About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of coronary artery disease with prior coronary revascularization (PCI or CABG)
Age ≥ 18 years
Signed informed consent
Disqualifiers
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
Trial population
Adult patients (≥18 years) who have undergone coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) for coronary artery disease. Participants are recruited consecutively from the cardiology wards and outpatient clinics of three tertiary hospitals in China, including The Third Affiliated Hospital of Zhejiang Chinese Medical University (lead site), Zhejiang Provincial People's Hospital, The First Affiliated Hospital of Zhejiang Chinese Medical University.
Trial design
Cohort
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Major Adverse Cardiovascular Events (MACE)
Composite of all-cause death, subacute stent thrombosis, perioperative myocardial infarction, recurrent myocardial infarction, recurrent unstable angina, repeat revascularization (PCI or CABG), and rehospitalization due to angina or heart failure. Events are ascertained by medical records, clinical diagnosis, coronary angiography, ECG, and cardiac enzyme/troponin measurements.
Secondary outcomes
Traditional Chinese Medicine (TCM) Syndrome Score
Total score of TCM symptoms and signs (chest pain, palpitations, fatigue, tongue/pulse, etc.). Each item scored 0-3 (none to severe). Sum of all items. Higher score indicates more severe symptoms. Unit of Measure: points on a scale
NYHA Functional Class
Classification of heart failure symptoms based on physical activity limitation. Class I (no limitation) to IV (symptoms at rest). Unit of Measure: relative abundance / qualitative
Multi-omics Biomarkers (exploratory)
Proteomics, metabolomics (LC-MS/MS, LC-MS/GC-MS) from blood, and 16S rRNA microbiome from tongue coating. Used to identify biomarkers associated with TCM patterns. Results reported as relative abundance or presence/absence. Unit of Measure: relative abundance / qualitative
Left Ventricular End-Diastolic Diameter (LVEDD)
Diameter of the left ventricle at end-diastole, measured by echocardiography. Unit of Measure: mm.
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Liu Qiang
Lead sponsor
The Third Affiliated hospital of Zhejiang Chinese Medical University
Sponsor institution
This trial is not recruiting at the moment. You can still explore other options: