Acute Ischaemic StrokeNCT03971526
Magnetic Resonance Post-contrast Vascular Hyperintensities at 3 T: a Sensitive Sign of Vascular Occlusion in Acute Ischaemic Stroke
An observational study of Acute Ischaemic Stroke, run by Fondation Ophtalmologique Adolphe de Rothschild.
Trial summary
Magnetic resonance imaging (MRI) is the diagnostic cornerstone for precisely identifying acute ischaemic strokes and locating vascular occlusions. It was observed that a post-contrast three-dimensional turbo-spin-echo T1weighted sequence showed striking post-contrast vascular hyperintensities (PCVH) in ischaemic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischaemic Stroke
- What is being tested?
- MRI images review
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2014to 1 Sep 2016
- 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: 130 consecutive patients admitted for acute ischaemic stroke with a 3-T MRI performed in the first 12 h of symptom onset.
Who may be able to join
- Patients aged 18 and older at onset of an acute ischaemic stroke
- Availability of at least one pre-therapeutic MRI performed in our centre within 12 h of stroke onset, including a post-contrast 3D TSE T1-weighted sequence.
Who cannot join
- Patients with posterior fossa strokes
- Patients with known intracranial vasculitis or MoyaMoya disease
- Presence of severe MR imaging artefacts preventing correct interpretation
About this study
Official title: Magnetic Resonance Post-contrast Vascular Hyperintensities at 3 T: a New Highly Sensitive Sign of Vascular Occlusion in Acute Ischaemic Stroke
Magnetic resonance imaging (MRI) is the diagnostic cornerstone for precisely identifying acute ischaemic strokes and locating vascular occlusions.
It was observed that a post-contrast three-dimensional turbo-spin-echo T1weighted sequence showed striking post-contrast vascular hyperintensities (PCVH) in ischaemic territories. The aim is to evaluate the prevalence and the meaning of this finding.
This study included 130 consecutive patients admitted for acute ischaemic stroke with a 3-T MRI performed in the first 12 h of symptom onset from September 2014 through September 2016. Two neuroradiologists blinded to clinical data analysed the first MRI assessments.
- Conditions
- Acute Ischaemic Stroke
- Being tested
- MRI images review
- Keywords
- Cerebrovascular disorders, Magnetic resonance imaging, Neuroimaging, Prognosis, Stroke
- Medical subject headings
- Cerebrovascular Disorders, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI images reviewOther
MR images were reviewed by one junior radiologist and one senior neuroradiologist, both blinded to clinical, therapeutic and follow-up data.
What is being measured
The primary outcome is the main question the study is designed to answer.
overal survival
from the AR-PML diagnosis date to that of death or censored on 31 December 2015
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2019
- Study start1 Sep 2014
- Primary completion1 Sep 2016
- Study completion1 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischaemic StrokeStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03971526
- Sponsor's protocol ID
- 29426989
- Status last verified
- May 2019
- First submitted
- 26 May 2019
- Last updated
- 3 Jun 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Post-contrast Vascular Hyperintensities at 3 T: a New Highly Sensitive Sign of Vascular Occlusion in Acute Ischaemic Stroke
- ClinicalTrials.gov ID
- NCT03971526
- Acronym / sponsor ID
- 29426989
- Conditions
- Acute Ischaemic Stroke
- Keywords
- Cerebrovascular disorders, Magnetic resonance imaging, Neuroimaging, Prognosis, Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 1 Sep 2014 (actual)
- Primary completion
- 1 Sep 2016 (actual)
- Study completion
- 1 Sep 2016 (actual)
- First posted
- 3 Jun 2019 (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.
Magnetic resonance imaging (MRI) is the diagnostic cornerstone for precisely identifying acute ischaemic strokes and locating vascular occlusions.
It was observed that a post-contrast three-dimensional turbo-spin-echo T1weighted sequence showed striking post-contrast vascular hyperintensities (PCVH) in ischaemic territories. The aim is to evaluate the prevalence and the meaning of this finding.
This study included 130 consecutive patients admitted for acute ischaemic stroke with a 3-T MRI performed in the first 12 h of symptom onset from September 2014 through September 2016. Two neuroradiologists blinded to clinical data analysed the first MRI assessments.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 130 consecutive patients admitted for acute ischaemic stroke with a 3-T MRI performed in the first 12 h of symptom onset.
Key inclusion criteria (2 listed)
- Patients aged 18 and older at onset of an acute ischaemic stroke
- Availability of at least one pre-therapeutic MRI performed in our centre within 12 h of stroke onset, including a post-contrast 3D TSE T1-weighted sequence.
Key exclusion criteria (3 listed)
- Patients with posterior fossa strokes
- Patients with known intracranial vasculitis or MoyaMoya disease
- Presence of severe MR imaging artefacts preventing correct interpretation
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 |
|---|---|---|
| MRI images reviewMR images were reviewed by one junior radiologist and one senior neuroradiologist, both blinded to clinical, therapeutic and follow-up data. | Other | – |
Primary outcome
overal survival
Time frame: 7 years
from the AR-PML diagnosis date to that of death or censored on 31 December 2015
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 3 Jun 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Ischaemic Stroke, run by Fondation Ophtalmologique Adolphe de Rothschild.
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 2 inclusion and 3 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 3 Jun 2019. 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?
overal survival (time frame: 7 years). 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 3 Jun 2019.