Intracranial Artery Occlusion With Infarction (Disorder)
Conditions
Keywords
ischemic stroke, endovascular treatment, registry
Brief summary
Endovascular thrombectomy (EVT) is effective and safe for acute ischemic stroke (AIS) caused by large vessel occlusion (LVO) in major clinical trials. Whether the benefit of EVT in randomized trials could be generalized to clinical practice, especially in developing countries, remains unknown. The prospective Chinese ANGEL-ACT Registry (Endovascular Treatment Key Technique and Emergency Work Flow Improvement of Acute Ischemic Stroke) was established to evaluate the utilization, and subsequent outcomes of EVT treated AIS patients. This study is a multi-center, prospective registry study initiated by researchers, funded by National Key R&D Program of China. A total of 2,000 patients with acute ischemic stroke will undergo endovascular treatment. The hypothesis was that favorable outcomes from clinical trials could be achieved in clinical practice in China.
Interventions
None listed
Sponsors
Beijing Tiantan Hospital
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years old; 2. Diagnosis of acute ischemic stroke; 3. Imaging confirmed intracranial large artery occlusion (LVO): intracranial internal carotid artery (ICA T/L), middle cerebral artery (MCA M1/M2), anterior cerebral artery (ACA A1/A2), basilar artery (BA), vertebral artery (VA V4), and posterior cerebral artery (PCA P1); 4. Initiation of any type of endovascular treatment (EVT), including intra-arterial thrombolysis, mechanical thrombectomy, angioplasty, and stenting; 5. The patient or the patient's legal representative is able and willing to sign the informed consent.
Exclusion criteria
1. Isolated cervical ICA or VA occlusion; 2. No evidence of LVO on DSA.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional independence at 90 days (modified Rankin Scale of 0-2) | 90±7 days after enrollment | The range of modified Rankin Scale was from 0 to 6. 0-No symptoms;1-No significant disability;2-Slight disability;3-Moderate disability;4-Moderately severe disability;5-Severe disability;6 -Dead.A higher score indicates worse a outcome. |
| Symptomatic intracranial hemorrhage (sICH) within 12-36 hours after the procedure | 12-36 hours after the procedure | Heidelberg Bleeding Classification): new intracranial hemorrhage detected by brain imaging associated with ≥4 points total National Institutes of Health Stroke Scale (NIHSS), ≥2 points in one NIHSS category, leading to intubation/ hemicraniectomy/ EVD placement or other major medical/surgical intervention, or absence of alternative explanation for deterioration |
| Time from symptom onset to recanalization | The end of the procedure | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in NIHSS score 24 hours after the procedure | 24 hours after the procedure | difference between NIHSS score 24 hours after the procedure and baseline |
| Changes in NIHSS score 7 days after the procedure or at discharge | 7 days after the procedure or discharge | difference between NIHSS score 7 days after the procedure or discharge and baseline |
| EQ-5D 90 days after the procedure | 90±7 days after the procedure | EQ-5D is a standardized instrument for measuring generic health status. Rated level can be coded as a number 1, 2, or 3, which indicates having no problems for 1, having some problems for 2, and having extreme problems for 3. As a result, a person's health status can be defined by a 5-digit number, ranging from 11111 (having no problems in all dimensions) to 33333 (having extreme problems in all dimensions).A higher score indicates a better outcome. |
| Barthel index (BI) 90 days after the procedure | 90±7 days after the procedure | The BI has a score of 0-100. A higher score indicates a better outcome. |
| Parenchymal hematoma (PH2) | 12-36 hours after the procedure | PH2 is defined as hematoma in \>30% of infarct area |
| Recanalization rate at the end of the procedure | at the end of the procedure | mTICI score 2b-3 |
| All-cause mortality within 90 days | 90±7 days after the procedure | — |
| Time from onset to arrival | At baseline, after arrival at the hospital | — |
| Time from arrival to imaging | At baseline, after taking any brain imaging | — |
| Time from imaging to puncture | At baseline, during the procedure, after successful groin puncture | — |
| Time from puncture to recanalization | At baseline, during the procedure, after successful recanalization | — |
| Any intracranial hemorrhage on imaging | 12-36 hours after the procedure | — |
| Recanalization rate after the first attempt | At baseline, during the procedure, after the first attempt of endovascular treatment | mTICI score 2b-3 |
| Changes in NIHSS score immediately after the procedure | within 2 hours after the procedure | difference between NIHSS score immediately after the procedure and baseline |
Countries
China
Outcome results
None listed