Acute Ischemic StrokeFRAMENCT03045146
FRench Acute Cerebral Multimodal Imaging to Select Patient for MEchanical Thrombectomy
An observational study of Acute Ischemic Stroke, run by University Hospital, Toulouse at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Multimodal brain imaging
- How many people
- 220 participants
- Where
- 2 sitesFrance
- Study dates
- 31 Jan 2017to 30 Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
U H Bordeaux
Bordeaux, 33000
University hospital Toulouse
Toulouse, 31000
About this study
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.
Read the 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.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Multimodal brain imaging
- Keywords
- Acute Ischemic Stroke, Thrombectomy
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal brain imagingOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Multimodal brain imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Rankin Scale
Good functional outcome will be defined by a Modified Rankin Scale of 0-2, 3 months after stroke onset
Measured: 3 month
Secondary outcomes (2)
National Institute of Health Scale
Measured: 24 hours, 3 days, 3 months
Symptomatic Hemorrhagic Transformation
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
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2017 (estimated)
- Study start31 Jan 2017
- Primary completion8 Feb 2019
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Marc OLIVOT, MD; PHD, Principal investigator, UH Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03045146
- Sponsor's protocol ID
- RC31/15/7832
- Acronym
- FRAME
- Status last verified
- Nov 2019
- First submitted
- 13 Dec 2016
- Last updated
- 26 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Fontaine L, Sibon I, Raposo N, Albucher JF, Mazighi M, Rousseau V, Darcourt J, Thalamas C, Drif A, Sommet A, Viguier A, Guenego A, Januel AC, Calviere L, Menegon P, Bonneville F, Tourdias T, Albers GW, Cognard C, Olivot JM; FRAME Investigators*. ASCOD Phenotyping of Stroke With Anterior Large Vessel Occlusion Treated by Mechanical Thrombectomy. Stroke. 2021 Dec;52(12):e769-e772. doi: 10.1161/STROKEAHA.121.035282. Epub 2021 Oct 27.
PubMed 34702062
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FRench Acute Cerebral Multimodal Imaging to Select Patient for MEchanical Thrombectomy
- ClinicalTrials.gov ID
- NCT03045146
- Acronym / sponsor ID
- FRAME / RC31/15/7832
- Conditions
- Acute Ischemic Stroke
- Keywords
- Acute Ischemic Stroke, Thrombectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 31 Jan 2017 (actual)
- Primary completion
- 8 Feb 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 7 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multimodal brain imaging | – | Other: Multimodal brain imagingConsecutive 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multimodal brain imagingComparison 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). | Other | Multimodal brain imaging |
Primary outcome
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
2 secondary outcomes
National Institute of Health Scale
Time frame: 24 hours, 3 days, 3 months
Symptomatic Hemorrhagic Transformation
Time frame: 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2019.
- Derived from this study: PubMed 34702062Fontaine L, Sibon I, Raposo N, Albucher JF, Mazighi M, Rousseau V, Darcourt J, Thalamas C, Drif A, Sommet A, Viguier A, Guenego A, Januel AC, Calviere L, Menegon P, Bonneville F, Tourdias T, Albers GW, Cognard C, Olivot JM; FRAME Investigators*. ASCOD Phenotyping of Stroke With Anterior Large Vessel Occlusion Treated by Mechanical Thrombectomy. Stroke. 2021 Dec;52(12):e769-e772. doi: 10.1161/STROKEAHA.121.035282. Epub 2021 Oct 27.
- Individual participant dataSharing planned: No
Related trials for Acute Ischemic Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
RecruitingObservational study
Continuous Dual Aspiration Technique With Zoom System for Stroke
Ischemic Stroke, Acute Stroke
Not yet recruitingPhase 2/3
A Multicenter, Open-label, Randomized, Non-inferiority Clinical Trial With Blinded Endpoint Assessment of Early Tirofiban After Intravenous Thrombolysis in Acute Ischemic Stroke
Acute Ischemic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Marc OLIVOT, MD; PHD principal investigator
UH Toulouse
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Ischemic Stroke, run by University Hospital, Toulouse at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Rankin Scale (time frame: 3 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03045146, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2019.