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

Sponsor
Liu Qiang
Study ID
NCT07613060
Status
Not Yet Recruiting

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Conditions

  • Coronary Artery Disease
  • Myocardial Revascularization
  • Postoperative Period

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

First listed
May 29, 2026
Start date
Jul 1, 2026
Status verified
May 2026
Primary completion
Jun 30, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
600 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

Major Adverse Cardiovascular Events (MACE) [ Time Frame: 12, 24, 36, and 48 weeks post-enrollment ]

Central Contacts

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