Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06451887
Status:
RECRUITING
Last Update Posted:
2024-06-11
First Post:
2024-05-27
Brief Title:
Early Identification of Malignant Brain Edema in laRge Artery oCclusive Stroke After Endovascular Therapy EMBRACE Study
Sponsor:
Zhejiang Provincial Peoples Hospital
Organization:
Zhejiang Provincial Peoples Hospital
Study Overview
Official Title:
Early Identification of Malignant Brain Edema in laRge Artery oCclusive Stroke After Endovascular Therapy EMBRACE Study
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EMBRACE
Brief Summary:
To design and validate a predictive model for malignant brain edema after endovascular thrombectomy
Detailed 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None