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NCT Number: NCT06451887

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

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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, 310014, China

Location status: Recruiting

Location contact

Huiyuan Wang

SUB_INVESTIGATOR

Sheng Zhang

CONTACT

[email protected]

+8618758188313

Sheng Zhang

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 CT perfusion scan before treatment; (5)Confirmation of internal carotid artery (ICA) or middle cerebral artery (MCA) occlusion or tandem occlusion by Digital Subtraction Angiography (DSA) and subsequent EVT; (6)complete 3-months follow-up.

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. The occurrence of MBE

    Time frame: 3 days post-EVT

    Patients developed MBE within 3 days post-EVT

Secondary outcomes

  1. 90 days mRS score

    Time frame: 90 days after EVT

    The follow-up mRS scores of enrolled patients at 90 days after EVT.

  2. PH

    Time frame: 3-5 days after EVT

    Evidence of parenchymal hemorrhage (PH type) on cranial imaging at 3-5 days after EVT

Study contacts

Contact information is provided by the study sponsor or research team.

Sheng Zhang

CONTACT

[email protected]

18758188313

Sponsors and collaborators

Lead sponsor

Zhejiang Provincial People's Hospital

Other

Registry information

Acronym: EMBRACE

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jun 11, 2024
Registry last updated
Jun 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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