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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06361017

Acronym

PHASE

Enrollment

300

Registered

2024-04-11

Start date

2022-03-01

Completion date

2026-03-01

Last updated

2024-08-06

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

Conditions

Acute Ischemic Stroke, Dynamic Cerebral Autoregulation, Endovascular Thrombectomy

Keywords

Acute Ischemic Stroke, ultrasound, endovascular thrombectomy, dynamic cerebral autoregulation, Hemodynamics

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.

Interventions

PROCEDUREendovascular 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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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
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.

Secondary

Measure	Time frame	Description
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.

Countries

China

Outcome results

None listed

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