Acute Ischemic StrokeNCT05228080
Predictive Study of Serum Endocan for Hemorrhagic Transformation After Reperfusion Therapies in Acute Ischemic Stroke
An observational study of Acute Ischemic Stroke, run by Xijing Hospital at 1 site in China.
Trial summary
Stroke is the second largest cause of death globally after ischemic heart disease.Of the total number of prevalent strokes, 84.4% are ischemic. Reperfusion therapy is the most important treatment for acute ischemic stroke (AIS) ,including intravenous thrombolysis and/or endovascular treatment.However,the most serious… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- enzyme-linked immunosorbent assay(ELISA)
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2021to 1 Feb 2023
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The patients in Xijing Hospital,Yan 'an University Xianyang Hospital and Xianyang First People's Hospital
Who may be able to join
- Clinical diagnosis of acute ischemic stroke and presentation at the hospital within 24h from symptom onset
- Eligibility for intravenous thrombolysis and/or endovascular treatment
- Age ≥18 years
Who cannot join
- Administration of intravenous thrombolysis at another hospital in patients who are candidates for endovascular treatment
- Contraindications to intravenous thrombolysis
- Contraindications to iodinated contrast agent
- A history of ischemic stroke in three months
- Clinical diagnosis of autoimmune,inflammatory, hematological, or infectious diseases
- Clinical diagnosis of cancer
Show all 9Show fewer
- Clinical diagnosis of severe cardiac,pulmonary,renal or liver failure
- Clinical diagnosis of dementia or psychosis
- Pregnant and lactating women
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xijing Hospital
Xi'an, Shaanxi, 710032
JIA-NING WU, 15353390103, wjn19961230@yeah.net
About this study
Stroke is the second largest cause of death globally after ischemic heart disease.Of the total number of prevalent strokes, 84.4% are ischemic. Reperfusion therapy is the most important treatment for acute ischemic stroke (AIS) ,including intravenous thrombolysis and/or endovascular treatment.However,the most serious and common complication with reperfusion therapy is hemorrhage transformation(HT),which significantly increases disability and mortality. The fundamental mechanism leading to post-stroke HT is the disruption of the blood brain barrier(BBB) and increase of permeability.Endocan plays a critical role in vascular inflammatory responses by enhances the production of pro-inflammatory cytokines by endothelial cells,the expression of adhesion molecules such as inter-cellular adhesion molecule-1(ICAM-1) and vascular cell adhesion molecule-1(VCAM-1),and the adhesion of leukocytes to endothelial cells. Endocan significantly decreases levels of zonula occludens（ZO-1) and occludin which are tight junction proteins that play major roles in the maintenance of vascular barriers. Endocan could induce vascular endothelial growth factor-A(VEGF-A) and facilitate the binding of VEGF-A to its receptor(VEGFR-2) to enhanced endothelial permeability.Therefore,endocan is a reliable biomarker of endothelial dysfunction, which may be associated with disruption of the BBB. In this context, the investigators hypothesized that elevated pretreatment serum endocan levels might be independently associated with HT after reperfusion therapy in the acute phase of ischemic stroke. Serum endocan,ICAM-1,VCAM-1 and matrix metalloproteinase-9(MMP-9) levels will be determined by enzyme-linked immunosorbent assay(ELISA) in blood samples obtained at baseline (pretreatment) and at 12,24 hours after reperfusion therapy in patients with acute stroke and in healthy subjects.In the present study,the investigators attempt to investigate whether high levels of endocan are associated with HT in patients who received reperfusion therapy.In addition,the investigators explore the association between serum endocan and early neurological deterioration and unfavourable short-term prognosis.
- Conditions
- Acute Ischemic Stroke
- Being tested
- enzyme-linked immunosorbent assay(ELISA)
- Keywords
- endocan, stroke, reperfusion, hemorrhage
- Medical subject headings
- Ischemic Stroke, Stroke, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enzyme-linked immunosorbent assay(ELISA)Diagnostic test
Peripheral blood samples will be drawn from each patient at study entry (before reperfusion therapy) and at 12,24 hours after reperfusion therapy.Serum will be immediately separated by centrifugation at 3000 rpm for 15 minutes and stored at -80°C. Endocan,ICAM-1,VCAM-1,MMP-9 levels will be determined in duplicate by commercially available enzyme-linked immunosorbent assay (ELISA).
| Study group | Role | What they receive |
|---|---|---|
| acute ischemic stroke | Not described Receives: Diagnostic Test: enzyme-linked immunosorbent assay(ELISA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Hemorrhagic Transformation after reperfusion therapy
Patients will undergo the cranial CT at 24 to 48 hours after reperfusion therapy to identify intracranial hemorrhage
Measured: At 24 to 48 hours after reperfusion therapy
Secondary outcomes (2)
Incidence of early neurological deterioration
Either death or an increase in the NIHSS score by ≥4 points from baseline to 24 hours after reperfusion therapy
Measured: At 24 hours from reperfusion therapy
Incidence of unfavourable short-term prognosis
Death and major disability (modified Rankin Scale score ≥3) at 90 days after stroke onset
Measured: At 90 days after stroke onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start1 Dec 2021
- Primary completion1 Nov 2022 (estimated)
- Study completion1 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05228080
- Sponsor's protocol ID
- KY20212167
- Status last verified
- Nov 2021
- First submitted
- 14 Nov 2021
- Last updated
- 1 Jun 2022
- 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 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Study of Serum Endocan for Hemorrhagic Transformation After Reperfusion Therapies in Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT05228080
- Acronym / sponsor ID
- KY20212167
- Conditions
- Acute Ischemic Stroke
- Keywords
- endocan, stroke, reperfusion, hemorrhage
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Nov 2022 (estimated)
- Study completion
- 1 Feb 2023 (estimated)
- First posted
- 8 Feb 2022 (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.
