PCCT-Defined High-Risk Plaque and Future Coronary Events: The PREDICT Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBeijing Chao Yang Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Patient with coronary artery disease
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
500 Participants
are grouped into 2 trial groupsGroup A: PCCT High-Risk Plaque Group
Group B: PCCT Non-High-Risk Plaque Group
Trial outcomes
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.
Time frame
Up to 24 monthsSecondary outcomes
1
Per-lesion MACE
Per-lesion hazard ratio of MACE for PCCT-defined HRP and OCT-defined HRP, adjusted for baseline clinical risk factors
Time frame
Up to 24 months2
Myocardial infarction
Time to first non-fatal myocardial infarction
Time frame
Up to 24 monthsOther outcomes
1
Diagnostic accuracy of PCCT for detecting OCT-defined high-risk plaque
per-patient and per-lesion sensitivity, specificity, positive predictive value, negative predictive value, and area under the ROC curve
Time frame
up to 12 monthSponsors and contacts
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Source ClinicalTrials.gov