Coronary DiseaseNCT06544681
Evaluation and Treatment Strategy Development of Coronary Heart Disease Guided by OCT Based on Multimodal Deep Learning
An observational study of Coronary Disease and Coronary Artery Disease, run by Xiang Ma.
Trial summary
This is a retrospective, multicenter, observational study aimed at assessing stent apposition for coronary stent implantation by an optical coherence tomography system constructed by deep learning algorithms and evaluating the prognosis of patients after stent implantation in conjunction with multimodal diagnostic and… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Coronary Disease, Coronary Artery Disease
- What is being tested?
- Coronary stenting with planned drug eluting stent (DES).
- Type of treatment
- Surgery or procedure
- How many people
- 2,000 participants
- Where
- No sites listed yet
- Study dates
- 20 Aug 2024to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Retrospective data were collected from the First Affiliated Hospital of Xinjiang Medical University and Jining, Shandong Province from 2015 to 2022 Coronary artery disease patients undergoing coronary angiography and OCT examination in the First People's Hospital of China and Xigu District People's Hospital of Gansu Province.
Who may be able to join
- Age ≥20 years old;
- Angiography was performed, and OCT imaging of criminal blood vessels was performed before intervention;
- Type of coronary heart disease: Unstable angina pectoris (UA), ST elevation myocardial infarction (STEMI) And non-ST elevation myocardial infarction (NSTEMI);
Who cannot join
- Lack of medical records;
- Failure to complete follow-up;
- Previous coronary artery bypass grafting;
- Severe liver or kidney insufficiency;
- Infectious diseases, malignancies and bleeding diseases;
- OCT image quality was caused by large thrombus volume or residual blood in lumen and percutaneous coronary angiography Poor and further excluded.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation and Treatment Strategy Development of Coronary Heart Disease Guided by Optical Coherence Tomography Based on Multimodal Deep Learning
This is a retrospective, multicenter, observational study aimed at assessing stent apposition for coronary stent implantation by an optical coherence tomography system constructed by deep learning algorithms and evaluating the prognosis of patients after stent implantation in conjunction with multimodal diagnostic and therapeutic information.
Read the detailed description
In this study, we planned to retrospectively collect 2,000 subjects who underwent optical coherence tomography-guided percutaneous coronary stent implantation with an optical coherence tomography system constructed by a deep learning algorithm from 3 centers to assess stent apposition for coronary stent implantation, and to classify subjects into a group with poor stent apposition (axial distance >400 μm or length >1 mm) and a group with good stent apposition. All subjects were followed up within 12 months after the procedure.
- Conditions
- Coronary Disease, Coronary Artery Disease
- Being tested
- Coronary stenting with planned drug eluting stent (DES).
- Medical subject headings
- Coronary Disease, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary stenting with planned drug eluting stent (DES).Procedure or surgery
Stenting will be performed with OCT guidance according to the algorithm described in the protocol. A deep learning-based OCT system was used to measure the adherence of coronary stents.
| Study group | Role | What they receive |
|---|---|---|
| Coronary Stent Malapposition | Measurement results of deep learning-based OCT system: Coronary Stent Malapposition Receives: Procedure: Coronary stenting with planned drug eluting stent (DES). | |
| Coronary Stent Well Apposed | Measurement results of a deep learning-based OCT system: Coronary Stent Well Apposed Receives: Procedure: Coronary stenting with planned drug eluting stent (DES). |
What is being measured
The primary outcome is the main question the study is designed to answer.
MACE
Patients were followed up within 1 year after OCT and PCI. The follow-up included major adverse cardiac events: All causes were death, recurrent myocardial infarction, target vessel reconstruction, and stent thrombosis.
