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High B Value Diffusion and Stroke (HBS)

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ClinicalTrials.gov Identifier: NCT03923439
Recruitment Status : Recruiting
First Posted : April 22, 2019
Last Update Posted : May 17, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

Tracking Information
First Submitted Date  ICMJE March 25, 2019
First Posted Date  ICMJE April 22, 2019
Last Update Posted Date May 17, 2019
Actual Study Start Date  ICMJE April 1, 2019
Estimated Primary Completion Date February 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 19, 2019)
  • Mean Diffusivity (MD) (in 10-9 m2/s) [ Time Frame: Up to 72 hours ]
    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) [ Time Frame: 3 month of follow-up. ]
    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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03923439 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 19, 2019)
  • Mean Kurtosis (MK) [ Time Frame: Up to 72 hours ]
    Average of the diffusional kurtosis along all diffusion directions
  • Mean Kurtosis (MK) [ Time Frame: 3 month of follow-up ]
    Average of the diffusional kurtosis along all diffusion directions
  • Mean Diffusivity of the slow component (MDs) [ Time Frame: Up to 72 hours ]
    Mean Diffusivity of the slow component (MDs) within the rescued penumbra and within normal contralateral symmetric region
  • Mean Diffusivity of the slow component (MDs) [ Time Frame: 3 month of follow-up ]
    Mean Diffusivity of the slow component (MDs) within the rescued penumbra and within normal contralateral symmetric region
  • Magnetization Transfert Ratio [ Time Frame: Up to 72 hours ]
    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 [ Time Frame: 3 month of follow-up ]
    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
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. 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 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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 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
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  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 19, 2019)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 1, 2021
Estimated Primary Completion Date February 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients older than 18 years old
  • Cerebral infarct within the anterior circulation due to occlusion of intracranial carotid artery or proximal (M1) MCA.
  • 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 (TICI 2b-3) by thrombectomy alone or in combination with IV thrombolysis (if within the first 4.5h).
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Thomas TOURDIAS, Pr 05.56.79.56.04 thomas.tourdias@chu-bordeaux.fr
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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 May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP