Early Identification of Malignant Brain Edema in laRge Artery oCclusive Stroke After Endovascular Therapy (EMBRACE Study)

Last updated: June 6, 2024
Sponsor: Zhejiang Provincial People's Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stroke

Thrombosis

Blood Clots

Treatment

N/A

Clinical Study ID

NCT06451887
KY2024058
  • Ages 18-80
  • All Genders

Study Summary

To design and validate a predictive model for malignant brain edema after endovascular thrombectomy.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • (1)Age > 18 years old; (2)Onset of stroke to hospital admission < 24 hours; (3)Admission with a head CT scan ruling out hemorrhage; (4)Patients undergoing CTperfusion scan before treatment; (5)Confirmation of internal carotid artery (ICA) ormiddle cerebral artery (MCA) occlusion or tandem occlusion by Digital SubtractionAngiography (DSA) and subsequent EVT; (6)complete 3-months follow-up.

Exclusion

Exclusion Criteria:

  • (1)Poor quality of preoperative CT perfusion imaging; (2)Posterior circulationocclusion or isolated anterior cerebral artery occlusion; (3)Presence of othersevere diseases such as malignant tumors, severe organ failure, or otherlife-threatening conditions with an expected survival period of less than 90 days; (4)Incomplete imaging and clinical data.

Study Design

Total Participants: 1950
Study Start date:
April 01, 2024
Estimated Completion Date:
June 30, 2027

Study Description

Stroke is a significant global cause of death and disability. Endovascular thrombectomy (EVT) is currently the best treatment for acute large vessel occlusion stroke (ALVOS), as it can greatly reduce mortality and improve patient outcomes. However, only half of patients who undergo EVT achieve functional independence, and malignant brain edema (MBE), a severe complication, can occur after the procedure, leading to a poor prognosis. Previous studies have confirmed the effectiveness of early decompressive hemicraniectomy in reducing morbidity and mortality in patients with malignant brain edema. Therefore, identifying high-risk patients for MBE can help clinicians make appropriate triage and early intervention decisions, potentially saving patients' lives.

Predictive factors for post-ischemic stroke brain edema have been widely discussed, and reliable early predictive indicators have been identified, such as age, early consciousness disorders, baseline National Institutes of Health Stroke Scale (NIHSS), atrial fibrillation, hypertension, baseline blood glucose, and the level of reperfusion after EVT. Radiological factors, such as the Alberta Stroke Program Early CT Score (ASPECTS), collateral circulation rating of arteries, venous outflow status, CT perfusion core infarct volume, perfusion-based collateral status, and clot burden, are closely associated with the occurrence of MBE post-EVT. However, due to individual differences and multiple factors affecting MBE, a single factor cannot effectively predict MBE. Establishing a clinical risk prediction model can effectively identify high-risk populations for MBE at an early stage.

Connect with a study center

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang 310014
    China

    Active - Recruiting

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