StrokeVASTNCT03838289
Study of Cerebral Venous System in Acute Ischemic Stroke Patients Receiving Reperfusion Therapy
An observational study of Stroke and Cerebral Venous System, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
The VAST study is a single-center prospective observational study that enrolled individuals with acute ischemic stroke (AIS) within 24 hours onset. The patients will receive neurological examination, multimodal computed tomographic perfusion (CTP) or multimodal magnetic resonance perfusion (MRP) before reperfusion… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Cerebral Venous System, Reperfusion Injury
- What is being tested?
- multimodal magnetic resonance imaging or computed tomography
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2020to 31 Dec 2025
- 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: acute ischemic stroke patients
Who may be able to join
- receive reperfusion therapy within 24 hours after onset;
- undergo multimodal magnetic resonance computed tomography before reperfusion therapy and CTP or magnetic resonance perfusion at 24 hours after reperfusion therapy;
Who cannot join
- Contraindication to imaging with contrast agents;
- Without provision of informed consent.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The second affiliated hosipital of Zhejiang University
Hangzhou, Zhejiang
Min Lou, Ph.D, 13958007213, loumingxc@vip.sina.com
About this study
Official title: Study of the Function of Cerebral Venous System in Acute Ischemic Stroke Patients Receiving Reperfusion Therapy
The VAST study is a single-center prospective observational study that enrolled individuals with acute ischemic stroke (AIS) within 24 hours onset. The patients will receive neurological examination, multimodal computed tomographic perfusion (CTP) or multimodal magnetic resonance perfusion (MRP) before reperfusion therapy. The hypoperfusion volume, ischemic core volume, brain edema, cerebral arterial collaterals will be evaluated on baseline brain image. The status of cerebral venous system (CVs) including superficial middle cerebral vein, vein of Labbe, vein of Trolard, Sphenoid sinus, thalamostriate vein, Internal cerebral vein, Rosenthal's vein will be evaluated in phases of reconstructed imaging from CTP/MRP. The investigators will explore the venous markers for prognosis of AIS patients who received reperfusion therapy, and find the role of venous system in reperfusion injury.
Read the detailed description
Stroke therapy had entered a new era since endovascular therapy was introduced in addition to intravenous thrombolysis. The benefit of endovascular therapy for patients with a proven proximal intracranial arterial occlusion has recently been revealed in several large randomized controlled trials. However, a substantial number of patients treated with reperfusion therapy did not reach functional independence in long-term follow-up, despite relatively high recanalization rates. Therefore, simple and more reliable markers that identify patients most likely to benefit from reperfusion therapy are needed. Accumulated studies showed that arterial status such as arterial collaterals had been considered as a critical predictor of outcome or determinant criteria for therapeutic selection. However, other evidences denied that arterial collaterals serve as a predictors for outcome after recanalization. Moreover, non-reflow phenomenon, over-reperfusion and futile recanalization may lead to large infarct, brain swelling, hemorrhagic complication and neurological deterioration. The traditional pathophysiological understanding on ischemic stroke can hardly explain these occurrences. Recently, the importance of cerebral venous drainage, the major blood reservoir and drainage system in brain, has been described for stroke evolution and clinical sequelae. In this study, the aim is to investigate the roles of cerebral venous dynamic status on neurological outcome after reperfusion therapy and the potential mechanisms behind poor veins and adverse outcome. In this study, the investigators will prospectively recruit the AIS patients over 18 years old who undergo baseline CTP/MRP and receive reperfusion therapy within 24 hour after onset. Each of their perfusion imaging will be reconstructed to evaluate the status of cerebral vein system. The investigators hypothesized that the venous dynamic status may have effect on the ischemic-reperfusion progress, and may thus has the potential to impact the stroke outcome. This study may add new implications for stroke outcome prediction and future therapeutic decision-making.
