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临床试验/NCT04598997
NCT04598997招募中不适用

Artificial Intelligence With DEep Learning on COROnary Microvascular Disease

University Hospital, Grenoble1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2020年10月20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
600
试验地点
1
主要终点
Death or re-hospitalization for heart Failure

研究概览

简要总结

Despite the progress made in the management of myocardial infarction (MI), the associated morbidity and mortality remains high. Numerous scientific data show that damage of the coronary microcirculation (CM) during a STEMI remains a problem because the techniques for measuring it are still imperfect. We have simple methods for estimating the damage to the MC during the initial coronary angiography, the best known being the calculation of the myocardial blush grade (MBG), but which is semi-quantitative and therefore not very precise, or more precise imaging techniques, such as cardiac MRI, which are performed 48 hours after the infarction and which make the development of early applicable therapeutics not very propitious. Finally, lately, the use of special coronary guides to measure a precise CM index remains non-optimal because it prolongs the procedure. However, the information is in the picture and this information could allow the development of therapeutic strategies adapted to the patient's CM. Indeed, the arrival of iodine in CM increases the density of the pixels of the image, this has been demonstrated by the implementation in 2009 of a software allowing the calculation of the MBG assisted by computer. But the performances of this software did not allow its wide diffusion. Today, the field of medical image analysis presents dazzling progress thanks to artificial intelligence (AI). Deep Learning, a sub-category of Machine Learning, is probably the most powerful form of AI for automated image analysis today. Made up of a network of artificial neurons, it allows, using a very large number of known examples, to extract the most relevant characteristics of the image to solve a given problem. Thus, it uses thousands of pieces of information, sometimes imperceptible to the naked eye. We hypothesize that a supervised Deep Learning algorithm trained with a set of relevant data, will be able to identify a patient with a pejorative prognosis, probably related to a microcirculatory impairment visible in the image.

详细描述

The aim of this study is to develop an algorithm capable of identifying patients with poor prognosis criteria at the time of hospitalization for STEMI, despite successful revascularization by analyzing coronary angiography images using supervised Deep Learning type artificial intelligence methods.

The protocol will be subdivided into 4 steps:

  • Step 1: Patient selection

Data mining to identify and select patients via PMSI data. Patients will be contacted by telephone follow-up to check the participation agreement and collect the primary outcome. Other data from the patient's medical file will be collected through PREDIMED.

  • Step 2: Data annotation

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

入选标准

  • Age over 18 years
  • Patients who have undergone coronary angioplasty revascularization at CHUGA for STEMI from 2015 to 2018 for which images are usable.
  • Patient affiliated with social security
  • Non-opposition to participation

排除标准

  • Coronary artery image not usable
  • Patient under guardianship or deprived of liberty

结局指标

主要结局

Death or re-hospitalization for heart Failure

时间窗: Baseline (at the time of the phone call) - From nov 2020 and jan 2021 [anticipated]

The predictive accuracy will be evaluated by calculating the sensitivity, specificity, positive predictive value, and negative predictive value on the test cohort.

次要结局

  • Algorithm study(After data annotation (step 2) and developping the algorithm (step 3) - In Jan 2022 [anticipated])

研究者

发起方
University Hospital, Grenoble
申办方类型
Other
责任方
Sponsor

研究点 (1)

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