跳至主要内容
临床试验/NCT05566002
NCT05566002招募中不适用

Artificial Intelligence-Assisted Evaluation of Pulmonary Hypertension

Chinese Pulmonary Vascular Disease Research Group1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2022年6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
2,000
试验地点
1
主要终点
Accuracy of diagnosis by artificial intelligence-assisted algorithm

研究概览

简要总结

Pulmonary hypertension represents a challenging and heterogeneous condition that is associated with high mortality and morbidity if left untreated. Artificial intelligence is used to study and develop theories and methods that simulate and extend human intelligence, which is being applied in fields related to cardiovascular diseases. The study intends to combine multimodal clinical data of patients who undergo right heart catheterization at Fuwai Hospital with artificial intelligence techniques to create programs that can screen and diagnose pulmonary hypertension.

详细描述

Patients with pulmonary hypertension (PH) represent a challenging and heterogeneous cohort with high morbidity and mortality if left untreated. To make a definitive diagnosis of PH, one needs to conduct an invasive right heart catheterization (RHC) in order to assess the mean pulmonary artery pressure (mPAP). As PH occurs sporadically in various medical conditions, including connective tissue disease, and congenital heart disease, and presenting symptoms are non-specific, there is a need to raise the suspicion of PH early in the community. For this reason, noninvasive tools that are widely available for upfront screening would be ideal to enable timely diagnosis of PH. Transthoracic echocardiography has emerged as the mainstay for screening of PH, yet the sensitivity and specificity of this approach remain limited even in experienced hands. As high-throughput technologies advance and access to PH big data improve, it will be critical to prudently select artificial intelligence approaches for data analysis, visualization, and interpretation. By combining the multimodal clinical data (such as indicators from chest X-ray, electrocardiography, and echocardiography), this study aims to develop artificial intelligence-assisted programs to assist the screening and diagnosis of PH, and to evaluate its diagnostic accuracy for PH as compared with RHC, and to estimate whether this approach outperforms the conventional echocardiographic method.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

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

入选标准

  • Age ≥18 years old
  • Patients previously received chest X-ray, electrocardiography, echocardiography, other routine examinations, and RHC at the Fuwai Hospital, CAMS & PUMC, Beijing, China

排除标准

  • Patients without RHC
  • The quality of routine examinations and RHC cannot meet the requirement for further analysis
  • Severe loss of results of routine examinations (chest X-ray, electrocardiography, echocardiography, etc.)

结局指标

主要结局

Accuracy of diagnosis by artificial intelligence-assisted algorithm

时间窗: Baseline

The investigators will calculate the area under the receiver operating characteristic curve of diagnosis by artificial intelligence-assisted algorithm and compare this index between artificial intelligence-assisted algorithm and RHC.

次要结局

  • Sensitivity of diagnosis by artificial intelligence algorithm(Baseline)
  • Specificity of diagnosis by artificial intelligence algorithm(Baseline)

研究者

发起方
Chinese Pulmonary Vascular Disease Research Group
申办方类型
Other
责任方
Sponsor

研究点 (1)

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