HEMAT_SWI: Influence of Hematocrit Level on the Visibility of the Venous Network in Magnetic Susceptibility Imaging

Sponsor

Groupe Hospitalier Paris Saint Joseph (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05192135

Collaborator

(none)

Enrollment

Location

15.6

Anticipated Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Magnetic susceptibility imaging is a magnetic resonance imaging (MRI) technique that uses the magnetic properties of tissues and the BOLD (blood oxygen level-dependent) effect. It allows a better visualization of venous structures and hemorrhagic lesions. These sequences are now used in clinical routine.

The extreme sensitivity of these sequences to the oxy/deoxyhemoglobin ratio makes it possible to describe a new MRI semiology, particularly in the context of cerebral ischemia. The interest of the analysis of the venous network signal, which can reflect cerebral perfusion, has been reported.

However, the influence of the hematocrit level on the signal of the venous network in magnetic susceptibility imaging has not been evaluated at present. It seems important to better define the influence of hematocrit level on the signal of the veins with this sequence to avoid potential diagnostic errors.

Condition or Disease	Intervention/Treatment	Phase
Stroke

Study Design

Study Type:

Observational

Actual Enrollment :

65 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Influence of Hematocrit Level on the Visibility of the Venous Network in Magnetic Susceptibility Imaging

Actual Study Start Date :

Sep 13, 2021

Actual Primary Completion Date :

Dec 19, 2021

Anticipated Study Completion Date :

Dec 31, 2022

Outcome Measures

Primary Outcome Measures

Specific influence of the hematocrit level on the visibility of the venous network [Day 1]
This outcome corresponds to the visibility of the venous network in magnetic susceptibility imaging using a visual scale allowing comparison between patients with normal hematocrit, anemia or polycythemia.

Secondary Outcome Measures

Inter-observer agreement of the visual analysis of the venous network [Day 1]
This outcome corresponds to the correlation of visual scales between different observers.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patient whose age ≥ 18 years
Patient referred to GHPSJ for suspected stroke
Patient who had a brain MRI including the magnetic susceptibility sequence
Patient for whom a blood count with hematocrit was performed at the same time (within 7 days between the MRI and the blood test)
French-speaking patient

Exclusion Criteria:

Patient under guardianship or curatorship
Patient deprived of liberty
Patient under court protection
Elimination of potential biases: recent injection (48 h) of gadolinium, pathology likely to modify the venous signal in magnetic susceptibility imaging (notably arterial occlusion or stenosis), high flow oxygenation, sickle cell disease, thalassemia.
Patient objecting to the use of his/her data for this research

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Groupe Hospitalier Paris Saint-Joseph	Paris		France	75014

Sponsors and Collaborators

Groupe Hospitalier Paris Saint Joseph

Investigators

Principal Investigator: Sarah TOLEDANO, MD, Groupe Hospitalier Paris Saint Joseph

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Groupe Hospitalier Paris Saint Joseph

ClinicalTrials.gov Identifier:

NCT05192135

Other Study ID Numbers:

HEMAT_SWI

First Posted:

Jan 14, 2022

Last Update Posted:

Jan 14, 2022

Last Verified:

Dec 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Disease Susceptibility

Study Results

No Results Posted as of Jan 14, 2022