- Conditions
- Stroke, Cerebral Venous System, Reperfusion Injury
- Being tested
- multimodal magnetic resonance imaging or computed tomography
- Medical subject headings
- Stroke, Reperfusion Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multimodal magnetic resonance imaging or computed tomographyRadiation
Also called blood samples collection, neurological examination
multimodal magnetic resonance imaging including T1 Flair,T2 Flair, magnetic resonance angiography (MRA), perfusion-weighted imaging (PWI), diffusion-weighted imaging (DWI), enhanced gradient echo T2 star weighted angiography (ESWAN); multimodal computed tomography including non-contrast CT, volume perfusion CT
| Study group | Role | What they receive |
|---|---|---|
| Individuals with absent filling of CVs | Individuals with absent filling of following CVs: superficial middle cerebral vein, vein of Labbe, vein of Trolard, Sphenoid sinus, thalamostriate vein, Internal cerebral vein, Rosenthal's vein Receives: Radiation: multimodal magnetic resonance imaging or computed tomography | |
| individuals without any absent filling of CVs | Individuals without any absent filling of following CVs: superficial middle cerebral vein, vein of Labbe, vein of Trolard, Sphenoid sinus, thalamostriate vein, Internal cerebral vein, Rosenthal's vein Receives: Radiation: multimodal magnetic resonance imaging or computed tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prognosis
modified Rankin Scale at 90 days:
- 0 = No symptoms;
- 1 = No significant disability. Able to carry out all usual activities, despite some symptoms;
- 2 = Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities;
- 3 = Moderate disability. Requires some help, but able to walk unassisted;
- 4 = Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted;
- 5 = Severe disability. Requires constant nursing care and attention, bedridden, incontinent;
- 6 = Dead.
A score of >2 means poor outcome.
Measured: 90 days
Secondary outcomes (2)
Brain edema
brain edema scale at 24-hour after reperfusion therapy:
- 0 = indicates no swelling;
- 1 = effacement of cortical sulci;
- 2 = 1+minor effacement of the ipsilateral lateral ventricle;
- 3 = 1+complete effacement of the ipsilateral lateral ventricle;
- 4 = 3+effacement of the third ventricle;
- 5 = shift of the midline away from the side of the infarction;
- 6 = 5+effacement of basal cisterns.
Measured: 24-hour
Hemorrhage transformation
hemorrhage transformation at 24-hour after reperfusion therapy:
- Hemorrhagic infarction 1 (HI1) was defined as small petechiae along the margins of the infarct;
- Hemorrhagic infarction 2 (HI2) as confluent petechiae within the infarcted area but no space-occupying effect;
- Parenchymal hemorrhage (PH1) as blood clots in 30% or less of the infarcted area with some slight space-occupying effect; and
- Parenchymal hemorrhage (PH2) as blood clots in more than 30% of the infarcted area with substantial space-occupying effect.
- Symptomatic intracranial hemorrhage was defined as blood at any site in the brain on the CT scan.
Measured: 24-hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2019
- Study start1 Mar 2020
- Primary completionDec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
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 Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- 300 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03838289
- Sponsor's protocol ID
- cerebral vein
- Acronym
- VAST
- Status last verified
- Apr 2023
- First submitted
- 28 Jan 2019
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Function of Cerebral Venous System in Acute Ischemic Stroke Patients Receiving Reperfusion Therapy
- ClinicalTrials.gov ID
- NCT03838289
- Acronym / sponsor ID
- VAST / cerebral vein
- Conditions
- Stroke, Cerebral Venous System, Reperfusion Injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 12 Feb 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.
The VAST study is a single-center prospective observational study that enrolled individuals with acute ischemic stroke (AIS) within 24 hours onset. The patients will receive neurological examination, multimodal computed tomographic perfusion (CTP) or multimodal magnetic resonance perfusion (MRP) before reperfusion therapy. The hypoperfusion volume, ischemic core volume, brain edema, cerebral arterial collaterals will be evaluated on baseline brain image. The status of cerebral venous system (CVs) including superficial middle cerebral vein, vein of Labbe, vein of Trolard, Sphenoid sinus, thalamostriate vein, Internal cerebral vein, Rosenthal's vein will be evaluated in phases of reconstructed imaging from CTP/MRP. The investigators will explore the venous markers for prognosis of AIS patients who received reperfusion therapy, and find the role of venous system in reperfusion injury.
