NCT06418698招募中不适用
The Prediction of Intracranial Artery Calcification on Adverse Outcomes of Large Vessel Occlusive, Acute Ischemic Stroke Patients After Mechanical Thrombectomy: A Prospective Cohort, Observational Study
Zhujiang Hospital1 个研究点 分布在 1 个国家目标入组 434 人开始时间: 2024年3月28日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 434
- 试验地点
- 1
- 主要终点
- Proportion of patients with a adverse functional outcome at 3 months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or non-pregnant women with acute stroke symptoms aged over 18 years.
- •Occlusion of the intracranial internal carotid artery, the middle cerebral artery, the anterior cerebral artery, the posterior cerebral artery, basilar artery and intracranial vertebral artery confirmed by CT, MR angiography, or digital subtraction angiography.
- •No absolute contraindication to iodinated contrast media.
- •Planned treatment with EVT by clinical care team.
- •Informed consent obtained from patients or their legal representatives.
- •Willing to be followed up as required by the clinical study protocol.
排除标准
- •Acute ischemic stroke occurs over 24 hours of time last known well.
- •Neurologic deficits caused by diagnoses other than ischemic stroke, such as intracerebral hemorrhage, subarachnoid hemorrhage, or intracranial tumors.
- •With other underlying factors leading to IAC, such as hyperthyroidism, end-stage renal disease, long-term oral intake of vitamin K antagonist(Warfarin), chronic vitamin D deficiency or overdose, persistent hypomagnesemia, persistent hypercalcemia, persistent hyperphosphatemia and high oral calcium intake.
- •Lack of non-contract CT images on admission and significant artifacts in CT images preventing IAC measurement.
- •Severe renal insufficiency (estimated glomerular filtration rate < 30ml/min or serum creatinine > 220μmol/L (2.5mg/dl)).
- •Previous cerebrovascular intervention treatment or craniotomy.
结局指标
主要结局
Proportion of patients with a adverse functional outcome at 3 months
时间窗: 90(±7) days
Modified Rankin Scale(mRS) score \> 2
次要结局
- Proportion of patients with any ICH within 48 hours(Within 48 hours)
- Proportion of patients with new cerebrovascular events related with previous vessel occlusion at 3 years(1095(±30) days)
- Change of the NIHSS score at 6 days or discharge if earlier from baseline(6(±1) days)
- Proportion of substantial reperfusion at final angiogram(0 day)
- Proportion of substantial reperfusion at final angiogram without any rescue methods(0 day)
- Change of the NIHSS score at 24 hours from baseline(24 hours)
- Health-related quality of life at 3 months(90(±7) days)
- Mortality at 3 months(90(±7) days)
- Proportion of patients without disability at 3 months(90(±7) days)
- Proportion of patients with functional independence at 3 months(90(±7) days)
- Proportion of patients ambulatory or bodily needs-capable or better at 3 months(90(±7) days)
- Proportion of substantial reperfusion at first angiogram(0 day)
- Procedure-related complications(Up to 24 hours)
- Proportion of patients with new cerebrovascular events irrelated with previous vessel occlusion at 1 year(365(±30) days)
- Proportion of patients with Symptomatic intracranial hemorrhage(sICH) within 48 hours(Within 48 hours)
- Incidence of serious adverse events(Within 3 years)
- Proportion of patients with new cerebrovascular events related with previous vessel occlusion at 1 year(365(±30) days)
- Proportion of patients with new cerebrovascular events irrelated with previous vessel occlusion at 3 years(1095(±30) days)
研究者
研究点 (1)
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