PCCT-Defined High-Risk Plaque and Future Coronary Events: The PREDICT Study

NCT07822737 | Recruiting DMC

• 1 other identifier: 2025-ke-1040
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective cohort study aims to determine whether high-risk coronary plaques identified by novel Photon-Counting Detector CT (PCCT) independently predict future major adverse cardiovascular events (MACE). Participants will be followed for MACE and revascularization. The primary hypothesis is that the incidence of MACE is significantly higher in patients with PCCT-defined high-risk plaque than in those without. Additionally, patients will undergo Optical Coherence Tomography (OCT) and angiography within a month after PCCT; PCCT results will be compared with OCT in a cross-sectional analysis, and diagnostic performance will be evaluated against follow-up data.

Conditions

Coronary Artery Disease; Plaque; Photon-Counting Computed Tomography

Keywords

Photon-Counting Computed Tomography; Coronary Artery Disease; High risk plaque

Outcome Measures

Primary Outcomes (1)

• Incidence of major adverse cardiovascular events (MACE)

  Incidence of major adverse cardiovascular events (MACE), defined as a composite of cardiovascular death, non-fatal myocardial infarction, and hospitalization for unstable angina requiring urgent revascularization, stratified by the presence versus absence of PCCT-defined high-risk plaque.

  Up to 24 months

Secondary Outcomes (2)

• Per-lesion MACE

  Up to 24 months

• Myocardial infarction

  Up to 24 months

Other Outcomes (1)

• Diagnostic accuracy of PCCT for detecting OCT-defined high-risk plaque

  up to 12 month

Study Arms (2)

PCCT High-Risk Plaque Group

Participants with PCCT-defined high-risk plaque in at least one native coronary artery. High-risk plaque is defined as the presence of ≥2 of the following features on PCCT: low-attenuation plaque (\<30 Hounsfield Units), positive remodeling (remodeling index ≥1.1), spotty calcification (\<3 mm), and the napkin-ring sign.

PCCT Non-High-Risk Plaque Group

Participants without PCCT-defined high-risk plaque (0 or 1 high-risk feature) in any imaged coronary segment.

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

Patient with coronary artery disease

You may qualify if:

• Age ≥18 years
• Scheduled for clinically indicated, non-emergent invasive coronary angiography
• Provision of written informed consent and willingness to comply with long-term follow-up

You may not qualify if:

• Estimated glomerular filtration rate \<45 mL/min/1.73 m²
• Known allergy to iodinated contrast media
• Pregnancy or breastfeeding
• Persistent atrial fibrillation or other arrhythmia precluding adequate ECG-gated CT acquisition
• Body mass index \>40 kg/m²
• Target vessel with a previously implanted stent
• Life expectancy \<2 years or any condition that, in the opinion of the investigator, makes follow-up unlikely or participation inappropriate

Sponsors & Collaborators

• Beijing Chao Yang Hospital: lead

Study Sites (1)

Beijing Chaoyang Hospital，Capital Medical University, Beijing

Beijing, China, 10000, China

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease; Plaque, Amyloid

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Bin Tu, MD.PhD

CONTACT

+8618810682692; dr_bintu@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of the Cardia department

Study Record Dates

• First Submitted: July 12, 2026
• First Posted: September 16, 2026
• Study Start: January 18, 2025
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): December 30, 2030
• Last Updated: September 16, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)