Arterial AneurysmSMCVNCT05714735
SMCV Assessment on Brain Swelling in Patients With SAH From Ruptured Artery Aneurysm
An observational study of Arterial Aneurysm, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
Superficial cerebral veins findings in assessment of brain swelling in patients with aneurysmal subarachnoid hemorrhage who underwent intravenenous DSA examinations Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Arterial Aneurysm
- What is being tested?
- Cerebral Venography
- Type of treatment
- Surgery or procedure
- How many people
- 198 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2017to 30 Dec 2023
- How long will I take part?
- 1 Year
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with anterior circulation aneurysmal subarachnoid hemorrhage
Who may be able to join
- age 18-70 years;
- Hunt-Hess grade IV-V on admission; single aneurysm in the anterior circulation; interventional embolization of aneurysm is the first choice, and preoperative ventricular puncture drainage and intracranial pressure probe placement.
Who cannot join
- Hunt-Hess grade I-III on admission;
- patients with blood bubble-like aneurysm or accompanying intracranial hematoma who are not suitable for interventional embolization; those who directly choose craniotomy and clipping;
- poor general condition or combined with pregnancy , malignant tumors, etc.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Superficial Cerebral Venous Structures in Brain Swelling in Patients With Subarachnoid Hemorrhage From Anterior Communicating Artery Aneurysmal
Superficial cerebral veins findings in assessment of brain swelling in patients with aneurysmal subarachnoid hemorrhage who underwent intravenenous DSA examinations
Read the detailed description
Superficial cerebral veins findings in assessment of brain swelling in patients with aneurysmal subarachnoid hemorrhage who underwent intravenenous DSA examinations.To explore the relationship between the structure of middle and superficial cerebral veins in cerebral angiography and cerebral edema after ischemia-reperfusion of anterior circulation with large core infarction.
- Conditions
- Arterial Aneurysm
- Being tested
- Cerebral Venography
- Keywords
- Brain Swelling,Subarachnoid Hemorrhage,Artery Aneurysmal
- Medical subject headings
- Brain Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cerebral VenographyRadiation
Cerebral Venography Observation by DSA examinations
| Study group | Role | What they receive |
|---|---|---|
| Whole-brain venography | Cerevbral venography Receives: Radiation: Cerebral Venography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
Death
Measured: One year
Bleeding events
Intracerebral Hemorrhage
Measured: One year
Secondary outcomes (1)
Brain swelling
Brain swelling score
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start1 Nov 2017
- Primary completion7 Dec 2019
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arterial AneurysmStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 198 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Collaborators
- The People Hospital of Baoan Shenzhen
- Responsible party
- Sponsor
- Investigators
- qiaoyu huang, M.D, Study director, The People Hospital of Shenzhen Baoan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05714735
- Sponsor's protocol ID
- BAOAN SMCV in SAH
- Acronym
- SMCV
- Status last verified
- Jan 2023
- First submitted
- 27 Jan 2023
- Last updated
- 6 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Superficial Cerebral Venous Structures in Brain Swelling in Patients With Subarachnoid Hemorrhage From Anterior Communicating Artery Aneurysmal
- ClinicalTrials.gov ID
- NCT05714735
- Acronym / sponsor ID
- SMCV / BAOAN SMCV in SAH
- Conditions
- Arterial Aneurysm
- Keywords
- Brain Swelling,Subarachnoid Hemorrhage,Artery Aneurysmal
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Collaborators
- The People Hospital of Baoan Shenzhen
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 7 Dec 2019 (actual)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 6 Feb 2023 (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.
Superficial cerebral veins findings in assessment of brain swelling in patients with aneurysmal subarachnoid hemorrhage who underwent intravenenous DSA examinations
Detailed description
Superficial cerebral veins findings in assessment of brain swelling in patients with aneurysmal subarachnoid hemorrhage who underwent intravenenous DSA examinations.To explore the relationship between the structure of middle and superficial cerebral veins in cerebral angiography and cerebral edema after ischemia-reperfusion of anterior circulation with large core infarction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Whole-brain venography | – | Radiation: Cerebral VenographyCerevbral venography |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with anterior circulation aneurysmal subarachnoid hemorrhage
Key inclusion criteria (2 listed)
- age 18-70 years;
- Hunt-Hess grade IV-V on admission; single aneurysm in the anterior circulation; interventional embolization of aneurysm is the first choice, and preoperative ventricular puncture drainage and intracranial pressure probe placement.
Key exclusion criteria (3 listed)
- Hunt-Hess grade I-III on admission;
- patients with blood bubble-like aneurysm or accompanying intracranial hematoma who are not suitable for interventional embolization; those who directly choose craniotomy and clipping;
- poor general condition or combined with pregnancy , malignant tumors, etc.
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 |
|---|---|---|
| Cerebral VenographyCerebral Venography Observation by DSA examinations | Radiation | Whole-brain venography |
Primary outcome
Death
Time frame: One year
Death
Bleeding events
Time frame: One year
Intracerebral Hemorrhage
1 secondary outcome
Brain swelling
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2023.
Related trials for Arterial Aneurysm
RecruitingObservational study
Determining the Clinical Impact and Prevalence of Hemorrhagic Subtypes in Perimesencephalic Subarachnoid Hemorrhage
Subarachnoid Hemorrhage, Spontaneous, Subarachnoid Hemorrhage, Aneurysmal
Not yet recruitingObservational study
Efficacy of Aflibercept (8 mg) With Sequential Laser Photocoagulation for Macular Edema Secondary to Retinal Artery Macroaneurysm: Retrospective Study"
Retinal Arterial Macroaneurysm
RecruitingObservational study
A Study of Choydar Flow-Directed Mesh Stent in the Treatment of Unruptured Intracranial Aneurysms
Intracranial Aneurysm
Not yet recruiting
Effect of Bilateral Greater Occipital Nerve Block on Headache After Intracranial Aneurysm Coiling
Intracranial Aneurysm, Postoperative Pain
Not yet recruiting
The NUVASCULAR HARBOR Occlusion Device EU Study
Intracranial Arterial Aneurysm
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.
qiaoyu huang, M.D study director
The People Hospital of Shenzhen Baoan
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 Arterial Aneurysm, run by Xuanwu Hospital, Beijing 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 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: status not confirmed, as of the sponsor's last update on 6 Feb 2023. 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?
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?
Death (time frame: One year). The study lists 2 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 6 Feb 2023.