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

Acute Ischemic Stroke Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Endovascular Thrombectomy
• Hemorrhage
• Ischemia
• Ischemic Stroke
• Stroke

• NCT number: NCT06361017
• Study type: Observational [Patient Registry]
• Source: Xuanwu Hospital, Beijing
• Status: Enrolling by invitation
• Start date: March 1, 2022
• Completion date: March 1, 2026