Establishment of Disease Characteristics and a Chinese Medicine Prognosis Risk Model Based on a Large-Scale Database After Coronary Revascularization

Establishment of Disease Characteristics and a Chinese Medicine Prognosis Risk Model Based on a Large-Scale Database After Coronary Revascularization

This study aims to develop a risk prediction model for patients who have undergone coronary revascularization (such as stent placement or bypass surgery). After these procedures, some patients still experience heart-related problems like chest pain, heart attack, or rehospitalization. This study will enroll 600 patients from multiple hospitals in China and follow them for 12 months. At enrollment and at 12, 24, 36, and 48 weeks after surgery, researchers will collect clinical information (including traditional Chinese medicine symptoms, blood tests, heart imaging) and biological samples (blood and tongue coating). Using artificial intelligence, the study will build a predictive model that combines Western medical data with traditional Chinese medicine characteristics. The goal is to better identify patients at higher risk of future heart events, so that personalized prevention and management can be provided. The study does not involve any experimental treatment or intervention - it is purely observational.

This is a multicenter, prospective cohort study conducted at five sites in China. The study aims to develop and validate a prognostic risk model for major adverse cardiovascular events (MACE) in patients after coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting).

Study population: A total of 600 eligible patients aged ≥18 years who have undergone coronary revascularization will be enrolled consecutively. Key exclusion criteria include severe heart failure, malignant arrhythmias, severe pulmonary or liver/kidney dysfunction, pregnancy, psychiatric disorders, and poor compliance.

Data collection: At baseline (enrollment), the following data are collected: demographics, medical history, surgical characteristics (e.g., access route, number of stents, target vessels), vital signs, laboratory tests (complete blood count, cardiac enzymes, liver/kidney function, lipids, glucose), echocardiography, 24-hour ambulatory electrocardiography, and a standardized Traditional Chinese Medicine (TCM) case report form covering symptom scores, tongue/pulse findings, and pattern elements. In addition, biological samples (blood and tongue coating) are obtained for proteomics, metabolomics, and tongue-coating microbiomics.

Follow-up: Participants are followed at 12, 24, 36, and 48 weeks post-enrollment. At each follow-up, the TCM case report form is reassessed, MACE (including all-cause death, subacute stent thrombosis, perioperative myocardial infarction, recurrent myocardial infarction, recurrent unstable angina, repeat revascularization, and rehospitalization for angina or heart failure) are recorded, and NYHA functional class and current medications are updated.

Statistical analysis: Missing data will be handled by mean imputation or K-nearest neighbors imputation. Continuous variables will be standardized using Z-scores, and categorical variables will be one-hot encoded. Feature selection will be performed using LASSO regression. Three nested prediction models will be built:

• Model_Base: Cox proportional hazards model based on routine clinical and imaging variables.
• Model_TCM: adding TCM syndrome features using machine learning algorithms (random forest, support vector machine).
• Model_Full: further integrating multi-omics biomarkers using deep learning methods (convolutional neural network, transformer).

Model performance will be assessed by discrimination (area under the ROC curve), calibration, and decision curve analysis. Internal validation will use k-fold cross-validation, and external validation will be conducted in at least three independent hospitals. The targeted predictive accuracy (area under the curve) is above 85%. All analyses will be performed using SPSS 26.0, Python, and R.

Ethics: The study protocol has been approved by the ethics committee of the lead site (The Third Affiliated Hospital of Zhejiang Chinese Medical University) and will be approved by participating centers. Written informed consent will be obtained from all participants.

Inclusion Criteria:

• Diagnosis of coronary artery disease with prior coronary revascularization (PCI or CABG)
• Age ≥ 18 years
• Signed informed consent

Exclusion Criteria:

• Malignant arrhythmias, severe heart failure, myocardial disease, or structural heart disease
• Severe pulmonary insufficiency, severe liver or kidney dysfunction, severe electrolyte disturbances
• Pregnancy or breastfeeding
• Severe psychiatric disorders, malignant tumors, hematologic diseases, rheumatic immune diseases, or severe infection
• Poor compliance or any other reason making the participant unsuitable for the study