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临床试验/NCT05643664
NCT05643664尚未招募不适用

"Pilot Randomized Prospective Clinical Study of the Effectiveness of the Use of Artificial Intelligence in Determining the "Safe" Clamping Zones in the Surgical Treatment of Abdominal Aortic Aneurysms

Meshalkin Research Institute of Pathology of Circulation7 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
100
试验地点
7
主要终点
frequency of intraoperative and early postoperative embolism

研究概览

简要总结

"Pilot randomized prospective clinical study of the effectiveness of the use of artificial intelligence in determining "safe" clamping zones in the surgical treatment of abdominal aortic aneurysms."

详细描述

Abdominal aortic aneurysm is a life-threatening disease, a formidable complication of which is an aneurysm rupture (Editor's Choice - European Society for Vascular Surgery). The main method of treating aneurysms is surgical reconstruction, including open or endovascular intervention ((ESVS) 2019 Clinical Practice Guidelines on the Management of Abdominal Aorto-iliac Artery Aneurysms). Anatomical features of aneurysms and the presence of intraluminal thrombomass are among the criteria in deciding on the tactics of surgical treatment. These factors carry additional technical difficulties and lead to the development of intraoperative complications, including ischemic ones. Ischemia of the lower extremities is the most common complication and can be caused by thrombosis, embolism or dissection of the aortic wall (occurs in 7% of patients) (Complications Associated with Aortic Aneurysm Repair).

Thus, in order to reduce the frequency of embolic complications, it is important for the surgeon to determine a "safe" zone for applying a clamp to the aorta and main vessels. Thus, artificial intelligence (AI) can be used to interpret and analyze images of aneurysms that allow automatic quantitative measurements and determination of the exact characteristics of morphology and hydrodynamics, as well as the presence of intraluminal blood clots and calcifications. Analysis based on artificial intelligence can lead to the development of computational programs for predicting the development of aneurysms and the risk of their rupture, as well as postoperative outcomes. Artificial intelligence can also be used to determine the "safe" areas of aortic clamping. (Artificial intelligence in abdominal aortic aneurysm).

Adam and co-authors trained a neural network to detect and estimate the maximum outer diameter of aneurysms using a database of 489 CT angiographs of abdominal aortic aneurysms. AI has achieved a level of performance and accuracy suitable for clinical practice, and with the use of more CT images, further improvement in accuracy is expected (Pre-surgical and Post-surgical Aortic Aneurysm Maximum Diameter Measurement: Full Automation by Artificial Intelligence). In a study by Fujiwara et al. 145 non-contrast CT scans with suspected aneurysm were retrospectively collected. Initially, AI was trained by manually segmenting CT images. Image processing was used to determine the abdominal aortic aneurysm area and to automatically measure the size. This method has shown that AI is a useful tool for fully automatic detection and measurement of aneurysm diameter. (Fully automatic detection and measurement of abdominal aortic aneurysm using artificial intelligence). Florent Lalys and his coauthor. an automatic fast and universal algorithm for determining an intraluminal thrombus was developed. The method was tested on pre- and postoperative CT scans of the abdominal aorta and iliac artery of 145 patients and consists in determining the central line and segmentation of the aortic lumen, an optimized stage of pretreatment and the use of a 3D model (Generic thrombus segmentation from pre- and post-operative CTA).

Taking into account the references already available in some studies of the use of artificial intelligence for the treatment of cardiovascular diseases, its use is seen as a promising method for making decisions in determining "safe" clamping zones in the surgical treatment of abdominal aortic aneurysms, which will reduce the frequency of postoperative complications.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
45 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with aneurysmal dilation of the abdominal aorta, who are shown surgery.
  • Patients who have agreed to participate in this study

排除标准

  • Chronic heart failure of functional class III -IV according to NYHA classification;
  • Chronic decompensated "pulmonary" heart;
  • Severe hepatic or renal insufficiency (bilirubin >35 mmol/l, glomerular filtration rate <60 ml/min);
  • Polyvalent drug allergy;
  • Malignant oncological diseases in the terminal stage with a predicted life span of up to 6 months;
  • Acute cerebrovascular accident;

结局指标

主要结局

frequency of intraoperative and early postoperative embolism

时间窗: 12 months

Number of intraoperative embolism according to intraoperative ultrasound monitoring. The number of developed occlusions of peripheral arteries according to ultrasound scanning

次要结局

  • MALE(12 months)
  • secondary patency of the operated segment(12 months)
  • Primary patency of the operated segment.(12 months)

研究者

发起方
Meshalkin Research Institute of Pathology of Circulation
申办方类型
Network
责任方
Sponsor

研究点 (7)

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