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

Stroke Clinical Trial

— HEMAT_SWI  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05192135
• Other study ID #: HEMAT_SWI
• Status: Active, not recruiting
• Start date: September 13, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2023
• Source: Groupe Hospitalier Paris Saint Joseph
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 65
• Est. completion date: December 31, 2023
• Est. primary completion date: December 19, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Disease Susceptibility
• Stroke

Locations

Country	Name	City	State
France	Groupe Hospitalier Paris Saint-Joseph	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier Paris Saint Joseph

Country where clinical trial is conducted

France, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Inter-observer agreement of the visual analysis of the venous network	This outcome corresponds to the correlation of visual scales between different observers.	Day 1