Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To design and validate a predictive model for malignant brain edema after endovascular thrombectomy.
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.
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| The occurrence of MBE | Patients developed MBE within 3 days post-EVT | 3 days post-EVT |
| Measure | Description | Time Frame |
|---|---|---|
| 90 days mRS score | The follow-up mRS scores of enrolled patients at 90 days after EVT. | 90 days after EVT |
| PH | Evidence of parenchymal hemorrhage (PH type) on cranial imaging at 3-5 days after EVT |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
The study is a multicenter, prospective, observational clinical registry study, commenced on April 1, 2024, and is expected to end in June 2027. Participants were ALVOS patients undergoing EVT treatment in neurology departments from multiple stroke centers. The data from Zhejiang Provincial People's Hospital compose the model training cohort, while data from other centers serve as an independent external validation cohort. The protocol of the study has been approved by the human Ethics Committee of Zhejiang Provincial People's Hospital (KY2024058). All clinical investigations will be conducted according to the principles set in the Declaration of the Helsinki.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sheng Zhang | Contact | 18758188313 | zhangsheng@hmc.edu.cn |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang Provincial People's Hospital | Recruiting | Hangzhou | Zhejiang | 310014 | China |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 20, 2024 | Jun 6, 2024 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 20, 2024 | Jun 6, 2024 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D001929 | Brain Edema |
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020521 | Stroke |
Not provided
Not provided
Not provided
Not provided
Not provided
| 3-5 days after EVT |
| D002561 |
| Cerebrovascular Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |