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

NCT07117084 | Active Not Recruiting

• 2 other identifiers: IMPACT-PCI study2024-2586
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Major adverse cardiovascular events (MACE)

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

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

Study Arms (1)

CCTA-PCI Cohort

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

Diagnostic Test: CCTA-derived Plaque Quantification

Interventions

CCTA-derived Plaque Quantification DIAGNOSTIC_TEST

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

CCTA-PCI Cohort

Eligibility Criteria

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

Study Population

Patients who underwent clinically indicated PCI within 30 days after coronary CT angiography.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese Academy of Medical Sciences, Fuwai Hospital: lead

Study Sites (3)

Fuwai Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100037, China

Location

Tai'an Central Hospital

Tai’an, Shandong, 271000, China

Location

Weifang People's Hospital

Weifang, Shandong, 261000, China

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Bin Lu, MD

  Chinese Academy of Medical Sciences, Fuwai Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 5, 2025
• First Posted: August 12, 2025
• Study Start: January 1, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 1, 2025
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)