Cerebral InfarctionNCT03467269
BRUSH Sign: Radiolographic Marker of Cerebral Infarctus Prognosis
An observational study of Cerebral Infarction, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
Today the treatment of ischemic stroke in acute phase is based on medicinal or endovascular revascularization. Cerebral MRI sequences help the diagnostic. This procedure uses deoxyhemoglobin as an endogenous tracer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Infarction
- What is being tested?
- Brush sign
- How many people
- 250 participants
- Where
- 1 siteFrance
- Study dates
- 24 Feb 2017to 30 Jun 2017
- 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: patient hospitalized between april 2014 and august 2016 for cerebral infarction
Who may be able to join
- age>18 years old
- hospitalized for cerebral infarction
- MCA territory
- MRI within 24hours
- Sequence of magnetic susceptibility (SWAN)
Who cannot join
- Incomplete cerebral infarct
- MRI not possible
Trial locations and contacts
1 site in 1 country.
France1 site
Groupe Hospitalier Paris Saint Joseph
Paris, Île-de-France Region, 75014
About this study
Today the treatment of ischemic stroke in acute phase is based on medicinal or endovascular revascularization. Cerebral MRI sequences help the diagnostic. This procedure uses deoxyhemoglobin as an endogenous tracer. This is also a scorer of cerebral ischemia and the increase lets visualized transcerebral veins in the suffering zone giving a brush aspect. Several studies show the interest of this sign and conclude that deoxyhemoglobin presence is a predictive factor of cerebral ischemia. The aim of the study is to evaluate this brush-sign and correlate it with the prognosis retrospectively.
- Conditions
- Cerebral Infarction
- Being tested
- Brush sign
- Medical subject headings
- Cerebral Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brush signDiagnostic test
presence of a brush sign in MRI image in acute cerebral ischaemia
What is being measured
The primary outcome is the main question the study is designed to answer.
autonomy level
measurement of autonomy level by mRS
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2018
- Study start24 Feb 2017
- Primary completion1 Apr 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral InfarctionStudies 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
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ZUBER Mathieu, Professor, Principal investigator, GHPSJ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03467269
- Sponsor's protocol ID
- BRUSH SIGN
- Status last verified
- Mar 2018
- First submitted
- 9 Mar 2018
- Last updated
- 15 Mar 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 15 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BRUSH Sign: Radiolographic Marker of Cerebral Infarctus Prognosis
- ClinicalTrials.gov ID
- NCT03467269
- Acronym / sponsor ID
- BRUSH SIGN
- Conditions
- Cerebral Infarction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 24 Feb 2017 (actual)
- Primary completion
- 1 Apr 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 15 Mar 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.
Today the treatment of ischemic stroke in acute phase is based on medicinal or endovascular revascularization. Cerebral MRI sequences help the diagnostic. This procedure uses deoxyhemoglobin as an endogenous tracer. This is also a scorer of cerebral ischemia and the increase lets visualized transcerebral veins in the suffering zone giving a brush aspect. Several studies show the interest of this sign and conclude that deoxyhemoglobin presence is a predictive factor of cerebral ischemia. The aim of the study is to evaluate this brush-sign and correlate it with the prognosis retrospectively.
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
- patient hospitalized between april 2014 and august 2016 for cerebral infarction
Key inclusion criteria (5 listed)
- age>18 years old
- hospitalized for cerebral infarction
- MCA territory
- MRI within 24hours
- Sequence of magnetic susceptibility (SWAN)
Key exclusion criteria (2 listed)
- Incomplete cerebral infarct
- MRI not possible
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 |
|---|---|---|
| Brush signpresence of a brush sign in MRI image in acute cerebral ischaemia | Diagnostic test | – |
Primary outcome
autonomy level
Time frame: Month 3
measurement of autonomy level by mRS
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 15 Mar 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.
ZUBER Mathieu, Professor principal investigator
GHPSJ
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 Cerebral Infarction, 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 5 inclusion and 2 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 15 Mar 2018. 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?
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?
autonomy level (time frame: Month 3). 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 15 Mar 2018.