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Recruiting NCT07312318

AI-Driven Dynamic Prediction of Non-Target Lesion Progression After PCI: A Chinese Multicenter Cohort Study

— Observational Coronary Heart Disease (CHD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: percutaneous coronary intervention.
Who it may be relevant to
Registry conditions: Coronary Heart Disease (CHD). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

DeVelopment of an Artificial Intelligence-Driven Dynamic Prediction and Precision Stratification System for Coronary Non-Target LesIon ProgressiON After Percutaneous Coronary Intervention: A Multimodal Data-Enabled Multicenter Cohort Study in China

Overview

Coronary artery disease remains a leading cause of global mortality. Although percutaneous coronary intervention (PCI) improves patient outcomes, the long-term risk of major adverse cardiovascular events (MACE) driven by the progression of non-target lesions (NTLs) remains substantial and continues to increase, while current risk stratification tools remain inadequate for predicting NTL progression. This multicenter cohort study aims to develop an artificial intelligence (AI)-driven system for the dynamic prediction and precision stratification of NTL progression after PCI. Utilizing comprehensive multimodal data from 52,577 Chinese patients-including clinical profiles, multi-omics blood biomarkers, and coronary imaging-the research pursues three primary objectives: (1) to identify and validate 2-3 specific biomarkers for NTL progression risk using multi-omics approaches; (2) to construct an integrated risk assessment and early-warning system by applying machine learning to multimodal data for predicting NTL progression and MACE; and (3) to establish metabolic and imaging-based subtypes to create a precision management system that optimizes secondary prevention strategies by identifying specific high-risk populations. This study is expected to provide a novel tool for accurate identification of high-risk patients and personalized post-PCI management, ultimately aiming to improve long-term prognosis.

Interventions

  • Other percutaneous coronary intervention
    Percutaneous coronary intervention (PCI) represents a cornerstone therapeutic approach for coronary artery disease. This minimally invasive procedure involves vascular access typically through the radial or femoral artery, enabling the navigation of catheters and specialized devices to the culprit coronary lesion. The primary objective is to restore optimal coronary blood flow by addressing the obstructive lesion. The intervention encompasses various techniques including balloon angioplasty, ste

Primary outcome measures

  • Composite endpoint of NTL progression-related myocardial infarction or revascularization [Time frame: 12 month follow-up]
Secondary outcome measures (4)
  • Qualitative data on NTL progression [Time frame: 12 month follow-up]
  • Quantitative data on NTL progression [Time frame: 12 month follow-up]
  • NTL progression-related myocardial infarction [Time frame: 12 month follow-up]
  • NTL progression-related revascularization [Time frame: 12 month follow-up]

Eligibility criteria

Inclusion criteria

  • Aged 18 years or older;
  • Scheduled for or having undergone PCI;
  • Baseline plasma sample obtainable;
  • Informed consent obtained

Exclusion criteria

  • Pregnancy or lactation;
  • Severe hepatic or renal dysfunction;
  • Active autoimmune disease;
  • Missing critical data

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • China-Japan Friendship Hospital — Beijing

Identifiers

NCT: NCT07312318 · 2025-NHLHCRF-PY-07

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