Detailed description
Stroke therapy had entered a new era since endovascular therapy was introduced in addition to intravenous thrombolysis. The benefit of endovascular therapy for patients with a proven proximal intracranial arterial occlusion has recently been revealed in several large randomized controlled trials. However, a substantial number of patients treated with reperfusion therapy did not reach functional independence in long-term follow-up, despite relatively high recanalization rates. Therefore, simple and more reliable markers that identify patients most likely to benefit from reperfusion therapy are needed. Accumulated studies showed that arterial status such as arterial collaterals had been considered as a critical predictor of outcome or determinant criteria for therapeutic selection. However, other evidences denied that arterial collaterals serve as a predictors for outcome after recanalization. Moreover, non-reflow phenomenon, over-reperfusion and futile recanalization may lead to large infarct, brain swelling, hemorrhagic complication and neurological deterioration. The traditional pathophysiological understanding on ischemic stroke can hardly explain these occurrences. Recently, the importance of cerebral venous drainage, the major blood reservoir and drainage system in brain, has been described for stroke evolution and clinical sequelae. In this study, the aim is to investigate the roles of cerebral venous dynamic status on neurological outcome after reperfusion therapy and the potential mechanisms behind poor veins and adverse outcome. In this study, the investigators will prospectively recruit the AIS patients over 18 years old who undergo baseline CTP/MRP and receive reperfusion therapy within 24 hour after onset. Each of their perfusion imaging will be reconstructed to evaluate the status of cerebral vein system. The investigators hypothesized that the venous dynamic status may have effect on the ischemic-reperfusion progress, and may thus has the potential to impact the stroke outcome. This study may add new implications for stroke outcome prediction and future therapeutic decision-making.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individuals with absent filling of CVs | – | Radiation: multimodal magnetic resonance imaging or computed tomographyIndividuals with absent filling of following CVs: superficial middle cerebral vein, vein of Labbe, vein of Trolard, Sphenoid sinus, thalamostriate vein, Internal cerebral vein, Rosenthal's vein |
| individuals without any absent filling of CVs | – | Radiation: multimodal magnetic resonance imaging or computed tomographyIndividuals without any absent filling of following CVs: superficial middle cerebral vein, vein of Labbe, vein of Trolard, Sphenoid sinus, thalamostriate vein, Internal cerebral vein, Rosenthal's vein |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- acute ischemic stroke patients
Key inclusion criteria (2 listed)
- receive reperfusion therapy within 24 hours after onset;
- undergo multimodal magnetic resonance computed tomography before reperfusion therapy and CTP or magnetic resonance perfusion at 24 hours after reperfusion therapy;
Key exclusion criteria (2 listed)
- Contraindication to imaging with contrast agents;
- Without provision of informed consent.
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 |
|---|---|---|
| multimodal magnetic resonance imaging or computed tomographyAlso: blood samples collection, neurological examinationmultimodal magnetic resonance imaging including T1 Flair,T2 Flair, magnetic resonance angiography (MRA), perfusion-weighted imaging (PWI), diffusion-weighted imaging (DWI), enhanced gradient echo T2 star weighted angiography (ESWAN); multimodal computed tomography including non-contrast CT, volume perfusion CT | Radiation | Individuals with absent filling of CVs, individuals without any absent filling of CVs |
Primary outcome
Prognosis
Time frame: 90 days
modified Rankin Scale at 90 days: * 0 = No symptoms; * 1 = No significant disability. Able to carry out all usual activities, despite some symptoms; * 2 = Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities; * 3 = Moderate disability. Requires some help, but able to walk unassisted; * 4 = Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted; * 5 = Severe disability. Requires constant nursing care and attention, bedridden, incontinent; * 6 = Dead. A score of >2 means poor outcome.
2 secondary outcomes
Brain edema
Time frame: 24-hour
Hemorrhage transformation
Time frame: 24-hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Individual participant dataSharing planned: Undecided
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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.
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 Stroke and Cerebral Venous System, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 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: status not confirmed, as of the sponsor's last update on 18 Apr 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?
Contact Min Lou, Ph.D (13958007213, loumingxc@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prognosis (time frame: 90 days). 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 18 Apr 2023.