StrokePATTERNNCT03611894
Comparison of the Radiological Pattern Between the Cerebral Stroke of Arterial and Venous Origin
An observational study of Stroke and Superior Sagittal Sinus Thrombosis, run by Centre Hospitalier Universitaire, Amiens at 2 sites in France.
Trial summary
There are few published data on the patterns of parenchymal imaging abnormalities in a context of cerebral venous thrombosis (CVT). The objectives of the present study were to describe the patterns of parenchymal lesions associated with CVT and to determine the lesion sites. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Superior Sagittal Sinus Thrombosis, Venous Thromboses
- What is being tested?
- radiological comparison
- How many people
- 98 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Jan 2017to 1 Jul 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
- No healthy volunteers
- Adult, Older adult
Study population: The investigators want to include consecutively hospitalized patients with CVT and parenchymal lesions on magnetic resonance imaging.
Who may be able to join
- hospitalized patients with CVT
- parenchymal lesions on magnetic resonance imaging
Who cannot join
- No CVT
Trial locations and contacts
2 sites in 1 country.
About this study
There are few published data on the patterns of parenchymal imaging abnormalities in a context of cerebral venous thrombosis (CVT). The objectives of the present study were to describe the patterns of parenchymal lesions associated with CVT and to determine the lesion sites.
- Being tested
- radiological comparison
- Keywords
- RMI
- Medical subject headings
- Stroke, Sagittal Sinus Thrombosis, Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiological comparisonOther
comparison between clinical and radiological characteristics
| Study group | Role | What they receive |
|---|---|---|
| hemorrhagic ischemia | comparison between clinical characteristics and the confirmed diagnosis by RMI (magnetic resonance Imaging) Receives: Other: radiological comparison | |
| nonhemorrhagic ischemia | comparison between clinical characteristics and the confirmed diagnosis by RMI (magnetic resonance Imaging) Receives: Other: radiological comparison | |
| intracerebral hematoma | comparison between clinical characteristics and the confirmed diagnosis by RMI (magnetic resonance Imaging) Receives: Other: radiological comparison |
What is being measured
The primary outcome is the main question the study is designed to answer.
patterns
describe the patterns of parenchymal lesions associated with CVT and to determine the lesion sites.
Measured: 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2018
- Study start1 Jan 2017
- Primary completion1 Jul 2017
- Study completion1 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Audrey Arnoux, MD, Principal investigator, CHU Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03611894
- Sponsor's protocol ID
- PI2017_843_0035
- Acronym
- PATTERN
- Status last verified
- Jul 2018
- First submitted
- 27 Jul 2018
- Last updated
- 2 Aug 2018
- Results posted
- No
- Data monitoring committee
- 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 2 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Radiological Pattern Between the Cerebral Stroke of Arterial and Venous Origin
- ClinicalTrials.gov ID
- NCT03611894
- Acronym / sponsor ID
- PATTERN / PI2017_843_0035
- Keywords
- RMI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jul 2017 (actual)
- Study completion
- 1 Jul 2017 (actual)
- First posted
- 2 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.
There are few published data on the patterns of parenchymal imaging abnormalities in a context of cerebral venous thrombosis (CVT). The objectives of the present study were to describe the patterns of parenchymal lesions associated with CVT and to determine the lesion sites.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| hemorrhagic ischemia | – | Other: radiological comparisoncomparison between clinical characteristics and the confirmed diagnosis by RMI (magnetic resonance Imaging) |
| nonhemorrhagic ischemia | – | Other: radiological comparisoncomparison between clinical characteristics and the confirmed diagnosis by RMI (magnetic resonance Imaging) |
| intracerebral hematoma | – | Other: radiological comparisoncomparison between clinical characteristics and the confirmed diagnosis by RMI (magnetic resonance Imaging) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The investigators want to include consecutively hospitalized patients with CVT and parenchymal lesions on magnetic resonance imaging.
Key inclusion criteria (2 listed)
- hospitalized patients with CVT
- parenchymal lesions on magnetic resonance imaging
Key exclusion criteria (1 listed)
- No CVT
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 |
|---|---|---|
| radiological comparisoncomparison between clinical and radiological characteristics | Other | hemorrhagic ischemia, intracerebral hematoma, nonhemorrhagic ischemia |
Primary outcome
patterns
Time frame: 0
describe the patterns of parenchymal lesions associated with CVT and to determine the lesion sites.
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 2 Aug 2018.
- 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.
Audrey Arnoux, MD principal investigator
CHU Amiens
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Superior Sagittal Sinus Thrombosis, run by Centre Hospitalier Universitaire, Amiens at 2 sites 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 2 inclusion and 1 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 2 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
patterns (time frame: 0). 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 2 Aug 2018.