Acute Ischemic Stroke, Endovascular Thrombectomy, Malignant Cerebral Edema, Symptomatic Intracranial Hemorrhage
Conditions
Keywords
Acute Ischemic Stroke, Endovascular Thrombectomy, sICH, MCE
Brief summary
To establish a predictive model and scoring system for predicting severe complications after thrombectomy. This scoring system can be used to identify high-risk patients after endovascular thrombectomy, guide the early use of adjunctive interventions, and provide reference for future clinical trials.
Detailed description
Acute ischemic stroke (AIS) accounts for about 80% of all strokes. The focus of AIS treatment is to restore reperfusion of ischemic territory as soon as possible, promote neurological recovery, reduce disability rate and improve long-term survival rate. In recent years, a series of randomized clinical trials have proved that endovascular thrombectomy (EVT) is safe and effective in the treatment of anterior circulation AIS. EVT has been recommend as the first-line treatment for anterior circulation large vessel occlusion (LVO) stroke by guidelines. Symptomatic intracranial hemorrhage (sICH) and malignant cerebral edema (MCE) are the two most common severe neurological complications, leading to brain tissue hypoxia and neurological dysfunction. Currently, there is a lack of prediction system to identify patients at high risk for severe complications, who can most likely benefit from adjuvant treatment after thrombectomy to improve patient functional independence and survival rate.
Interventions
None listed
Sponsors
Xuanwu Hospital, Beijing
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
1. Symptoms and signs compatible with ischemia in the anterior circulation 2. Internal carotid artery occlusion or middle cerebral artery M1 and M2 segment occlusion confirmed by computed tomographic angiography (CTA)/ magnetic resonance angiography (MRA)/ digital subtraction angiography (DSA) 3. Premorbid mRS ≤1; 4. National Institutes of Health Stroke Score (NIHSS) ≥6 at admission; 5. Onset to puncture time ≤24h; 6. Treated with thrombectomy resulting in mTICI score ≥2b at end of the procedure.
Exclusion criteria
1. Intracranial hemorrhage, aneurysm, and arteriovenous malformation before endovascular thrombectomy; 2. Perioperative complications, including dissection and arterial perforation; 3. Anticipated life expectancy \<3 months; 4. Critical baseline clinical, laboratory and imaging data are missing; 5. Lack of follow-up results within 72 hours and 90 days after thrombectomy; 6. Pregnant or lactating women; 7. Severe systemic diseases (e.g. advanced cancer), potentially interfering with prognosis; 8. Allergy to contrast media and nitinol; 9. Concurrent participation in a study that would interfere with the establishment of predictive models; 10. Unable to complete the assessment due to mental disorders cognitive or emotional disorders before onset.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of severe complications | Within 72 hours after thrombectomy | Severe complications include symptomatic intracranial hemorrhage (sICH) and malignant cerebral edema (MCE). SICH was defined as any intracranial hemorrhage on the non-contrast CT scan accompanied with clinical deterioration, as defined by a increase of ≥4 points in the NIHSS score, or that led to death and that was identified as the predominant cause of the neurologic deterioration. MCE was defined as a malignant state in which neurological function deteriorates progressively due to brain edema after endovascular thrombectomy, causing disturbance of consciousness, anisocoria, and midline shift of 5 mm or more on imaging, leading to brain herniation or death. Midline shift was obtained by measuring the point of maximum deviation perpendicular to the line connecting the anterior and posterior attachment points of the falx cerebri. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of mRS score of 5-6 | 90 days (±7 days) after thrombectomy | The mRS score range from 0 (no disability) to 6 (death) |
| Rate of symptomatic intracranial hemorrhage | Within 72 hours after thrombectomy | SICH was defined as any intracranial hemorrhage on the non-contrast CT scan accompanied with clinical deterioration, as defined by a increase of ≥4 points in the NIHSS score, or that led to death and that was identified as the predominant cause of the neurologic deterioration. |
| Rate of malignant cerebral edema | Within 72 hours after thrombectomy | MCE was defined as a malignant state in which neurological function deteriorates progressively due to brain edema after endovascular thrombectomy, causing disturbance of consciousness, anisocoria, and midline shift of 5 mm or more on imaging, leading to brain herniation or death. Midline shift was obtained by measuring the point of maximum deviation perpendicular to the line connecting the anterior and posterior attachment points of the falx cerebri. |
| Rate of mRS score of 3-6 | 90 days (±7 days) after thrombectomy | The mRS score range from 0 (no disability) to 6 (death) |
| Rate of modified Rankin Scale (mRS) score of 0-2 | 90 days (±7 days) after thrombectomy | The mRS score range from 0 (no disability) to 6 (death) |
| All-cause mortality | 90 days (±7 days) after thrombectomy | Death defined as a mRS score of 6 |
| Change of NIHSS score | 24-72 hours after thrombectomy versus admission | The NIHSS score range from 0 (no deficit) to 42 (maximum deficit) |
Countries
China
Outcome results
None listed