Coronary Heart Disease (CHD)VISION-PCINCT07312318
AI-Driven Dynamic Prediction of Non-Target Lesion Progression After PCI: A Chinese Multicenter Cohort Study
An observational study of Coronary Heart Disease (CHD), run by China-Japan Friendship Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Heart Disease (CHD)
- What is being tested?
- percutaneous coronary intervention
- How many people
- 12,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2025to 31 Aug 2026
- How long will I take part?
- 12 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Aged 18 years or older;
- Scheduled for or having undergone PCI;
- Baseline plasma sample obtainable;
- Informed consent obtained
Who cannot join
- Pregnancy or lactation;
- Severe hepatic or renal dysfunction;
- Active autoimmune disease;
- Missing critical data
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
Fang Wang, +86 13683173633, wangfang@cjfh.org.cn
About this study
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
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)
- Being tested
- percutaneous coronary intervention
- Keywords
- Artificial Intelligence, Non-Target LesIon Progression, Percutaneous Coronary Intervention, coronary heart disease
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
percutaneous coronary interventionOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite endpoint of NTL progression-related myocardial infarction or revascularization
- 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.
- 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.
Measured: 12 month follow-up
Secondary outcomes (4)
Qualitative data on NTL progression
The following conditions are defined as NTL progression: (1) NCL stenosis ≥50% at baseline PCI with ≥10% NCL progression at angiographic follow-up; (2) NCL stenosis <50% at baseline PCI with ≥30% NCL progression at angiographic follow-up; (3) NCL progression ≥30% without NCL at baseline PCI; (4) NCL progression to complete occlusion. Quantitative data for NTL progression (QCA) are obtained by analyzing coronary angiographic images to determine lesion progression.
Measured: 12 month follow-up
Quantitative data on NTL progression
QCA analyzes coronary angiography images to determine the progression of lesions: Coronary angiography was evaluated by two independent cardiologists who were unaware of all other clinical data of the patients, using the MEDCON TCS QCA software. First, the edges of the contrast-enhanced vessels were delineated using an automatic edge detection algorithm. After identifying the starting and ending points on the enhanced coronary images, a vascular path was created. Subsequently, the vessel contour was drawn along the path. The path and vessel contour were automatically determined based on contrast density, with occasional manual editing required by the analysts. Measured variables included minimum lumen diameter and degree of lumen stenosis (minimum lumen diameter/adjacent contrast vessel diameter).
Measured: 12 month follow-up
NTL progression-related myocardial infarction
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.
Measured: 12 month follow-up
NTL progression-related revascularization
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.
Measured: 12 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2025
- Study start1 Sep 2025
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart Disease (CHD)Studies of the same condition, open and under way.
- More trials run by China-Japan Friendship HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 12,000 participants (estimated)
- Target duration
- 12 Years
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking Union Medical College
- Responsible party
- Principal investigator, Fang Wang, China-Japan Friendship Hospital
- Investigators
- Fang Wang, Principal investigator, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07312318
- Sponsor's protocol ID
- 2025-NHLHCRF-PY-07
- Acronym
- VISION-PCI
- Status last verified
- Dec 2025
- First submitted
- 3 Dec 2025
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07312318
- Acronym / sponsor ID
- VISION-PCI / 2025-NHLHCRF-PY-07
- Conditions
- Coronary Heart Disease (CHD)
- Keywords
- Artificial Intelligence, Non-Target LesIon Progression, Percutaneous Coronary Intervention, coronary heart disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 12,000 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Collaborators
- Peking Union Medical College
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 31 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 12 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Aged 18 years or older;
- Scheduled for or having undergone PCI;
- Baseline plasma sample obtainable;
- Informed consent obtained
Key exclusion criteria (4 listed)
- Pregnancy or lactation;
- Severe hepatic or renal dysfunction;
- Active autoimmune disease;
- Missing critical data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| percutaneous coronary interventionPercutaneous 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. | Other | – |
Primary outcome
Composite endpoint of NTL progression-related myocardial infarction or revascularization
Time frame: 12 month follow-up
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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fang Wang principal investigator
China-Japan Friendship Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Heart Disease (CHD), run by China-Japan Friendship Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fang Wang (+86 13683173633, wangfang@cjfh.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite endpoint of NTL progression-related myocardial infarction or revascularization (time frame: 12 month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2025.