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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorLiu Qiang

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

600 Participants
are grouped into 1 trial group
Group A: Adults post-coronary revascularization.

Trial outcomes

Primary outcomes

1

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.

Time frame
12, 24, 36, and 48 weeks post-enrollment

Secondary outcomes

1

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

Time frame
Baseline, 12, 24, 36, 48 weeks post-enrollment
2

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

Time frame
12, 24, 36, 48 weeks post-enrollment
3

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

Time frame
Baseline
4

Left Ventricular End-Diastolic Diameter (LVEDD)

Diameter of the left ventricle at end-diastole, measured by echocardiography. Unit of Measure: mm.

Time frame
Baseline

Other outcomes

Locations

This trial has no 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: