StrokeSTROKE_HRNCT05232500
Contribution of a High-resolution Diffusion Sequence at 3T for the Detection of Acute Punctate Ischemic Brain Lesions
An observational study of Stroke, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2023to 31 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: These patients were referred for suspected stroke between September 1, 2020, and July 31, 2021, to the Paris Saint-Joseph Hospital.
Who may be able to join
- 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
Who cannot join
- Patient under guardianship or curatorship
- Patient deprived of liberty
- Patient under court protection
- Patient objecting to the use of his data for this research
Trial locations and contacts
1 site in 1 country.
France1 site
Groupe Hospitalier Paris Saint-Joseph
Paris, 75014
Jerome HODEL, MD, 144127778 ext. +33, jhodel@ghpsj.fr
About this study
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".
Read more
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).
- Conditions
- Stroke
- Medical subject headings
- Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Secondary outcomes (2)
Image quality (SNR) is maintained with this new HR sequence compared to the classic sequence
This outcome corresponds to the comparison of image quality between conventional and high-resolution diffusion sequences by measuring the signal-to-noise ratio (SNR) of ischemic lesions.
Measured: Day 1
Image quality (CNR) is maintained with this new HR sequence compared to the classic sequence
This outcome corresponds to the comparison of image quality between conventional and high-resolution diffusion sequences by measuring the contrast-to-noise ratio (CNR) of ischemic lesions.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start1 Nov 2023 (estimated)
- Primary completion28 Dec 2023 (estimated)
- Study completion31 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jerome HODEL, MD, Principal investigator, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05232500
- Sponsor's protocol ID
- STROKE_HR
- Acronym
- STROKE_HR
- Status last verified
- Sep 2023
- First submitted
- 1 Feb 2022
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 29367334Cihangiroglu 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.
PubMed 19914018Pereira 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.
PubMed 11997901Kim 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.
PubMed 15709115Benameur 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.
PubMed 17032880
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of a High-resolution Diffusion Sequence at 3T for the Detection of Acute Punctate Ischemic Brain Lesions
- ClinicalTrials.gov ID
- NCT05232500
- Acronym / sponsor ID
- STROKE_HR / STROKE_HR
- Conditions
- Stroke
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 28 Dec 2023 (estimated)
- Study completion
- 31 Jan 2024 (estimated)
- First posted
- 10 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- These patients were referred for suspected stroke between September 1, 2020, and July 31, 2021, to the Paris Saint-Joseph Hospital.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Patient under guardianship or curatorship
- Patient deprived of liberty
- Patient under court protection
- Patient objecting to the use of his data for this research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensitivity of "standard" and "high resolution" diffusion sequences
Time frame: Day 1
This outcome corresponds to the comparison of the number of small (< 5 mm) acute ischemic lesions visible on standard and high resolution diffusion sequences.
2 secondary outcomes
Image quality (SNR) is maintained with this new HR sequence compared to the classic sequence
Time frame: Day 1
Image quality (CNR) is maintained with this new HR sequence compared to the classic sequence
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Background: PubMed 29367334Powers 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.
- Background: PubMed 19914018Cihangiroglu 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.
- Background: PubMed 11997901Pereira 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.
- Background: PubMed 15709115Kim 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.
- Background: PubMed 17032880Benameur 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jerome HODEL, MD principal investigator
Fondation Hôpital Saint-Joseph
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Fondation Hôpital Saint-Joseph at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jerome HODEL, MD (144127778 ext. +33, jhodel@ghpsj.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of "standard" and "high resolution" diffusion sequences (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05232500, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.