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

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.

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Acute Ischemic Stroke; Dynamic Cerebral Autoregulation; Endovascular Thrombectomy
• Intervention / Treatment: Procedure: endovascular thrombectomy

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 Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100053
      • Department of Vascular Ultrasonography, Xuanwu Hospital of Capital Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Male and female patients 18 years of age and older with acute ischemic stroke who underwent endovascular thrombectomy.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
favorable outcome group; The favorable outcome group was defined as the modified Rankin Scale (mRS) score ≤2 in the AIS patients at 3 months after endovascular thrombectomy.	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.; Other Names: mechanical thrombectomy
unfavorable outcome group; 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.	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.; Other Names: mechanical thrombectomy
HT group; HT group was defined as the AIS patients have hemorrhage transformation in 7 days after endovascular thrombectomy.	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.; Other Names: mechanical thrombectomy
non-HT group; Non-HT group was defined as the AIS patients do not have hemorrhage transformation in 7 days after endovascular thrombectomy.	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.; Other Names: mechanical thrombectomy

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Xuanwu Hospital, Beijing
• Investigators: Principal Investigator: Yingqi Xing, M.D., Department of Vascular Ultrasonography, Xuanwu Hospital.

Publications and helpful links

General Publications

• Nogueira RG, Jadhav AP, Haussen DC, Bonafe A, Budzik RF, Bhuva P, Yavagal DR, Ribo M, Cognard C, Hanel RA, Sila CA, Hassan AE, Millan M, Levy EI, Mitchell P, Chen M, English JD, Shah QA, Silver FL, Pereira VM, Mehta BP, Baxter BW, Abraham MG, Cardona P, Veznedaroglu E, Hellinger FR, Feng L, Kirmani JF, Lopes DK, Jankowitz BT, Frankel MR, Costalat V, Vora NA, Yoo AJ, Malik AM, Furlan AJ, Rubiera M, Aghaebrahim A, Olivot JM, Tekle WG, Shields R, Graves T, Lewis RJ, Smith WS, Liebeskind DS, Saver JL, Jovin TG; DAWN Trial Investigators. Thrombectomy 6 to 24 Hours after Stroke with a Mismatch between Deficit and Infarct. N Engl J Med. 2018 Jan 4;378(1):11-21. doi: 10.1056/NEJMoa1706442. Epub 2017 Nov 11.
• Tian G, Ji Z, Huang K, Lin Z, Pan S, Wu Y. Dynamic cerebral autoregulation is an independent outcome predictor of acute ischemic stroke after endovascular therapy. BMC Neurol. 2020 May 15;20(1):189. doi: 10.1186/s12883-020-01737-w.
• Zhao W, Liu R, Yu W, Wu L, Wu C, Li C, Li S, Chen J, Song H, Hua Y, Ma Q, Ji X. Elevated pulsatility index is associated with poor functional outcome in stroke patients treated with thrombectomy: A retrospective cohort study. CNS Neurosci Ther. 2022 Oct;28(10):1568-1575. doi: 10.1111/cns.13888. Epub 2022 Jun 16.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: March 26, 2024
• First Submitted That Met QC Criteria: April 8, 2024
• First Posted (Actual): April 11, 2024

Study Record Updates

• Last Update Posted (Actual): August 6, 2024
• Last Update Submitted That Met QC Criteria: August 4, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: ultrasound; Hemodynamics; Acute Ischemic Stroke; endovascular thrombectomy; dynamic cerebral autoregulation
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke; Ischemia; Hemorrhage
• Other Study ID Numbers: QNPY2022007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No