Condition or disease | Intervention/treatment | Phase |
---|---|---|
Stroke | Device: Multi-b diffusion sequence MRI | Not Applicable |
Thrombectomy has significantly improved the outcome of stroke patients. However, even after successful recanalization residual handicap including post-stroke cognitive and mood disorders impact the quality of life of patients. These symptoms correlate only moderately with the final stroke volume suggesting more widespread dysfunction than what is apparent on standard follow-up MRI. One hypothesis is that the rescued penumbra (i.e.; the tissue showing significant hypoperfusion at the acute stage but that appears normal on conventional imaging at follow up) could exhibit incomplete ischemic injury also known under the term of selective neuronal loss. The concept of selective neuronal loss in the rescued penumbra is admitted based on histological, animal and PET studies but the identification of such a graduation between pan-necrosis and normal tissue is very challenging to capture in vivo with MRI and is typically missed.
This study will prospectively include 100 stroke patients. Patients admitted with significant penumbra at the acute stage and successfully recanalized thanks to thrombectomy thrombolysis or spontaneously will be explored at 24h-to-72h and then at 3 months with the multi-b diffusion sequence. The investigators expect to be able to measure significant modifications within the rescued penumbra as compared to contralateral normal brain by using the advanced but also the simplified diffusion metrics. Investigators will test the impact of duration/severity of the initial hypoperfusion and they will explore the clinical relevance especially in terms of cognitive and mood disorders as measured at 3 months.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 100 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | High B Value Diffusion and Stroke |
Actual Study Start Date : | April 1, 2019 |
Estimated Primary Completion Date : | April 1, 2021 |
Estimated Study Completion Date : | April 1, 2021 |
Arm | Intervention/treatment |
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Experimental: MRI protocol
For stroke patients, the follow-up MRI (named MRI-2) after successfully recanalized thanks to thrombectomy, intravenous thrombolysis or spontaneously, will be performed between 24h and 72h after recanalization on our new Canon 3T research magnet with high gradient system. Patients will be explored for a follow-up evaluation at 3 months with a final MRI (named MRI-3) that will be performed on the Canon 3T research magnet.
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Device: Multi-b diffusion sequence MRI
Patients will be explored with the multi-b diffusion sequence on a new 3T research magnet equipped with high gradient system.
|
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Thomas TOURDIAS, Pr | 05.56.79.56.04 | thomas.tourdias@chu-bordeaux.fr |
France | |
CHU de Bordeaux | Recruiting |
Bordeaux, France, 33076 | |
Contact: Thomas TOURDIAS 05.56.79.56.04 thomas.tourdias@chu-bordeaux.fr |
Tracking Information | |||||
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First Submitted Date ICMJE | March 25, 2019 | ||||
First Posted Date ICMJE | April 22, 2019 | ||||
Last Update Posted Date | December 20, 2019 | ||||
Actual Study Start Date ICMJE | April 1, 2019 | ||||
Estimated Primary Completion Date | April 1, 2021 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | High B Value Diffusion and Stroke | ||||
Official Title ICMJE | High B Value Diffusion and Stroke | ||||
Brief Summary | This study will include 100 stroke patients with significant penumbra at the acute stage and successfully recanalized thanks to thrombectomy, intravenous thrombolysis or spontaneously. Patients will be explored with the multi-b diffusion sequence on a new 3T research magnet equipped with high gradient system. In this project the investigators hypothesize that diffusion MRI at high and ultra-high b-values could be sensitive enough to quantify selective neuronal loss in the rescued penumbra and to study its relationship with the initial hypoperfusion and its impact in terms of clinical recovery. | ||||
Detailed Description |
Thrombectomy has significantly improved the outcome of stroke patients. However, even after successful recanalization residual handicap including post-stroke cognitive and mood disorders impact the quality of life of patients. These symptoms correlate only moderately with the final stroke volume suggesting more widespread dysfunction than what is apparent on standard follow-up MRI. One hypothesis is that the rescued penumbra (i.e.; the tissue showing significant hypoperfusion at the acute stage but that appears normal on conventional imaging at follow up) could exhibit incomplete ischemic injury also known under the term of selective neuronal loss. The concept of selective neuronal loss in the rescued penumbra is admitted based on histological, animal and PET studies but the identification of such a graduation between pan-necrosis and normal tissue is very challenging to capture in vivo with MRI and is typically missed. This study will prospectively include 100 stroke patients. Patients admitted with significant penumbra at the acute stage and successfully recanalized thanks to thrombectomy thrombolysis or spontaneously will be explored at 24h-to-72h and then at 3 months with the multi-b diffusion sequence. The investigators expect to be able to measure significant modifications within the rescued penumbra as compared to contralateral normal brain by using the advanced but also the simplified diffusion metrics. Investigators will test the impact of duration/severity of the initial hypoperfusion and they will explore the clinical relevance especially in terms of cognitive and mood disorders as measured at 3 months. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Diagnostic |
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Condition ICMJE | Stroke | ||||
Intervention ICMJE | Device: Multi-b diffusion sequence MRI
Patients will be explored with the multi-b diffusion sequence on a new 3T research magnet equipped with high gradient system.
|
||||
Study Arms ICMJE | Experimental: MRI protocol
For stroke patients, the follow-up MRI (named MRI-2) after successfully recanalized thanks to thrombectomy, intravenous thrombolysis or spontaneously, will be performed between 24h and 72h after recanalization on our new Canon 3T research magnet with high gradient system. Patients will be explored for a follow-up evaluation at 3 months with a final MRI (named MRI-3) that will be performed on the Canon 3T research magnet.
Intervention: Device: Multi-b diffusion sequence MRI
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
100 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | April 1, 2021 | ||||
Estimated Primary Completion Date | April 1, 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | France | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03923439 | ||||
Other Study ID Numbers ICMJE | CHUBX 2018/58 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | University Hospital, Bordeaux | ||||
Study Sponsor ICMJE | University Hospital, Bordeaux | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | University Hospital, Bordeaux | ||||
Verification Date | December 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |