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

March 6, 2023 updated by: Groupe Hospitalier Paris Saint Joseph

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.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Actual)

65

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75014
        • Groupe Hospitalier Paris Saint-Joseph

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

These patients were referred for suspected stroke, between January 1, 2016, and May 1, 2021. who had a brain MRI including the magnetic susceptibility sequence Patients for whom a blood count with hematocrit was performed at the same time (within a 7-day interval between the MRI and the blood test).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Specific influence of the hematocrit level on the visibility of the venous network
Time Frame: 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.
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inter-observer agreement of the visual analysis of the venous network
Time Frame: Day 1
This outcome corresponds to the correlation of visual scales between different observers.
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe Hospitalier Paris Saint Joseph

Investigators

  • Principal Investigator: Sarah TOLEDANO, MD, Groupe hospitalier Paris saint Joseph

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 13, 2021

Primary Completion (Actual)

December 19, 2021

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

December 30, 2021

First Submitted That Met QC Criteria

December 30, 2021

First Posted (Actual)

January 14, 2022

Study Record Updates

Last Update Posted (Actual)

March 7, 2023

Last Update Submitted That Met QC Criteria

March 6, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HEMAT_SWI

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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