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

NCT07312318 | Recruiting DMC

• 1 other identifier: 2025-NHLHCRF-PY-07
• Study Type: observational
• Target: 12,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Heart Disease (CHD)

Keywords

Artificial Intelligence; Non-Target LesIon Progression; Percutaneous Coronary Intervention; coronary heart disease

Outcome Measures

Primary Outcomes (1)

• Composite endpoint of NTL progression-related myocardial infarction or revascularization

  1. NTL progression-related myocardial infarction was defined in accordance with the fourth universal definition of myocardial infarction due to any segment of the nontarget vessel or lesion. 2. NTL progression-related revascularization was defined as revascularization driven by angina or ischemia, either PCI or CABG, of any segment of the nontarget vessel or lesion.

  12 month follow-up

Secondary Outcomes (4)

• Qualitative data on NTL progression

  12 month follow-up

• Quantitative data on NTL progression

  12 month follow-up

• NTL progression-related myocardial infarction

  12 month follow-up

• NTL progression-related revascularization

  12 month follow-up

Interventions

percutaneous coronary intervention OTHER

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, stent implantation, and adjunctive procedures such as coronary atherectomy and thrombus aspiration when clinically indicated.

Eligibility Criteria

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

Study Population

The study integrates three dedicated Chinese cohorts of post-PCI coronary artery disease patients, comprising two cohorts provided by the National Population Health Data Center and one consecutive cohort recruited from the Department of Cardiology at China-Japan Friendship Hospital.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• China-Japan Friendship Hospital: lead
• Peking Union Medical College: collaborator

Study Sites (1)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Collect 4 ml of fasting peripheral venous blood from enrolled patients. Fasting should commence at 22:00 the day before blood collection. The blood should be placed in EDTA anticoagulant tubes. Within 2 hours after blood collection, plasma should be separated and stored for subsequent lipidomic analysis. This involves centrifuging at 3000 rpm for 10 minutes to separate the plasma. Transfer the upper layer of plasma into 200 ul/1.5 ml EP tubes, then store at -80°C for preservation

MeSH Terms

Conditions

Coronary Disease

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Fang Wang

  China-Japan Friendship Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fang Wang

CONTACT

+86 13683173633; wangfang@cjfh.org.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 12 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Cardiology Department

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: December 31, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: December 31, 2025

Record last verified: 2025-12

Locations

CN (1)