NCT06361017

The Prediction of Hemorrhage Transformation by Cerebral Autoregulation in AIS Patient After Endovascular Thrombectomy

Research of the Prediction of Hemorrhage Transformation and Clinical Outcome by Cerebral Autoregulation After Endovascular Thrombectomy in Acute Ischemic Stroke Patients Caused by Middle Cerebral Artery or Internal Carotid Artery Occlusion.

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Xuanwu Hospital, Beijing · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This observational study was designed for observe the cerebral hemodynamics and dynamic cerebral autoregulation (dCA) after endovascular thrombectomy (EVT) in acute ischemic stroke (AIS) patients. And analysis the relationship between the dCA damage degree and hemorrhage transformation (HT) and clinical outcome. Patients: patients with AIS caused by middle cerebral artery or internal carotid artery occlusion who accepted EVT. dCA Examination: dCA examinations were performed at 24 hours, 48 hours, 72 hours, and 5 days after EVT. The objectives of the study were as follows: The changes of cerebral hemodynamics and parameters of dCA in different time periods after EVT were analyzed. So as to determine the correlation between hemodynamics and dCA change and HT and clinical outcome after EVT and to explore the predictors of HT and adverse clinical outcomes.

Detailed description

Part of the data from March 2022 to March 2022 was obtained, but it was still need more data and need a one-year follow-up of the data. Therefore, this is a 4 years prospective cohort study. The objectives of the study were as follows: This observational study was designed for observe the cerebral hemodynamics and dynamic cerebral autoregulation (dCA) after endovascular thrombectomy (EVT) in acute ischemic stroke (AIS) patients. And analysis the relationship between the dCA damage degree and hemorrhage transformation (HT) and clinical outcomes. To explore the predictors of HT and adverse clinical outcomes. A. To enroll 300 cases of patients with AIS caused by middle cerebral artery or internal carotid artery occlusion who accepted EVT. B. dCA examinations were performed at 24 hours, 48 hours, 72 hours, and 5 days after EVT. C. The computed tomography was performed to distinguish if the patients have HT within 7 days after EVT. D. Utilizing the modified Rankin Scale (mRS), the clinical prognosis was assessed 3 months and 1 year after stroke. The outcomes were dichotomized according to the mRS score: favorable outcome (mRS ≤ 2) and unfavorable outcome (mRS: 3-6). During the telephone call follow-up, the clinician was unaware of any pertinent clinical or dCA information while examining each mRS score. E. All tests are non-invasive.

Conditions

• Acute Ischemic Stroke
• Endovascular Thrombectomy
• Dynamic Cerebral Autoregulation

Interventions

Type	Name	Description
PROCEDURE	endovascular thrombectomy	All individuals were anesthetized, with local or general anesthesia dependent on the cooperation level of the patient. During the procedure, it was mandatory to administer intravenous heparin to maintain the activated clotting time between 250 and 300 s, except for subjects who received intravenous alteplase. The procedures were performed through the femoral artery. The selection of stent retriever type and size, along with any required devices, such as guide wires and catheters, as well as the intervention strategy, was at the interventionists' discretion.

Timeline

• Start date: 2022-03-01
• Primary completion: 2025-03-01
• Completion: 2026-03-01
• First posted: 2024-04-11
• Last updated: 2024-08-06

Locations

1 site across 1 country: China