跳至主要内容
临床试验/NCT03874702
NCT03874702Enrolling By Invitation不适用

Assisted Method for the Quantification, Localization and Automated Diagnosis of Stroke in Computed Tomography With the Use of Artificial Intelligence

University of Guadalajara1 个研究点 分布在 1 个国家目标入组 350 人开始时间: 2019年8月15日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
350
试验地点
1
主要终点
Alberta Stroke Program Early Computed Tomography Score

研究概览

简要总结

The use of the systems of machine learning for the quantification, location and diagnosis of ischemic stroke in non-contrasted head computed tomography, is a method with high efficacy, accessible and susceptible for standardization, for the assistance in the clinical decision making in the absence of specialized health personnel for the attention of this disease.

详细描述

PROBLEM STATEMENT Stroke is the fifth cause of death in the United States and the number one cause of long term disability. Annually around 800,000 persons are diagnosed with stroke in this country, causing the death of around 130,000 persons, each 4 minutes one person die due to this disease in the U.S.A.

In Mexico there is very few statistical information published about stroke, according to the Mexican clinical practice guidelines "CENETEC" this disease was the third cause of death, with the 5.6% percent of the main death causes, with an estimated rate of 25.6/100,000 habitants and more than 25,000 deaths per year according to data of the health department.

The monetary cost of the direct attention and the indirect expenses is enormous, with an approximate expenditure of 34 billion dollars per year. Around 20% of the survivors require special care during the first 3 months after a stroke event and around 30% remain with a severe disability.

In Mexico there is an alarming increase of stroke cases that correlates with the demographic transition to an older population, and also to the increase of risk factors for vascular atherothrombotic disease, as the hypertension, diabetes, obesity and dyslipidemia.

Local statistics show that from the different type of stroke the distribution in Mexico is: 72.94% as ischemic stroke, 20.17% hemorrhagic and 6.8% with subarachnoid hemorrhage, this numbers are similar to the statistic reported in the literature of other countries.

研究设计

研究类型
Observational
观察模型
Case Only
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

  • •Patients with ischemic stroke.
  • •Patients with <4.5 hours of symptom onset.

排除标准

  • •Patients with hemorrhagic stroke diagnosis.
  • •Patients with other cerebrovascular diseases.

结局指标

主要结局

Alberta Stroke Program Early Computed Tomography Score

时间窗: 1 day

The Alberta stroke programme early CT score (ASPECTS) 1 is a 10-point quantitative topographic CT scan score used in patients with middle cerebral artery stroke. It has also been adapted for the posterior circulation. Scoring system Segmental assessment of the MCA vascular territory is made and 1 point is deducted from the initial score of 10 for every region involved: caudate putamen internal capsule insular cortex M1: "anterior MCA cortex," corresponding to frontal operculum M2: "MCA cortex lateral to insular ribbon" corresponding to anterior temporal lobe M3: "posterior MCA cortex" corresponding to posterior temporal lobe M4: "anterior MCA territory immediately superior to M1" M5: "lateral MCA territory immediately superior to M2" M6: "posterior MCA territory immediately superior to M3"

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ivan Segura Duran

Principal Investigator

University of Guadalajara

研究点 (1)

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