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

Acute Ischemic Stroke Clinical Trial

— PHASE  

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.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06361017
• Other study ID #: QNPY2022007
• Status: Enrolling by invitation
• Start date: March 1, 2022
• Est. completion date: March 1, 2026

Study information

• Verified date: April 2023
• Source: Xuanwu Hospital, Beijing
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 300
• Est. completion date: March 1, 2026
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 ?ow 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 ?ow caused by severe heart disease.

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
China	Department of Vascular Ultrasonography, Xuanwu Hospital of Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Xuanwu Hospital, Beijing

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View Citation

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. — View Citation

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;2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The occurrence of hemorrhage transformation	The AIS patients have hemorrhage transformation detected by head computed tomography scans within 7 days after EVT	7 days
Primary	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
Primary	The occurrence of unfavorable outcome	The modified Rankin Scale (mRS) score was 3-6 of AIS patients with EVT after 3 months.	3 months
Primary	The occurrence of favorable outcome	The modified Rankin Scale (mRS) score =2 of AIS patients with EVT after 3 months.	3 months
Secondary	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
Secondary	The occurrence of long-term favorable outcome	The modified Rankin Scale (mRS) score =2 of AIS patients with EVT after 1 year.	1 year