NCT05232500

Brief Summary

Stroke is a public health issue and a priority for our institution. MRI plays an essential role in the management of stroke, its contribution being diagnostic, etiological and prognostic. Among the MRI sequences used in stroke emergencies, the diffusion sequence plays a key role in highlighting ischemic lesions as early as the hyperacute phase, even though the other sequences in the protocol do not reveal any anomaly. This sequence alone conditions the management of patients, particularly in the context of "thrombolysis emergencies". It has been shown that the sensitivity of the diffusion sequence for the detection of ischemic lesions can directly depend on acquisition parameters such as b value, slice thickness or spatial resolution. Recent advances in MRI now allow us to perform diffusion sequences with higher spatial resolution. The matrix is an important acquisition parameter of MRI sequences defining the ability of the sequence to distinguish 2 pixels in the acquisition plane. The higher the matrix, the higher the spatial resolution of the sequence in the acquisition plane. At the Saint-Joseph Hospital, we have a new 3T MRI since September 2020 allowing the acquisition in clinical routine of a more resolved diffusion sequence: 160x200 matrix ("high resolution" diffusion, HR), against 128x140 ("standard" diffusion usually). These two sequences are acquired in particularly short acquisition times (1 minute 37 seconds). This HR diffusion sequence is performed as part of routine care since September 2020 for specific situations: absence of lesion highlighted on the standard diffusion sequence while the patient has a suggestive symptomatology (especially for lesions of the brainstem), search for lesion in other vascular territories (thus in favor of an embolic origin) in a patient who presents an isolated ischemic lesion or ischemic lesions in a single territory. It has been reported in the literature that increasing the spatial resolution can reveal small lesions that were not visible on more conventional sequences. There is a clear rationale for seeking to improve the detection of small lesions (\<5 mm) because their detection may have important therapeutic implications for many patients (particularly in the context of thrombolysis emergencies, transient ischemic attacks, or amnesic strokes).

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
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2023

Shorter than P25 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

First Submitted

Initial submission to the registry

February 1, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 10, 2022

Completed
1.7 years until next milestone

Study Start

First participant enrolled

November 1, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2024

Completed
Last Updated

September 13, 2023

Status Verified

September 1, 2023

Enrollment Period

2 months

First QC Date

February 1, 2022

Last Update Submit

September 11, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Sensitivity of "standard" and "high resolution" diffusion sequences

    This outcome corresponds to the comparison of the number of small (\< 5 mm) acute ischemic lesions visible on standard and high resolution diffusion sequences.

    Day 1

Secondary Outcomes (2)

  • Image quality (SNR) is maintained with this new HR sequence compared to the classic sequence

    Day 1

  • Image quality (CNR) is maintained with this new HR sequence compared to the classic sequence

    Day 1

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

These patients were referred for suspected stroke between September 1, 2020, and July 31, 2021, to the Paris Saint-Joseph Hospital.

You may qualify if:

  • Patients with age ≥ 18 years
  • Patients who underwent a 3T brain MRI for suspected stroke/TIA (MRI performed within 7 days of clinical symptomatology) and for whom the "HR" diffusion sequence was considered useful for diagnosis
  • French-speaking patient

You may not qualify if:

  • Patient under guardianship or curatorship
  • Patient deprived of liberty
  • Patient under court protection
  • Patient objecting to the use of his 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 (5)

  • Powers WJ, Rabinstein AA, Ackerson T, Adeoye OM, Bambakidis NC, Becker K, Biller J, Brown M, Demaerschalk BM, Hoh B, Jauch EC, Kidwell CS, Leslie-Mazwi TM, Ovbiagele B, Scott PA, Sheth KN, Southerland AM, Summers DV, Tirschwell DL; American Heart Association Stroke Council. 2018 Guidelines for the Early Management of Patients With Acute Ischemic Stroke: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2018 Mar;49(3):e46-e110. doi: 10.1161/STR.0000000000000158. Epub 2018 Jan 24.

    PMID: 29367334BACKGROUND
  • Cihangiroglu M, Citci B, Kilickesmez O, Firat Z, Karlikaya G, Ulug AM, Bingol CA, Kovanlikaya I. The utility of high b-value DWI in evaluation of ischemic stroke at 3T. Eur J Radiol. 2011 Apr;78(1):75-81. doi: 10.1016/j.ejrad.2009.10.011. Epub 2009 Nov 13.

    PMID: 19914018BACKGROUND
  • Pereira RS, Harris AD, Sevick RJ, Frayne R. Effect of b value on contrast during diffusion-weighted magnetic resonance imaging assessment of acute ischemic stroke. J Magn Reson Imaging. 2002 May;15(5):591-6. doi: 10.1002/jmri.10105.

    PMID: 11997901BACKGROUND
  • Kim HJ, Choi CG, Lee DH, Lee JH, Kim SJ, Suh DC. High-b-value diffusion-weighted MR imaging of hyperacute ischemic stroke at 1.5T. AJNR Am J Neuroradiol. 2005 Feb;26(2):208-15.

    PMID: 15709115BACKGROUND
  • Benameur K, Bykowski JL, Luby M, Warach S, Latour LL. Higher prevalence of cortical lesions observed in patients with acute stroke using high-resolution diffusion-weighted imaging. AJNR Am J Neuroradiol. 2006 Oct;27(9):1987-9.

    PMID: 17032880BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Jerome HODEL, MD

    Fondation Hôpital Saint-Joseph

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jerome HODEL, MD

CONTACT

Helene BEAUSSIER, PharmD, PhD

CONTACT

Study Design

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

Study Record Dates

First Submitted

February 1, 2022

First Posted

February 10, 2022

Study Start

November 1, 2023

Primary Completion

December 28, 2023

Study Completion

January 31, 2024

Last Updated

September 13, 2023

Record last verified: 2023-09

Locations