Measured: Post-procedure within 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start20 Aug 2024 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary DiseaseStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiang Ma
- Sponsor type
- University, hospital or other
- Collaborators
- Shihezi University
- Responsible party
- Sponsor-investigator, Xiang Ma, First Affiliated Hospital of Xinjiang Medical University
- Investigators
- Pengfei Liu, M.D, Principal investigator, First Affiliated Hospital of Xinjiang Medical UniversityXinliang Peng, M.D, Principal investigator, First Affiliated Hospital of Xinjiang Medical UniversityAbudusalamu Tuerdimaimaiti, M.D, Principal investigator, First Affiliated Hospital of Xinjiang Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06544681
- Sponsor's protocol ID
- 2022B03022-3
- Status last verified
- Aug 2024
- First submitted
- 5 Aug 2024
- Last updated
- 9 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation and Treatment Strategy Development of Coronary Heart Disease Guided by Optical Coherence Tomography Based on Multimodal Deep Learning
- ClinicalTrials.gov ID
- NCT06544681
- Acronym / sponsor ID
- 2022B03022-3
- Conditions
- Coronary Disease, Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Xiang MaUniversity, hospital or other
- Collaborators
- Shihezi University
- Study start
- 20 Aug 2024 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 9 Aug 2024 (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.
This is a retrospective, multicenter, observational study aimed at assessing stent apposition for coronary stent implantation by an optical coherence tomography system constructed by deep learning algorithms and evaluating the prognosis of patients after stent implantation in conjunction with multimodal diagnostic and therapeutic information.
Detailed description
In this study, we planned to retrospectively collect 2,000 subjects who underwent optical coherence tomography-guided percutaneous coronary stent implantation with an optical coherence tomography system constructed by a deep learning algorithm from 3 centers to assess stent apposition for coronary stent implantation, and to classify subjects into a group with poor stent apposition (axial distance >400 μm or length >1 mm) and a group with good stent apposition. All subjects were followed up within 12 months after the procedure.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coronary Stent Malapposition | – | Procedure: Coronary stenting with planned drug eluting stent (DES).Measurement results of deep learning-based OCT system: Coronary Stent Malapposition |
| Coronary Stent Well Apposed | – | Procedure: Coronary stenting with planned drug eluting stent (DES).Measurement results of a deep learning-based OCT system: Coronary Stent Well Apposed |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Retrospective data were collected from the First Affiliated Hospital of Xinjiang Medical University and Jining, Shandong Province from 2015 to 2022 Coronary artery disease patients undergoing coronary angiography and OCT examination in the First People's Hospital of China and Xigu District People's Hospital of Gansu Province.
Key inclusion criteria (3 listed)
- Age ≥20 years old;
- Angiography was performed, and OCT imaging of criminal blood vessels was performed before intervention;
- Type of coronary heart disease: Unstable angina pectoris (UA), ST elevation myocardial infarction (STEMI) And non-ST elevation myocardial infarction (NSTEMI);
Key exclusion criteria (6 listed)
- Lack of medical records;
- Failure to complete follow-up;
- Previous coronary artery bypass grafting;
- Severe liver or kidney insufficiency;
- Infectious diseases, malignancies and bleeding diseases;
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 |
|---|---|---|
| Coronary stenting with planned drug eluting stent (DES).Stenting will be performed with OCT guidance according to the algorithm described in the protocol. A deep learning-based OCT system was used to measure the adherence of coronary stents. | Procedure or surgery | Coronary Stent Malapposition, Coronary Stent Well Apposed |
Primary outcome
MACE
Time frame: Post-procedure within 1 year
Patients were followed up within 1 year after OCT and PCI. The follow-up included major adverse cardiac events: All causes were death, recurrent myocardial infarction, target vessel reconstruction, and stent thrombosis.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
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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.
Pengfei Liu, M.D principal investigator
First Affiliated Hospital of Xinjiang Medical University
Xinliang Peng, M.D principal investigator
First Affiliated Hospital of Xinjiang Medical University
Abudusalamu Tuerdimaimaiti, M.D principal investigator
First Affiliated Hospital of Xinjiang Medical University
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Disease and Coronary Artery Disease, run by Xiang Ma.
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 3 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: opening soon, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiang Ma, Ph.D (+86 13669939349, maxiangxj@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MACE (time frame: Post-procedure within 1 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 9 Aug 2024.