Imaging Markers of High-Risk Plaque Phenotype for Predicting Post-PCI Outcomes

NCT ID: NCT07117084

Last Updated: 2025-08-12

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

ACTIVE_NOT_RECRUITING

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-01

Study Completion Date

2025-12-31

Brief Summary

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Despite the widespread use of stents, previous studies have shown that stent implantation mainly relieves symptoms but may not significantly improve long-term outcomes in patients with stable coronary artery disease. Identifying the types of plaques that are most likely to benefit from stenting is essential for improving personalized treatment. This study explores whether coronary computed tomography angiography (CCTA)-derived imaging biomarkers of coronary plaques are associated with increased risk of adverse outcomes after percutaneous coronary intervention (PCI). Around 2,000 patients who underwent CCTA followed by stent placement were included. Advanced software was used to quantify plaque inflammation and composition. Findings from this research may help guide personalized treatment strategies in patients undergoing PCI.

Detailed Description

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Conditions

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Coronary Artery Disease Percutaneous Coronary Intervention (PCI) Atherosclerosis of Coronary Artery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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CCTA-PCI Cohort

Patients who underwent coronary CT angiography followed by PCI within 30 days.

CCTA-derived Plaque Quantification

Intervention Type DIAGNOSTIC_TEST

Quantitative analysis of coronary plaque features based on coronary CT angiography using semi-automated software.

Interventions

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CCTA-derived Plaque Quantification

Quantitative analysis of coronary plaque features based on coronary CT angiography using semi-automated software.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

1. patients aged 18 years or older;
2. patients who underwent clinically indicated PCI within 30 days following CCTA;
3. CCTA demonstrating the presence of coronary atherosclerotic plaque.

Exclusion Criteria

1. patients whose PCI within 30 days after CCTA was performed on an emergency basis;
2. elevated cardiac troponin levels within the 3 months preceding PCI;
3. inadequate CCTA image quality;
4. balloon-only or mixed stent/balloon PCI strategies;
5. PCI for non-atherosclerotic lesions (e.g., in-stent restenosis, spontaneous coronary dissection);
6. history of coronary artery bypass grafting;
7. heart failure;
8. non-ischemic cardiomyopathy;
9. significant valvular heart disease;
10. refractory hypertension;
11. persistent atrial fibrillation.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese Academy of Medical Sciences, Fuwai Hospital

OTHER

Sponsor Role lead

Responsible Party

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Bin Lu

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bin Lu, MD

Role: PRINCIPAL_INVESTIGATOR

Chinese Academy of Medical Sciences, Fuwai Hospital

Locations

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Fuwai Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Site Status

Tai'an Central Hospital

Tai’an, Shandong, China

Site Status

Weifang People's Hospital

Weifang, Shandong, China

Site Status

Countries

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China

Other Identifiers

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2024-2586

Identifier Type: OTHER

Identifier Source: secondary_id

IMPACT-PCI study

Identifier Type: -

Identifier Source: org_study_id

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