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

• Conditions: Endovascular Thrombectomy; Acute Ischemic Stroke; Dynamic Cerebral Autoregulation
• Interventions: Procedure: endovascular thrombectomy

• Registration Number: NCT06361017
• Lead Sponsor: Xuanwu Hospital, Beijing

Brief 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.

Study Timeline

• Study Start: 2022-03-01
• Study First Submitted: 2024-03-26
• Status Verified: 2024-04
• Study First Submitted QC: 2024-04-08
• Study First Posted: 2024-04-11
• Last Update Submitted: 2024-08-04
• Last Update Posted: 2024-08-06
• Primary Completion: 2025-03-01
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• (i) age ≥18 years; (ii) complete recanalization of the affected MCA (thrombolysis in cerebral infarction grade 2b or 3); and (iii) sufficient temporal windows to obtain flow signals for the MCA.

Exclusion Criteria

• (i) inability to perform dCA after EVT due to restlessness; (ii) re-occlusion of the culprit MCA after EVT; and (iii) other conditions such as low cerebral blood flow caused by severe heart disease.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
non-HT group	endovascular thrombectomy	Non-HT group was defined as the AIS patients do not have hemorrhage transformation in 7 days after endovascular thrombectomy.
HT group	endovascular thrombectomy	HT group was defined as the AIS patients have hemorrhage transformation in 7 days after endovascular thrombectomy.
favorable outcome group	endovascular thrombectomy	The favorable outcome group was defined as the modified Rankin Scale (mRS) score ≤2 in the AIS patients at 3 months after endovascular thrombectomy.
unfavorable outcome group	endovascular thrombectomy	The unfavorable outcome group was defined as the modified Rankin Scale (mRS) score with 3-6 in the AIS patients at 3 months after endovascular thrombectomy.

Primary Outcome Measures

Name	Time	Method
The occurrence of unfavorable outcome	3 months	The modified Rankin Scale (mRS) score was 3-6 of AIS patients with EVT after 3 months.
The occurrence of favorable outcome	3 months	The modified Rankin Scale (mRS) score ≤2 of AIS patients with EVT after 3 months.
The occurrence of hemorrhage transformation	7 days	The AIS patients have hemorrhage transformation detected by head computed tomography scans within 7 days after EVT
Patients without hemorrhage transformation	7 days	The AIS patients do not have hemorrhage transformation detected by head computed tomography scans within 7 days after EVT

Secondary Outcome Measures

Name	Time	Method
The occurrence of long-term unfavorable outcome	1 year	The modified Rankin Scale (mRS) score was 3-6 of AIS patients with EVT after 1 year.
The occurrence of long-term favorable outcome	1 year	The modified Rankin Scale (mRS) score ≤2 of AIS patients with EVT after 1 year.

Trial Locations

Locations (1)

Department of Vascular Ultrasonography, Xuanwu Hospital of Capital Medical University; 🇨🇳 Beijing, Beijing, China