Prediction of Risk Factors for Adverse Events After Head and Neck Vascular Recanalization Surgery Based on Machine Learning Models

• Sponsor: Tang-Du Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT06120478
• Collaborator: (none)
• Enrollment: 1,300
• Location: 1
• Actual Duration (Months): 57
• Patients Per Site Per Month: 22.8

Study Details

Study Description

Brief Summary

Prediction of risk factors for adverse events after head and neck vascular recanalization surgery based on machine learning models

Condition or Disease	Intervention/Treatment	Phase
Machine Learning	Other: observe

Study Design

• Study Type: Observational
• Actual Enrollment: 1300 participants
• Observational Model: Other
• Time Perspective: Retrospective
• Official Title: The Second Affiliated Hospital of Air Force Military Medical University
• Actual Study Start Date: Jan 1, 2019
• Actual Primary Completion Date: Nov 1, 2022
• Actual Study Completion Date: Oct 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
xi'an	Other: observe; observational study
shanxi	Other: observe; observational study

Outcome Measures

Primary Outcome Measures

1. death [one year]

Secondary Outcome Measures

1. Recurrence of stroke [one year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• (1) All enrolled patients were diagnosed with clear head and neck artery stenosis and a risk event after head and neck revascularization;

(2) Location of lesion: origin of internal carotid artery, bifurcation of internal and external carotid arteries;

(3) Patients with symptomatic head and neck artery stenosis and dangerous events after head and neck blood flow reconstruction, and with a degree of stenosis ≥ 70% on non-invasive examination or stenosis ≥ 50% found on angiography;

(4) Asymptomatic head and neck artery stenosis and risk events after head and neck revascularization, with a degree of stenosis ≥ 70% on non-invasive examination or stenosis ≥ 60% found on angiography;

(5) Asymptomatic head and neck artery stenosis and dangerous events after head and neck blood flow reconstruction, with a non-invasive examination of stenosis degree less than 70%, but angiography or other examinations indicate that the stenosis lesion is in an unstable state;

(6) Symptomatic head and neck artery stenosis and risk events after head and neck revascularization, non-invasive examination of head and neck artery stenosis and risk events after head and neck revascularization are 50% to 69%;

(7) Sign the project informed consent form

Exclusion Criteria:

• (1) Patients with poor overall condition and intolerance to general anesthesia;

(2) Patients with mental illness or severe mental illness;

(3) Severe respiratory system diseases;

(4) Pregnant and lactating women;

(5) Participating in another clinical study;

(6) Patients with advanced tumors or those who are expected to die within one year;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tangdu Hospital	Xi'an	Shaanxi	China	710038

Sponsors and Collaborators

• Tang-Du Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tang-Du Hospital
• ClinicalTrials.gov Identifier: NCT06120478
• Other Study ID Numbers: Bei Liu
• First Posted: Nov 7, 2023
• Last Update Posted: Nov 7, 2023
• Last Verified: Nov 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Nov 7, 2023