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

NCT ID: NCT07312318

Last Updated: 2025-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

12000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-01

Study Completion Date

2026-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Coronary Heart Disease (CHD)

Keywords

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Interventions

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Aged 18 years or older;
2. Scheduled for or having undergone PCI;
3. Baseline plasma sample obtainable;
4. Informed consent obtained

Exclusion Criteria

1. Pregnancy or lactation;
2. Severe hepatic or renal dysfunction;
3. Active autoimmune disease;
4. Missing critical data
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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China-Japan Friendship Hospital

OTHER

Sponsor Role lead

Peking Union Medical College

OTHER

Sponsor Role collaborator

Responsible Party

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Fang Wang

Associate Professor of Cardiology Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fang Wang

Role: PRINCIPAL_INVESTIGATOR

China-Japan Friendship Hospital

Locations

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China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Fang Wang

Role: CONTACT

Phone: +86 13683173633

Email: [email protected]

Facility Contacts

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Fang Wang

Role: primary

Other Identifiers

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2025-NHLHCRF-PY-07

Identifier Type: -

Identifier Source: org_study_id