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UnknownNCT03838289

Study of Cerebral Venous System in Acute Ischemic Stroke Patients Receiving Reperfusion Therapy

Study of the Function of Cerebral Venous System in Acute Ischemic Stroke Patients Receiving Reperfusion Therapy

Status
Unknown
Phase
Study type
Observational
Enrollment
300 (estimated)
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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 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.

Conditions

Interventions

TypeNameDescription
RADIATIONmultimodal magnetic resonance imaging or computed tomographymultimodal 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

Timeline

Start date
2020-03-01
Primary completion
2024-12-01
Completion
2025-12-31
First posted
2019-02-12
Last updated
2023-04-18

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT03838289. Inclusion in this directory is not an endorsement.