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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis of Coronary Artery Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Percutaneous Coronary Intervention (PCI) Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fuwai Hospital, Chinese Academy of Medical Sciences, Beijing, Beijing Municipality, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

CCTA-derived Plaque Quantification

Diagnostic Test

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

Primary outcomes

Major adverse cardiovascular events (MACE)

Time frame: From the date of PCI until December 2024 (minimum 2-year follow-up)

Composite of cardiovascular death, non-fatal myocardial infarction, repeat revascularization, and hospitalization for unstable angina.

Sponsors and collaborators

Lead sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Other

Registry information

Official study title

Imaging Markers of High-Risk Plaque Phenotype for Predicting Post-PCI Outcomes (IMPACT-PCI) Study: A Multicenter Cohort Study Based on Coronary CT Angiography

Acronym: IMPACT-PCI

Important dates

Study start: 2021
Primary completion: 2024
Study completion: 2025
First posted: Aug 12, 2025
Registry last updated: Aug 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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