Stroke, AcuteTOF-SWANNCT03645902
Comparison Between TOF and SWAN Sequences in the Detection of Arterial Occlusion in Acute Ischemic Stroke Using MRI
An observational study of Stroke, Acute and Angiography, run by Lille Catholic University.
Trial summary
Optimizing the MRI protocol in acute ischemic stroke remains a challenging issue. In this field, susceptibility-weighted sequences have proved their superiority over T2. Besides the strengthened susceptibility effect, enhanced susceptibility-weighted angiography (eSWAN) sequence provides also a time-of-flight (TOF)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Acute, Angiography, Magnetic Resonance Imaging
- What is being tested?
- Magnetic resonance imaging
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2014to 31 Dec 2014
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients included in this prospective study will be recruited at Saint-Philibert Hospital -Lomme, France, when presenting symptoms of an acute stroke
Who may be able to join
- clinical symptoms compatible with acute stroke;
- time range between symptoms and magnetic resonance imaging less than 4 h 30
- presence of at least one acute ischemic lesion on the diffusion-weighted images (DWI).
Who cannot join
- MR contraindications;
- negative DWI;
- differential diagnosis;
- incomplete acquisition of the full magnetic resonance imaging protocol or technical issues leading to uninterpretable eSWAN and/or TOF sequences (e.g.motion artifacts).
About this study
Official title: Comparison Between Enhanced Susceptibility-weighted Angiography and Time of Flight Sequences in the Detection of Arterial Occlusion in Acute Ischemic Stroke Using MRI
Optimizing the MRI protocol in acute ischemic stroke remains a challenging issue. In this field, susceptibility-weighted sequences have proved their superiority over T2. Besides the strengthened susceptibility effect, enhanced susceptibility-weighted angiography (eSWAN) sequence provides also a time-of-flight (TOF) effect, allowing the exploration of the intracranial arterial circulation. The objective of this study is to compare eSWAN and 3D TOF, considered as the reference, in the detection of arterial occlusion in acute stroke.
Read the detailed description
Patients who undergo MRI for suspected acute stroke with an acute ischemic lesion on diffusion-weighted imaging (DWI) will be prospectively included in this study.eSWAN and TOF images will be analyzed under double-blind conditions by a junior radiologist and a senior neuroradiologist for the detection of arterial occlusion. eSWAN images will be assessed in order to estimate the inter-observer agreement. After a consensus, eSWAN and TOF data will be compared to calculate inter-modality agreement.
- Conditions
- Stroke, Acute, Angiography, Magnetic Resonance Imaging, Diagnosis
- Being tested
- Magnetic resonance imaging
- Keywords
- Acute stroke, Susceptibility-weighted imaging, Arterial occlusion, Time of flight
- Medical subject headings
- Stroke, Disease, Arterial Occlusive Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic resonance imagingDiagnostic test
| Study group | Role | What they receive |
|---|---|---|
| Acute stroke patients | MRI examinations will be performed on a 3 T GE MR750 W scanner. Two readers, an experienced neuroradiologist (8 years of experience in neuroradiology) and a junior radiologist (3 years of experience in general radiology) will independently analyze eSWAN and TOF images in random order, looking for arterial occlusions. Analysis will be based on a 2-point-scale: arterial occlusion, based on a local signal loss, or acceptable permeability. Receives: Diagnostic Test: Magnetic resonance imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance of observed agreement using eSWAN and TOF images measured by Cohen's kappa coefficient
Concordance of observed agreement for the detection of arterial occlusion between eSWAN and TOF images
Measured: at inclusion
Secondary outcomes (1)
Concordance inter-observer agreement for the detection of arterial occlusion using eSWAN images measured by Cohen's kappa coefficient
Concordance inter-observer agreement between the two readers for the detection of arterial occlusion using eSWAN images
Measured: at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2018
- Study start1 Mar 2014
- Primary completion31 Jul 2014
- Study completion31 Dec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, AcuteStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lille Catholic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sebastien Verclytte, MD, Principal investigator, GHICL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03645902
- Sponsor's protocol ID
- TOF-SWAN
- Acronym
- TOF-SWAN
- Status last verified
- Aug 2018
- First submitted
- 22 Aug 2018
- Last updated
- 24 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Enhanced Susceptibility-weighted Angiography and Time of Flight Sequences in the Detection of Arterial Occlusion in Acute Ischemic Stroke Using MRI
- ClinicalTrials.gov ID
- NCT03645902
- Acronym / sponsor ID
- TOF-SWAN / TOF-SWAN
- Conditions
- Stroke, Acute, Angiography, Magnetic Resonance Imaging, Diagnosis
- Keywords
- Acute stroke, Susceptibility-weighted imaging, Arterial occlusion, Time of flight
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Lille Catholic UniversityUniversity, hospital or other
- Study start
- 1 Mar 2014 (actual)
- Primary completion
- 31 Jul 2014 (actual)
- Study completion
- 31 Dec 2014 (actual)
- First posted
- 24 Aug 2018 (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.
