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

NCT06361017 | Enrolling By Invitation DMC

• 1 other identifier: QNPY2022007
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Ischemic Stroke; Endovascular Thrombectomy; Dynamic Cerebral Autoregulation

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• The occurrence of long-term unfavorable outcome

  1 year

• The occurrence of long-term favorable outcome

  1 year

Study Arms (4)

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

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

HT group

HT group was defined as the AIS patients have hemorrhage transformation in 7 days after endovascular thrombectomy.

Procedure: endovascular 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

Interventions

endovascular thrombectomy PROCEDURE

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.

Also known as: mechanical thrombectomy

HT group; favorable outcome group; non-HT group; unfavorable outcome group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Department of Vascular Ultrasonography, Xuanwu Hospital of Capital Medical University

Beijing, Beijing Municipality, 100053, China

Location

Related Publications (3)

• 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.

  PMID: 32414382 BACKGROUND

• 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.

  PMID: 29129157 BACKGROUND

• 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.

  PMID: 35707901 RESULT

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Yingqi Xing, M.D.

  Department of Vascular Ultrasonography, Xuanwu Hospital.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2024
• First Posted: April 11, 2024
• Study Start: March 1, 2022
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2026
• Last Updated: August 6, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)