title FRench Acute Cerebral Multimodal Imaging to Select Patient for MEchanical Thrombectomy
Official Title FRench Acute Cerebral Multimodal Imaging to Select Patient for MEchanical Thrombectomy
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.
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
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Acute Ischemic Stroke
Intervention 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).
Study Groups/Cohorts 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.
Intervention: Other: Multimodal brain imaging
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 3, 2017)
220
Original Estimated Enrollment Same as current
Actual Study Completion Date April 30, 2019
Actual Primary Completion Date February 8, 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03045146
Other Study ID Numbers RC31/15/7832
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University Hospital, Toulouse
Study Sponsor University Hospital, Toulouse
Collaborators Not Provided
Investigators
Principal Investigator: Jean-Marc OLIVOT, MD; PHD UH Toulouse
PRS Account University Hospital, Toulouse
Verification Date November 2019