search
Back to results

High B Value Diffusion and Stroke (HBS)

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Multi-b diffusion sequence MRI
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Stroke focused on measuring Stroke, High b-value diffusion MRI, Rescued penumbra, Selective neuronal loss.

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients older than 18 years old
  • Cerebral infarct or cerebral hypoperfusion with neurological symptoms within the anterior circulation
  • Due to occlusion or stenosis of intracranial carotid artery or its branches and/or middle cerebral artery (MCA) and/or anterior cerebral artery.
  • With acute MRI performed within the first 24h and showing significant penumbra defined as ratio between the volumes of critically hypoperfused tissue (defined by Tmax>6s) and the ischemic core (defined by ADC<600 × 10-6 mm2/s) of 1.8 or more, with an absolute difference of 15 mL or more and ischemic core volume of less than 70 mL.
  • Successful recanalization by thrombectomy (TICI 2b or 2c or 3) and/or by IV thrombolysis (if within the first 4.5h) or spontaneously.
  • Patient/Legally Authorized Representative has signed the Informed Consent form.

Exclusion Criteria:

  • History of symptomatic cerebral infarct with functional deficit (pre-stroke modified Rankin Scale score ≥1) to measure the impact of the infarct and selective neuronal loss on long-term outcome without being biased by pre-existing deficits.
  • History of severe cognitive impairment (dementia) or DSMIV axis 1 psychiatric disorders that would confound the neurological evaluations.
  • Pregnant or breast-feeding women.
  • Contraindications to MRI.

Sites / Locations

  • CHU de Bordeaux

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MRI protocol

Arm Description

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.

Outcomes

Primary Outcome Measures

Mean Diffusivity (MD) (in 10-9 m2/s)
Computation of Mean Diffusivity (MD) metrics (in 10-9 m2/s) including MDlow for b=1000s/mm2 and pseudo-MDhigh for maps calculated from the highest b-values within the rescued penumbra and within normal contralateral symmetric region of the brain
Mean Diffusivity (MD) (in 10-9 m2/s)
Computation of Mean Diffusivity (MD) metrics (in 10-9 m2/s) including MDlow for b=1000s/mm2 and pseudo-MDhigh for maps calculated from the highest b-values within the rescued penumbra and within normal contralateral symmetric region of the brain

Secondary Outcome Measures

Mean Kurtosis (MK)
Average of the diffusional kurtosis along all diffusion directions
Mean Kurtosis (MK)
Average of the diffusional kurtosis along all diffusion directions
Mean Diffusivity of the slow component (MDs)
Mean Diffusivity of the slow component (MDs) within the rescued penumbra and within normal contralateral symmetric region
Mean Diffusivity of the slow component (MDs)
Mean Diffusivity of the slow component (MDs) within the rescued penumbra and within normal contralateral symmetric region
Magnetization Transfert Ratio
Magnetization Transfert Ratio maps (MTR=(0-Ms)/M0 x100 where M0 and Ms represent the signal intensity with the saturation prepulse off and on, respectively) within the rescued penumbra and within normal contralateral symmetric region of the brain
Magnetization Transfert Ratio
Magnetization Transfert Ratio maps (MTR=(0-Ms)/M0 x100 where M0 and Ms represent the signal intensity with the saturation prepulse off and on, respectively) within the rescued penumbra and within normal contralateral symmetric region of the brain

Full Information

First Posted
March 25, 2019
Last Updated
July 12, 2022
Sponsor
University Hospital, Bordeaux
search

1. Study Identification

Unique Protocol Identification Number
NCT03923439
Brief Title
High B Value Diffusion and Stroke
Acronym
HBS
Official Title
High B Value Diffusion and Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
June 21, 2022 (Actual)
Study Completion Date
June 21, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, High b-value diffusion MRI, Rescued penumbra, Selective neuronal loss.

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MRI protocol
Arm Type
Experimental
Arm Description
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 Type
Device
Intervention Name(s)
Multi-b diffusion sequence MRI
Intervention Description
Patients will be explored with the multi-b diffusion sequence on a new 3T research magnet equipped with high gradient system.
Primary Outcome Measure Information:
Title
Mean Diffusivity (MD) (in 10-9 m2/s)
Description
Computation of Mean Diffusivity (MD) metrics (in 10-9 m2/s) including MDlow for b=1000s/mm2 and pseudo-MDhigh for maps calculated from the highest b-values within the rescued penumbra and within normal contralateral symmetric region of the brain
Time Frame
Up to 72 hours
Title
Mean Diffusivity (MD) (in 10-9 m2/s)
Description
Computation of Mean Diffusivity (MD) metrics (in 10-9 m2/s) including MDlow for b=1000s/mm2 and pseudo-MDhigh for maps calculated from the highest b-values within the rescued penumbra and within normal contralateral symmetric region of the brain
Time Frame
3 month of follow-up.
Secondary Outcome Measure Information:
Title
Mean Kurtosis (MK)
Description
Average of the diffusional kurtosis along all diffusion directions
Time Frame
Up to 72 hours
Title
Mean Kurtosis (MK)
Description
Average of the diffusional kurtosis along all diffusion directions
Time Frame
3 month of follow-up
Title
Mean Diffusivity of the slow component (MDs)
Description
Mean Diffusivity of the slow component (MDs) within the rescued penumbra and within normal contralateral symmetric region
Time Frame
Up to 72 hours
Title
Mean Diffusivity of the slow component (MDs)
Description
Mean Diffusivity of the slow component (MDs) within the rescued penumbra and within normal contralateral symmetric region
Time Frame
3 month of follow-up
Title
Magnetization Transfert Ratio
Description
Magnetization Transfert Ratio maps (MTR=(0-Ms)/M0 x100 where M0 and Ms represent the signal intensity with the saturation prepulse off and on, respectively) within the rescued penumbra and within normal contralateral symmetric region of the brain
Time Frame
Up to 72 hours
Title
Magnetization Transfert Ratio
Description
Magnetization Transfert Ratio maps (MTR=(0-Ms)/M0 x100 where M0 and Ms represent the signal intensity with the saturation prepulse off and on, respectively) within the rescued penumbra and within normal contralateral symmetric region of the brain
Time Frame
3 month of follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients older than 18 years old Cerebral infarct or cerebral hypoperfusion with neurological symptoms within the anterior circulation Due to occlusion or stenosis of intracranial carotid artery or its branches and/or middle cerebral artery (MCA) and/or anterior cerebral artery. With acute MRI performed within the first 24h and showing significant penumbra defined as ratio between the volumes of critically hypoperfused tissue (defined by Tmax>6s) and the ischemic core (defined by ADC<600 × 10-6 mm2/s) of 1.8 or more, with an absolute difference of 15 mL or more and ischemic core volume of less than 70 mL. Successful recanalization by thrombectomy (TICI 2b or 2c or 3) and/or by IV thrombolysis (if within the first 4.5h) or spontaneously. Patient/Legally Authorized Representative has signed the Informed Consent form. Exclusion Criteria: History of symptomatic cerebral infarct with functional deficit (pre-stroke modified Rankin Scale score ≥1) to measure the impact of the infarct and selective neuronal loss on long-term outcome without being biased by pre-existing deficits. History of severe cognitive impairment (dementia) or DSMIV axis 1 psychiatric disorders that would confound the neurological evaluations. Pregnant or breast-feeding women. Contraindications to MRI.
Facility Information:
Facility Name
CHU de Bordeaux
City
Bordeaux
ZIP/Postal Code
33076
Country
France

12. IPD Sharing Statement

Learn more about this trial

High B Value Diffusion and Stroke

We'll reach out to this number within 24 hrs