Optimizing the MRI protocol in acute ischemic stroke remains a challenging issue. In this field, susceptibility-weighted sequences have proved their superiority over T2. Besides the strengthened susceptibility effect, enhanced susceptibility-weighted angiography (eSWAN) sequence provides also a time-of-flight (TOF) effect, allowing the exploration of the intracranial arterial circulation. The objective of this study is to compare eSWAN and 3D TOF, considered as the reference, in the detection of arterial occlusion in acute stroke.
Detailed description
Patients who undergo MRI for suspected acute stroke with an acute ischemic lesion on diffusion-weighted imaging (DWI) will be prospectively included in this study.eSWAN and TOF images will be analyzed under double-blind conditions by a junior radiologist and a senior neuroradiologist for the detection of arterial occlusion. eSWAN images will be assessed in order to estimate the inter-observer agreement. After a consensus, eSWAN and TOF data will be compared to calculate inter-modality agreement.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute stroke patients | – | Diagnostic Test: Magnetic resonance imagingMRI examinations will be performed on a 3 T GE MR750 W scanner. Two readers, an experienced neuroradiologist (8 years of experience in neuroradiology) and a junior radiologist (3 years of experience in general radiology) will independently analyze eSWAN and TOF images in random order, looking for arterial occlusions. Analysis will be based on a 2-point-scale: arterial occlusion, based on a local signal loss, or acceptable permeability. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients included in this prospective study will be recruited at Saint-Philibert Hospital -Lomme, France, when presenting symptoms of an acute stroke
Key inclusion criteria (3 listed)
- clinical symptoms compatible with acute stroke;
- time range between symptoms and magnetic resonance imaging less than 4 h 30
- presence of at least one acute ischemic lesion on the diffusion-weighted images (DWI).
Key exclusion criteria (4 listed)
- MR contraindications;
- negative DWI;
- differential diagnosis;
- incomplete acquisition of the full magnetic resonance imaging protocol or technical issues leading to uninterpretable eSWAN and/or TOF sequences (e.g.motion artifacts).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic resonance imaging | Diagnostic test | Acute stroke patients |
Primary outcome
Concordance of observed agreement using eSWAN and TOF images measured by Cohen's kappa coefficient
Time frame: at inclusion
Concordance of observed agreement for the detection of arterial occlusion between eSWAN and TOF images
1 secondary outcome
Concordance inter-observer agreement for the detection of arterial occlusion using eSWAN images measured by Cohen's kappa coefficient
Time frame: at inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2018.
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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.
Sebastien Verclytte, MD principal investigator
GHICL
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, Acute and Angiography, run by Lille Catholic University.
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: finished, as of the sponsor's last update on 24 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concordance of observed agreement using eSWAN and TOF images measured by Cohen's kappa coefficient (time frame: at inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Aug 2018; AzTrials last refreshed its copy on 31 Oct 2026.