Cerebral Venous Sinus ThrombosisNCT03273179
Cerebral Venous Sinus Thrombosis: Re-exploration of Clinical Assessment Scales
An observational study of Cerebral Venous Sinus Thrombosis and CSF Pressure Increased, run by Capital Medical University at 1 site in China.
Trial summary
This is a single-center, retrospective, open-label study. This study is planned to investigate the accuracy of mRS and NIHSS, comparing with the accuracy of CSF pressure and papilledema grade in assessing cerebral venous sinus thrombosis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cerebral Venous Sinus Thrombosis, CSF Pressure Increased, Papilledema
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2017to 1 Jul 2018
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: All individual with confirmed diagnosis of CVST are eligible for this research
Who may be able to join
- confirmed diagnosis of CVST by head MRI, DSA or MRV onset of CVST within one month
Who cannot join
- unable to complete examinations unable to complete follow-ups
Trial locations and contacts
1 site in 1 country.
Zhen Zhang contact
China1 site, 1 recruiting
- Recruiting
Xuanwu Hospital Capital Medical University
Beijing
Zhang Zhen, gzhenzhang@sina.com
About this study
Official title: Cerebral Venous Sinus Thrombosis: Re-exploration of Clinical Assessment
This is a single-center, retrospective, open-label study. This study is planned to investigate the accuracy of mRS and NIHSS, comparing with the accuracy of CSF pressure and papilledema grade in assessing cerebral venous sinus thrombosis.
- Keywords
- cerebral venous sinus thrombosis, CSF pressure, modified Rankin Scale, papilledema, NIHSS
- Medical subject headings
- Intracranial Hypertension, Papilledema
What is being measured
The primary outcome is the main question the study is designed to answer.
baseline CSF pressure
CSF pressure at baseline
Measured: baseline
baseline mRS
mRS at baseline
Measured: baseline
baseline papilledema grade
Frisen grade of papilledema at baseline
Measured: baseline
Secondary outcomes (1)
baseline NIHSS
NIH Stroke Scale at baseline
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2017
- Study start1 Jun 2017
- Primary completion1 Apr 2018 (estimated)
- Study completion1 Jul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Venous Sinus ThrombosisStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Xunming, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03273179
- Sponsor's protocol ID
- CVST-RCAS
- Status last verified
- Feb 2018
- First submitted
- 3 Sep 2017
- Last updated
- 5 Feb 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Venous Sinus Thrombosis: Re-exploration of Clinical Assessment
- ClinicalTrials.gov ID
- NCT03273179
- Acronym / sponsor ID
- CVST-RCAS
- Keywords
- cerebral venous sinus thrombosis, CSF pressure, modified Rankin Scale, papilledema, NIHSS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 1 Apr 2018 (estimated)
- Study completion
- 1 Jul 2018 (estimated)
- First posted
- 6 Sep 2017 (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.
This is a single-center, retrospective, open-label study. This study is planned to investigate the accuracy of mRS and NIHSS, comparing with the accuracy of CSF pressure and papilledema grade in assessing cerebral venous sinus thrombosis.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- All individual with confirmed diagnosis of CVST are eligible for this research
Key inclusion criteria (1 listed)
- confirmed diagnosis of CVST by head MRI, DSA or MRV onset of CVST within one month
Key exclusion criteria (1 listed)
- unable to complete examinations unable to complete follow-ups
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
baseline CSF pressure
Time frame: baseline
CSF pressure at baseline
baseline mRS
Time frame: baseline
mRS at baseline
baseline papilledema grade
Time frame: baseline
Frisen grade of papilledema at baseline
1 secondary outcome
baseline NIHSS
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 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.
Zhen Zhang contact
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 Venous Sinus Thrombosis and CSF Pressure Increased, run by Capital Medical University at 1 site in China.
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 1 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: status not confirmed, as of the sponsor's last update on 5 Feb 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 China. 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 Xunming Ji (+86-83198952, jixunming@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
baseline CSF pressure (time frame: baseline). The study lists 3 primary outcomes in all. 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 5 Feb 2018.