NCT05192135

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
65

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 13, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2021

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

December 30, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 14, 2022

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

March 7, 2023

Status Verified

March 1, 2023

Enrollment Period

3 months

First QC Date

December 30, 2021

Last Update Submit

March 6, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Specific influence of the hematocrit level on the visibility of the venous network

    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 Outcomes (1)

  • Inter-observer agreement of the visual analysis of the venous network

    Day 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groupe Hospitalier Paris Saint-Joseph

Paris, 75014, France

Location

Related Publications (6)

  • Haacke EM, Mittal S, Wu Z, Neelavalli J, Cheng YC. Susceptibility-weighted imaging: technical aspects and clinical applications, part 1. AJNR Am J Neuroradiol. 2009 Jan;30(1):19-30. doi: 10.3174/ajnr.A1400. Epub 2008 Nov 27.

    PMID: 19039041BACKGROUND
  • Mittal S, Wu Z, Neelavalli J, Haacke EM. Susceptibility-weighted imaging: technical aspects and clinical applications, part 2. AJNR Am J Neuroradiol. 2009 Feb;30(2):232-52. doi: 10.3174/ajnr.A1461. Epub 2009 Jan 8.

    PMID: 19131406BACKGROUND
  • Chalian M, Tekes A, Meoded A, Poretti A, Huisman TA. Susceptibility-weighted imaging (SWI): a potential non-invasive imaging tool for characterizing ischemic brain injury? J Neuroradiol. 2011 Jul;38(3):187-90. doi: 10.1016/j.neurad.2010.12.006. Epub 2011 Feb 26.

    PMID: 21354625BACKGROUND
  • Wang Y, Shi T, Chen B, Lin G, Xu Y, Geng Y. Prominent Hypointense Vessel Sign on Susceptibility-Weighted Imaging Is Associated with Clinical Outcome in Acute Ischaemic Stroke. Eur Neurol. 2018;79(5-6):231-239. doi: 10.1159/000488587. Epub 2018 Apr 19.

    PMID: 29672289BACKGROUND
  • Horie N, Morikawa M, Nozaki A, Hayashi K, Suyama K, Nagata I. "Brush Sign" on susceptibility-weighted MR imaging indicates the severity of moyamoya disease. AJNR Am J Neuroradiol. 2011 Oct;32(9):1697-702. doi: 10.3174/ajnr.A2568. Epub 2011 Jul 28.

    PMID: 21799039BACKGROUND
  • Winchell AM, Taylor BA, Song R, Loeffler RB, Grundlehner P, Hankins JS, Wang WC, Ogg RJ, Hillenbrand CM, Helton KJ. Evaluation of SWI in children with sickle cell disease. AJNR Am J Neuroradiol. 2014 May;35(5):1016-21. doi: 10.3174/ajnr.A3794. Epub 2013 Nov 21.

    PMID: 24263696BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Sarah TOLEDANO, MD

    Fondation Hôpital Saint-Joseph

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 30, 2021

First Posted

January 14, 2022

Study Start

September 13, 2021

Primary Completion

December 19, 2021

Study Completion

December 31, 2023

Last Updated

March 7, 2023

Record last verified: 2023-03

Locations