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High B Value Diffusion and Stroke

High B Value Diffusion and Stroke

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03923439
Acronym
HBS
Enrollment
56
Registered
2019-04-22
Start date
2019-04-01
Completion date
2022-06-21
Last updated
2026-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

Stroke, High b-value diffusion MRI, Rescued penumbra, Selective neuronal loss.

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.

Interventions

DEVICEMulti-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.

Sponsors

University Hospital, Bordeaux
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Mean Diffusivity (MD) (in 10-9 m2/s)Up to 72 hoursComputation 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

MeasureTime frameDescription
Mean Kurtosis (MK)Up to 72 hoursAverage of the diffusional kurtosis along all diffusion directions
Mean Diffusivity of the slow component (MDs)Up to 72 hoursMean Diffusivity of the slow component (MDs) within the rescued penumbra and within normal contralateral symmetric region
Magnetization Transfert RatioUp to 72 hoursMagnetization 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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 3, 2026