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The Role of Artificial Intelligence in the Treatment of Abdominal Aortic Aneurysms

Primary Purpose

Frequency of Embolic Complications, Frequency of Ischemic Complications

Status
Not yet recruiting
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
prosthetics of the abdominal aorta
prosthetics of the abdominal aorta after determining the safe zones of clamping
Sponsored by
Meshalkin Research Institute of Pathology of Circulation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Frequency of Embolic Complications focused on measuring Aortic aneyrism, Artificial intelligence, "safe" zone of clamping, embolic complications

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients with aneurysmal dilation of the abdominal aorta, who are shown surgery. Patients who have agreed to participate in this study Exclusion Criteria: 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;

Sites / Locations

  • Alexander A Gostev
  • Federal State Institution Academician E.N.Meshalkin Novosibirsk State Research Institute Of Circulation Pathology Rusmedtechnology
  • Novosibirsk Research Institute of Circulation Pathology
  • E. Meshalkin National Medical Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standart technology

Artificial intellect

Arm Description

the zone of aortic and main artery clamping is determined by the surgeon intraoperatively.

The multispiral computed tomography data is evaluated using artificial intelligence and the definition of "safe" zones of aortic and main artery clamping is performed. Intraoperatively, clamping is performed in the settlement zones.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Primary patency of the operated segment.
The number of restenosis (50% or more) or reocclusion according to ultrasound duplex scanning of the operated segment at control points
secondary patency of the operated segment
The number of restenosis (50% or more) or reocclusion according to ultrasound duplex scanning of the operated segment after repeated intervention at control points
MALE
The number of major adverse events that occurred in the extremities the observation period

Full Information

First Posted
November 15, 2022
Last Updated
December 13, 2022
Sponsor
Meshalkin Research Institute of Pathology of Circulation
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1. Study Identification

Unique Protocol Identification Number
NCT05643664
Brief Title
The Role of Artificial Intelligence in the Treatment of Abdominal Aortic Aneurysms
Official Title
"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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2023 (Anticipated)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meshalkin Research Institute of Pathology of Circulation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
"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."
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frequency of Embolic Complications, Frequency of Ischemic Complications
Keywords
Aortic aneyrism, Artificial intelligence, "safe" zone of clamping, embolic complications

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
In both groups, aneurysmectomy with prosthetics of the abdominal aorta is performed using the standard technology. In the first group, the aortic and main artery clamping zone is determined by the surgeon intraoperatively. In the second group, before surgery, multispiral computed tomography data is evaluated using artificial intelligence and the definition of "safe" areas of aortic and main artery clamping is performed. Intraoperatively, clamping is performed in the settlement zones.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standart technology
Arm Type
Active Comparator
Arm Description
the zone of aortic and main artery clamping is determined by the surgeon intraoperatively.
Arm Title
Artificial intellect
Arm Type
Experimental
Arm Description
The multispiral computed tomography data is evaluated using artificial intelligence and the definition of "safe" zones of aortic and main artery clamping is performed. Intraoperatively, clamping is performed in the settlement zones.
Intervention Type
Procedure
Intervention Name(s)
prosthetics of the abdominal aorta
Intervention Description
aneurysmectomy is performed with prosthetics of the abdominal aorta using the standard technology.
Intervention Type
Procedure
Intervention Name(s)
prosthetics of the abdominal aorta after determining the safe zones of clamping
Intervention Description
aneurysmectomy is performed with prosthetics of the abdominal aorta using the standard technology. Before surgery, multispiral computed tomography data is evaluated using artificial intelligence and safe zones of aortic and arterial clampings are determined. Intraoperatively, clamping is performed in the settlement zones.
Primary Outcome Measure Information:
Title
frequency of intraoperative and early postoperative embolism
Description
Number of intraoperative embolism according to intraoperative ultrasound monitoring. The number of developed occlusions of peripheral arteries according to ultrasound scanning
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Primary patency of the operated segment.
Description
The number of restenosis (50% or more) or reocclusion according to ultrasound duplex scanning of the operated segment at control points
Time Frame
12 months
Title
secondary patency of the operated segment
Description
The number of restenosis (50% or more) or reocclusion according to ultrasound duplex scanning of the operated segment after repeated intervention at control points
Time Frame
12 months
Title
MALE
Description
The number of major adverse events that occurred in the extremities the observation period
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with aneurysmal dilation of the abdominal aorta, who are shown surgery. Patients who have agreed to participate in this study Exclusion Criteria: 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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrey A Karpenko, PhD
Phone
+79139504100
Email
andreikarpenko@rambler.ru
First Name & Middle Initial & Last Name or Official Title & Degree
Alexandr A Gostev, PhD
Phone
+79139555074
Email
a_gostev@meshalkin.ru
Facility Information:
Facility Name
Alexander A Gostev
City
Novosibirsk
State/Province
Novosibirskaya Obl
ZIP/Postal Code
630005
Country
Russian Federation
Facility Name
Federal State Institution Academician E.N.Meshalkin Novosibirsk State Research Institute Of Circulation Pathology Rusmedtechnology
City
Novosibirsk
ZIP/Postal Code
630055
Country
Russian Federation
Facility Name
Novosibirsk Research Institute of Circulation Pathology
City
Novosibirsk
ZIP/Postal Code
630055
Country
Russian Federation
Facility Name
E. Meshalkin National Medical Research Center
City
Novosibirsk
Country
Russian Federation

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
after the end of the study, receipt of the results and publication of the first data, these sections will be available to other researchers upon personal request.
IPD Sharing Time Frame
1 year after the first publication
IPD Sharing Access Criteria
access to data on a personal request
IPD Sharing URL
http://meshalkin.ru

Learn more about this trial

The Role of Artificial Intelligence in the Treatment of Abdominal Aortic Aneurysms

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