High B Value Diffusion and Stroke

NCT03923439 | Completed

• 1 other identifier: CHUBX 2018/58
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

  Up to 72 hours

• 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

  3 month of follow-up.

Secondary Outcomes (6)

• Mean Kurtosis (MK)

  Up to 72 hours

• Mean Kurtosis (MK)

  3 month of follow-up

• Mean Diffusivity of the slow component (MDs)

  Up to 72 hours

• Mean Diffusivity of the slow component (MDs)

  3 month of follow-up

• Magnetization Transfert Ratio

  Up to 72 hours

Study Arms (1)

MRI protocol

EXPERIMENTAL

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.

Device: Multi-b diffusion sequence MRI

Interventions

Multi-b diffusion sequence MRI DEVICE

Patients will be explored with the multi-b diffusion sequence on a new 3T research magnet equipped with high gradient system.

MRI protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

CHU de Bordeaux

Bordeaux, 33076, France

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2019
• First Posted: April 22, 2019
• Study Start: April 1, 2019
• Primary Completion: June 21, 2022
• Study Completion: June 21, 2022
• Last Updated: July 14, 2022

Record last verified: 2022-07

Locations

FR (1)