Clinical trial NCT06544681: Evaluation and Treatment Strategy Development of Coronary Heart Disease Guided by OCT Based on Multimodal Deep Learning
Official title: Evaluation and Treatment Strategy Development of Coronary Heart Disease Guided by Optical Coherence Tomography Based on Multimodal Deep Learning
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Coronary Disease
Coronary Artery Disease
Lead sponsor: First Affiliated Hospital of Xinjiang Medical University
Sponsor class: OTHER
Collaborators: name: Shihezi University
First posted: 2024-08-09
Enrollment: 2000
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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);

Exclusion Criteria:

* 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.

Primary outcomes:
measure: MACE
timeFrame: Post-procedure within 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: First Affiliated Hospital of Xinjiang Medical University
name: Pengfei Liu, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: First Affiliated Hospital of Xinjiang Medical University
name: Xinliang Peng, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: First Affiliated Hospital of Xinjiang Medical University
name: Abudusalamu Tuerdimaimaiti, M.D
role: PRINCIPAL_INVESTIGATOR
References: