Machine LearningNCT06120478
Prediction of Risk Factors for Adverse Events After Head and Neck Vascular Recanalization Surgery Based on Machine Learning Models
An observational study of Machine Learning, run by Tang-Du Hospital at 1 site in China.
Trial summary
Prediction of risk factors for adverse events after head and neck vascular recanalization surgery based on machine learning models Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Machine Learning
- What is being tested?
- observe
- How many people
- 1,300 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 1 Oct 2023
- How long will I take part?
- 6 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing vascular recanalization surgery due to stroke
Who may be able to join
- All enrolled patients were diagnosed with clear head and neck artery stenosis and a risk event after head and neck revascularization;
- Location of lesion: origin of internal carotid artery, bifurcation of internal and external carotid arteries;
- 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;
- 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;
- 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;
- 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%;
- Sign the project informed consent form
Who cannot join
- Patients with poor overall condition and intolerance to general anesthesia;
- Patients with mental illness or severe mental illness;
- Severe respiratory system diseases;
- Pregnant and lactating women;
- Participating in another clinical study;
- Patients with advanced tumors or those who are expected to die within one year;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Second Affiliated Hospital of Air Force Military Medical University
Prediction of risk factors for adverse events after head and neck vascular recanalization surgery based on machine learning models
- Conditions
- Machine Learning
- Being tested
- observe
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observeOther
observational study
| Study group | Role | What they receive |
|---|---|---|
| xi'an | Not described Receives: Other: observe | |
| shanxi | Not described Receives: Other: observe |
What is being measured
The primary outcome is the main question the study is designed to answer.
death
Measured: one year
Secondary outcomes (1)
Recurrence of stroke
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start1 Jan 2019
- Primary completion1 Nov 2022
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Machine LearningStudies of the same condition, open and under way.
- More trials run by Tang-Du HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,300 participants (actual)
- Target duration
- 6 Years
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06120478
- Sponsor's protocol ID
- Bei Liu
- Status last verified
- Apr 2025
- First submitted
- 2 Nov 2023
- Last updated
- 16 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Second Affiliated Hospital of Air Force Military Medical University
- ClinicalTrials.gov ID
- NCT06120478
- Acronym / sponsor ID
- Bei Liu
- Conditions
- Machine Learning
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,300 participants (actual)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 7 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prediction of risk factors for adverse events after head and neck vascular recanalization surgery based on machine learning models
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| xi'an | – | Other: observe |
| shanxi | – | Other: observe |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing vascular recanalization surgery due to stroke
Key inclusion criteria (7 listed)
- All enrolled patients were diagnosed with clear head and neck artery stenosis and a risk event after head and neck revascularization;
- Location of lesion: origin of internal carotid artery, bifurcation of internal and external carotid arteries;
- 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;
- 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;
- 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;
Key exclusion criteria (6 listed)
- Patients with poor overall condition and intolerance to general anesthesia;
- Patients with mental illness or severe mental illness;
- Severe respiratory system diseases;
- Pregnant and lactating women;
- Participating in another clinical study;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observeobservational study | Other | shanxi, xi'an |
Primary outcome
death
Time frame: one year
1 secondary outcome
Recurrence of stroke
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Machine Learning, run by Tang-Du Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
death (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2025.