CAIS-MT is a single-center, prospective cohort study, to evaluate the correlation between outcomes of endovascular treatment(EVT) and intracranial artery calcification(IAC) in patients with acute ischemic stroke due to large or medium vessel occlusion.
This study have to objective to evaluate the predictive value of IAC Agatston score in patients with acute ischemic stroke due to large or medium vessel occlusion on worse angiographic and functional outcomes after EVT. The result of this study will provide a upfront basis for risk stratification of adverse outcomes of EVT by using quantitative IAC, so as to get a reference for an individualized and precise plan of EVT.
Study Type
OBSERVATIONAL
Enrollment
434
Zhujiang Hospital, Southern Medical University
Guangzhou, Guangdong, China
RECRUITINGProportion of patients with a adverse functional outcome at 3 months
Modified Rankin Scale(mRS) score \> 2
Time frame: 90(±7) days
Proportion of patients without disability at 3 months
mRS score 0-1
Time frame: 90(±7) days
Proportion of patients with functional independence at 3 months
mRS score 0-2
Time frame: 90(±7) days
Proportion of patients ambulatory or bodily needs-capable or better at 3 months
mRS score 0-3
Time frame: 90(±7) days
Change of the NIHSS score at 24 hours from baseline
Change of the NIHSS score at 24 hours from baseline
Time frame: 24 hours
Change of the NIHSS score at 6 days or discharge if earlier from baseline
Change of the NIHSS score at 6 days or discharge if earlier from baseline
Time frame: 6(±1) days
Health-related quality of life at 3 months
Health-related quality of life is assessed with the European Quality Five Dimensions Five Level scale (EQ-5D-5L)
Time frame: 90(±7) days
Proportion of substantial reperfusion at final angiogram
Substantial reperfusion is defined as a expanded Treatment in Cerebral Infarction score of 2b50 (50 to 67% reperfusion), 2b67 (67 to 89% reperfusion), 2c(90 to 99% reperfusion) or 3 (complete reperfusion)
Time frame: 0 day
Proportion of substantial reperfusion at final angiogram without any rescue methods
Substantial reperfusion is defined as a expanded Treatment in Cerebral Infarction score of 2b50 (50 to 67% reperfusion), 2b67 (67 to 89% reperfusion), 2c(90 to 99% reperfusion) or 3 (complete reperfusion)
Time frame: 0 day
Proportion of substantial reperfusion at first angiogram
Substantial reperfusion is defined as a expanded Treatment in Cerebral Infarction score of 2b50 (50 to 67% reperfusion), 2b67 (67 to 89% reperfusion), 2c(90 to 99% reperfusion) or 3 (complete reperfusion)
Time frame: 0 day
Proportion of patients with Symptomatic intracranial hemorrhage(sICH) within 48 hours
ICH will be evaluated according to the Heidelberg Bleeding Classification. sICH is diagnosed if the new observed ICH is associated with any of the following conditions: 1) NIHSS score increased more than 4 points than that immediately before worsening; 2) NIHSS score increased more than 2 points in one category; 3) Deterioration led to intubation, hemicraniectomy, external ventricular drain placement or any other major interventions. Additionally, the symptom deteriorations could not be explained by causes other than the observed ICH.
Time frame: Within 48 hours
Proportion of patients with any ICH within 48 hours
ICH will be evaluated according to the Heidelberg Bleeding Classification.
Time frame: Within 48 hours
Mortality at 3 months
Mortality rates are defined as the number of deaths observed divided by the number of subjects observed over the 90-day study period.
Time frame: 90(±7) days
Incidence of serious adverse events
Including but not limited to acute respiratory failure, severe or malignant cerebral artery infarction, acute heart failure, debridement decompression, and other major medical events that can result in death, immediately life-threatening, hospitalization or prolongation of this hospitalization, terminally or severely disabling/incapacitating, the loss of a significant ability to maintain normal life functioning, or medical intervention to avoid the above outcomes.
Time frame: Within 3 years
Procedure-related complications
such as arterial perforation, iatrogenic arterial dissection, embolization in previously uninvolved vascular territory, arterial access site hematoma, and retroperitoneal hematoma. Arterial perforation will be defined at angiography by the operator and associated with subarachnoid hemorrhage. Iatrogenic arterial dissection will be defined at angiography by the operator. Arterial access site hematoma will be assessed as a complication of arterial access puncture and defined by clinical examination and anatomic imaging. Retroperitoneal hematoma will be assessed as a complication of groin puncture and defined by imaging (ultrasound or CT or MR angiography). The definition of embolization in previously uninvolved vascular territory is noted after recanalization of the primary occlusion site, any vessel occlusions distal from the primary occlusion site are considered emboli due to periprocedural thrombus fragmentation.
Time frame: Up to 24 hours
Proportion of patients with new cerebrovascular events related with previous vessel occlusion at 1 year
New cerebrovascular events are defined as progression of ischemic lesion or newly hemorrhagic lesion.
Time frame: 365(±30) days
Proportion of patients with new cerebrovascular events related with previous vessel occlusion at 3 years
New cerebrovascular events are defined as progression of ischemic lesion or newly hemorrhagic lesion.
Time frame: 1095(±30) days
Proportion of patients with new cerebrovascular events irrelated with previous vessel occlusion at 1 year
New cerebrovascular events are defined as progression of ischemic lesion or newly hemorrhagic lesion.
Time frame: 365(±30) days
Proportion of patients with new cerebrovascular events irrelated with previous vessel occlusion at 3 years
New cerebrovascular events are defined as progression of ischemic lesion or newly hemorrhagic lesion.
Time frame: 1095(±30) days
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