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

NCT07613060 | Not Yet Recruiting DMC

• 1 other identifier: ZSLL-KY-2026-027-01
• Study Type: observational
• Target: 600
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Coronary Artery Disease; Postoperative Period; Myocardial Revascularization

Outcome Measures

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.

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

Secondary Outcomes (19)

• Traditional Chinese Medicine (TCM) Syndrome Score

  Baseline, 12, 24, 36, 48 weeks post-enrollment

• NYHA Functional Class

  12, 24, 36, 48 weeks post-enrollment

• Multi-omics Biomarkers (exploratory)

  Baseline

• Left Ventricular End-Diastolic Diameter (LVEDD)

  Baseline

• Left Ventricular End-Systolic Diameter (LVESD)

  Baseline

Study Arms (1)

Adults post-coronary revascularization.

Patients aged ≥18 years who underwent coronary revascularization (PCI or CABG). Consecutive enrollment from 5 Chinese hospitals. Prospective follow-up at 12, 24, 36, and 48 weeks post-enrollment. Assessments include MACE (all-cause death, stent thrombosis, myocardial infarction, unstable angina, repeat revascularization, rehospitalization), TCM syndrome score, NYHA class, echocardiography, ambulatory ECG, and biospecimens (blood and tongue coating for proteomics, metabolomics, microbiomics). No intervention is assigned.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Liu Qiang: lead

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood (for proteomics and metabolomics) and tongue coating swabs (for 16S rRNA sequencing/microbiomics). Samples will be retained for biomarker analysis and may be stored for future research related to coronary artery disease and traditional Chinese medicine.

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Central Study Contacts

Liu Qiang

CONTACT

13588121905; 19981011@zcmu.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 15, 2026
• First Posted: May 29, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 29, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share