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Predictive Study of Serum Endocan for Hemorrhagic Transformation After Reperfusion Therapies in Acute Ischemic Stroke

Predictive Study of Serum Endocan for Hemorrhagic Transformation After Reperfusion Therapies in Acute Ischemic Stroke

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05228080
Enrollment
100
Registered
2022-02-08
Start date
2021-12-01
Completion date
2023-02-01
Last updated
2022-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Ischemic Stroke

Keywords

endocan, stroke, reperfusion, hemorrhage

Brief 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 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.

Interventions

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).

Sponsors

Xijing Hospital
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* 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 * Clinical diagnosis of severe cardiac,pulmonary,renal or liver failure * Clinical diagnosis of dementia or psychosis * Pregnant and lactating women

Design outcomes

Primary

MeasureTime frameDescription
Incidence of Hemorrhagic Transformation after reperfusion therapyAt 24 to 48 hours after reperfusion therapyPatients will undergo the cranial CT at 24 to 48 hours after reperfusion therapy to identify intracranial hemorrhage

Secondary

MeasureTime frameDescription
Incidence of early neurological deteriorationAt 24 hours from reperfusion therapyEither death or an increase in the NIHSS score by ≥4 points from baseline to 24 hours after reperfusion therapy
Incidence of unfavourable short-term prognosisAt 90 days after stroke onsetDeath and major disability (modified Rankin Scale score ≥3) at 90 days after stroke onset

Countries

China

Contacts

Primary ContactJIA-NING WU
wjn19961230@yeah.net15353390103

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026