Stroke is the second largest cause of death globally after ischemic heart disease.Of the total number of prevalent strokes, 84.4% are ischemic. Reperfusion therapy is the most important treatment for acute ischemic stroke (AIS) ,including intravenous thrombolysis and/or endovascular treatment.However,the most serious and common complication with reperfusion therapy is hemorrhage transformation(HT),which significantly increases disability and mortality. The fundamental mechanism leading to post-stroke HT is the disruption of the blood brain barrier(BBB) and increase of permeability.Endocan plays a critical role in vascular inflammatory responses by enhances the production of pro-inflammatory cytokines by endothelial cells,the expression of adhesion molecules such as inter-cellular adhesion molecule-1(ICAM-1) and vascular cell adhesion molecule-1(VCAM-1),and the adhesion of leukocytes to endothelial cells. Endocan significantly decreases levels of zonula occludens（ZO-1) and occludin which are tight junction proteins that play major roles in the maintenance of vascular barriers. Endocan could induce vascular endothelial growth factor-A(VEGF-A) and facilitate the binding of VEGF-A to its receptor(VEGFR-2) to enhanced endothelial permeability.Therefore,endocan is a reliable biomarker of endothelial dysfunction, which may be associated with disruption of the BBB. In this context, the investigators hypothesized that elevated pretreatment serum endocan levels might be independently associated with HT after reperfusion therapy in the acute phase of ischemic stroke. Serum endocan,ICAM-1,VCAM-1 and matrix metalloproteinase-9(MMP-9) levels will be determined by enzyme-linked immunosorbent assay(ELISA) in blood samples obtained at baseline (pretreatment) and at 12,24 hours after reperfusion therapy in patients with acute stroke and in healthy subjects.In the present study,the investigators attempt to investigate whether high levels of endocan are associated with HT in patients who received reperfusion therapy.In addition,the investigators explore the association between serum endocan and early neurological deterioration and unfavourable short-term prognosis.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| acute ischemic stroke | – | Diagnostic Test: enzyme-linked immunosorbent assay(ELISA) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The patients in Xijing Hospital,Yan 'an University Xianyang Hospital and Xianyang First People's Hospital
Key inclusion criteria (3 listed)
- Clinical diagnosis of acute ischemic stroke and presentation at the hospital within 24h from symptom onset
- Eligibility for intravenous thrombolysis and/or endovascular treatment
- Age ≥18 years
Key exclusion criteria (9 listed)
- Administration of intravenous thrombolysis at another hospital in patients who are candidates for endovascular treatment
- Contraindications to intravenous thrombolysis
- Contraindications to iodinated contrast agent
- A history of ischemic stroke in three months
- Clinical diagnosis of autoimmune,inflammatory, hematological, or infectious diseases
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 |
|---|---|---|
| enzyme-linked immunosorbent assay(ELISA)Peripheral blood samples will be drawn from each patient at study entry (before reperfusion therapy) and at 12,24 hours after reperfusion therapy.Serum will be immediately separated by centrifugation at 3000 rpm for 15 minutes and stored at -80°C. Endocan,ICAM-1,VCAM-1,MMP-9 levels will be determined in duplicate by commercially available enzyme-linked immunosorbent assay (ELISA). | Diagnostic test | acute ischemic stroke |
Primary outcome
Incidence of Hemorrhagic Transformation after reperfusion therapy
Time frame: At 24 to 48 hours after reperfusion therapy
Patients will undergo the cranial CT at 24 to 48 hours after reperfusion therapy to identify intracranial hemorrhage
2 secondary outcomes
Incidence of early neurological deterioration
Time frame: At 24 hours from reperfusion therapy
Incidence of unfavourable short-term prognosis
Time frame: At 90 days after stroke onset
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2022.
Related trials for Acute Ischemic Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
RecruitingObservational study
Continuous Dual Aspiration Technique With Zoom System for Stroke
Ischemic Stroke, Acute Stroke
Not yet recruitingPhase 2/3
A Multicenter, Open-label, Randomized, Non-inferiority Clinical Trial With Blinded Endpoint Assessment of Early Tirofiban After Intravenous Thrombolysis in Acute Ischemic Stroke
Acute Ischemic Stroke
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 Acute Ischemic Stroke, run by Xijing Hospital 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 3 inclusion and 9 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 1 Jun 2022. 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 JIA-NING WU (15353390103, wjn19961230@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Hemorrhagic Transformation after reperfusion therapy (time frame: At 24 to 48 hours after reperfusion therapy). 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 1 Jun 2022.