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Clinical Trials/NCT07117084
NCT07117084Active, not recruitingNot Applicable

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

Chinese Academy of Medical Sciences, Fuwai Hospital3 sites in 1 country2,000 target enrollmentStarted: January 1, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
Enrollment
2,000
Locations
3
Primary Endpoint
Major adverse cardiovascular events (MACE)

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Bin Lu

Principal Investigator

Chinese Academy of Medical Sciences, Fuwai Hospital

Study Sites (3)

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