跳至主要内容
临床试验/NCT07570680
NCT07570680招募中不适用

Construction of an Integrated Intelligent Model for Spontaneous Intracerebral Hemorrhage Based on Deep Learning

Second Affiliated Hospital of Nanchang University1 个研究点 分布在 1 个国家目标入组 7,100 人开始时间: 2022年9月1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
7,100
试验地点
1
主要终点
Area Under Curve

研究概览

简要总结

Although hemorrhagic stroke also has the characteristics of high mortality and disability rates, and constitutes a major public health problem worldwide, there is a relative lack of in-depth research teams for hemorrhagic stroke in China. The current preoperative imaging evaluation of spontaneous cerebral hemorrhage is still limited to the traditional Tada formula, and there are subjective differences in diagnosis among different doctors, making it difficult to achieve homogenization in clinical decision-making. Hemorrhagic stroke is a common and frequently occurring disease in Jiangxi Province. Therefore, establishing a new diagnosis and treatment system focused on hemorrhagic stroke can not only fill the research gap in this field in China, improve the accuracy and homogeneity of hemorrhagic stroke diagnosis and treatment, but also promote related research progress to reduce the mortality and disability rates of this disease and improve the clinical prognosis of patients.

详细描述

Hemorrhagic stroke is a serious cerebrovascular disease, accounting for about 20% of all strokes. It refers to cerebral hemorrhage and subarachnoid hemorrhage caused by intracranial vascular diseases such as intracranial aneurysms, cerebral and spinal vascular malformations and moyamoya disease under the effect of blood flow. It has the characteristics of high incidence rate, high disability rate and high mortality rate, and has caused huge economic burden to patients, families and society.

Hemorrhagic stroke is one of the high-risk diseases in Jiangxi Province, and has become a major public health challenge and a key social issue that urgently needs to be addressed. On the one hand, the diagnosis and treatment of hemorrhagic stroke have a certain degree of complexity, involving multiple disciplines, especially neurology and endocrinology, which have established multiple diagnostic, evaluation, treatment, and rehabilitation systems. Different systems have different focuses, but limited by the level of understanding of the disease, there have been only basic treatment principles for decades, and there has been no breakthrough in specific treatment plans. On the other hand, with the development of the economy and the improvement of living standards, clinical physicians and patients not only focus on the survival rate after hemorrhagic stroke, but also pay more attention to neurological function recovery and long-term quality of life. Due to the limitations of detection technology in the past, it was difficult to accurately describe diseases and truly develop individualized diagnosis and treatment plans, resulting in significant differences in patient prognosis. How to leverage advances in diagnosis and treatment technology to ultimately achieve precision, individualization, and homogenization in the diagnosis and treatment of hemorrhagic stroke is a key focus for the future.

Although hemorrhagic stroke also has the characteristics of high mortality and disability rates, and constitutes a major public health problem worldwide, there is a relative lack of in-depth research teams for hemorrhagic stroke in China. The current preoperative imaging evaluation of spontaneous cerebral hemorrhage is still limited to the traditional Tada formula, and there are subjective differences in diagnosis among different doctors, making it difficult to achieve homogenization in clinical decision-making. Hemorrhagic stroke is a common and frequently occurring disease in Jiangxi Province. Therefore, establishing a new diagnosis and treatment system focused on hemorrhagic stroke can not only fill the research gap in this field in China, improve the accuracy and homogeneity of hemorrhagic stroke diagnosis and treatment, but also promote related research progress to reduce the mortality and disability rates of this disease and improve the clinical prognosis of patients.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
8 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age >= 8 years old;
  • Patients diagnosed with spontaneous hemorrhagic stroke based on medical history and auxiliary examinations;
  • Received non-contrast computed tomography (NCCT) in the outpatient or emergency department;
  • Treated in accordance with standard clinical guidelines during hospitalization;
  • Have complete clinical data.

排除标准

  • Had undergone surgical treatment in another hospital before admission;
  • Was in a state of shock upon admission;
  • Had severe heart, liver, or kidney dysfunction or other life-threatening systemic diseases;
  • Died during hospitalization;
  • Had an expected lifespan of less than six months or was unable to complete the study follow-up for other reasons.

结局指标

主要结局

Area Under Curve

时间窗: 90-day and 180-day

90-day and 180-day mRS score, survival status, functional independence (Barthel index).

次要结局

  • Sensitivity ,Specificity,True Positive Rate,False Positive Rate(Baseline (admission), 24 hours postoperatively, 3 days postoperatively, 7 days postoperatively, discharge, 90-day follow-up, 180-day follow-up)

研究者

发起方
Second Affiliated Hospital of Nanchang University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xingen Zhu

Professor, Chief Physician

Second Affiliated Hospital of Nanchang University

研究点 (1)

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