Characterization of Peri-Hemorrhagic Cerebral Edema Using Synthetic Sodium Imaging With 7-Tesla and 3-Tesla MRI

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity Hospital, Lille

About this trial

Intracerebral haemorrhage is the type of stroke with the highest mortality rate, estimated at 40% in the acute phase. Among survivors, half will experience functional disability. Currently, there is no validated effective treatment. Reduction of perihematomal oedema is a potential therapeutic target. The development of oedema in the days following the haemorrhage worsens functional prognosis, notably through a harmful inflammatory process. In the early phase, neuronal excitotoxicity induced by the hematoma plays a major role in triggering the inflammatory cascade. This phenomenon is associated with dysfunction of neuronal Na⁺/K⁺ ATPase pumps and a disturbance of cerebral sodium homeostasis. Ultra-high field 7T MRI enables in vivo quantification of brain sodium concentrations. The investigators hypothesize that a drop-in sodium concentration within the perihematomal oedema is associated with greater oedema expansion and poorer functional outcome. To make this biomarker accessible to centers without 7 Tesla MRI, the investigators will use an artificial intelligence algorithm to generate synthetic sodium concentration maps derived from data acquired on conventional 3 Tesla MRI.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged between 18 and 80 years old;

presenting for a first-ever or recurrent symptomatic supratentorial spontaneous ICH within 8 (±2) days after symptoms onset (or last seen well) and confirmed by brain imaging; presumed to be related to small vessel disease.

Patient/legal representative/trusted person who has given written consent to participate in the trial;

Patient covered by social security in France

Disqualifiers

Contra-indication for MRI;

pre-admission disabilities (mRs > 4);

large ICH of 60 ml or more;

NIH Stroke Scale score > 20;

Trial design

Design model

Single group

Treatments tested in this trial

  • Sodium tissue concentration will be measured in perihematomal oedema

    Device

    Sodium tissue concentration will be measured in perihematomal oedema

Treatment groups

48 Participants
are divided into 1 treatment group
Group A: 7Tesla Sodium MRIExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Intraclass coefficient correlation (ICC)

Intraclass coefficient correlation (ICC) between sodium concentration measured at 7T and synthetic sodium concentration calculated from 3T images assessed at day-8 after ICH onset.

Time frame
Baseline visit

Secondary outcomes

1

Correlation coefficients of 6-month disability degree and sodium concentration.

Correlation coefficients of 6-month disability degree assessed by modified Rankin scale (mRS) with 7T and 3T synthetic sodium concentration at day-8 after ICH onset.

Time frame
Baseline and 6-month visit

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Lille

Lead sponsor

Lille University

Collaborator

Lille In vivo Imaging and Functional Exploration

Collaborator

This trial is not recruiting at the moment. You can still explore other options: