PCCT-Defined High-Risk Plaque and Future Coronary Events: The PREDICT Study (PREDICT)
Prognostic Value of Photon-Counting Detector CT-Derived High-Risk Coronary Plaque Features for Predicting Major Adverse Cardiovascular Events: a Prospective Cohort Study
Studie Overzicht
Toestand
Gedetailleerde beschrijving
Photon-Counting Detector CT (PCCT) enables improved spatial resolution and spectral tissue characterization, allowing non-invasive detection of high-risk coronary plaque (HRP) features such as low-attenuation plaque (<30 HU), positive remodeling (index ≥1.1), spotty calcification, and the napkin-ring sign. The presence of ≥2 of these features defines a PCCT-detected high-risk plaque. Optical Coherence Tomography (OCT), an invasive high-resolution imaging tool, defines HRP by thin-cap fibroatheroma (fibrous cap thickness <65 μm, lipid arc >90°) and other vulnerable features. While OCT provides detailed information on plaque vulnerability, it is invasive and limited to selected vessels. The prognostic significance of PCCT-defined HRP, and its diagnostic agreement with OCT, remain to be fully established.
This prospective, single-centre study will enroll patients with acute or stable coronary syndromes who are scheduled for clinically indicated invasive coronary angiography and OCT evaluation of at least one native coronary artery. All participants will first undergo a dedicated contrast-enhanced PCCT coronary angiogram. Within 30 days after PCCT, participants will undergo invasive coronary angiography with OCT imaging. Thus, OCT is systematically acquired after the CT, allowing a cross-sectional diagnostic comparison where PCCT findings are evaluated against the OCT reference. Both imaging datasets will be analyzed by independent core laboratories blinded to each other's results and to clinical data.
The study has two integrated components:
- Prognostic component - The primary objective is to assess whether the presence of PCCT-defined HRP independently predicts the 2-year incidence of MACE (cardiovascular death, non-fatal myocardial infarction, hospitalization for unstable angina requiring urgent revascularization). The primary hypothesis is that MACE rate is significantly higher in patients with PCCT-HRP than in those without.
- Cross-sectional diagnostic comparison - Using OCT as the invasive reference, the diagnostic performance of PCCT for identifying high-risk plaque will be determined. Per-patient and per-lesion sensitivity, specificity, positive and negative predictive values, and overall accuracy of PCCT will be calculated and compared with OCT-derived high-risk plaque classification.
Participants will be followed prospectively for MACE and unplanned revascularization over 24 months.
Studietype
Inschrijving (Geschat)
Contacten en locaties
Studiecontact
- Naam: Bin Tu, MD.PhD
- Telefoonnummer: +8618810682692
- E-mail: dr_bintu@163.com
Studie Locaties
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China
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Beijing, China, China, 10000
- Werving
- Beijing Chaoyang Hospital，Capital Medical University, Beijing
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Contact:
- Bin Tu, MD, PhD
- Telefoonnummer: +8618810682692
- E-mail: dr_bintu@163.com
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Bemonsteringsmethode
Studie Bevolking
Beschrijving
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
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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.
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PCCT Non-High-Risk Plaque Group
Participants without PCCT-defined high-risk plaque (0 or 1 high-risk feature) in any imaged coronary segment.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Incidence of major adverse cardiovascular events (MACE)
Tijdsspanne: Up to 24 months
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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.
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Up to 24 months
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Per-lesion MACE
Tijdsspanne: Up to 24 months
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Per-lesion hazard ratio of MACE for PCCT-defined HRP and OCT-defined HRP, adjusted for baseline clinical risk factors
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Up to 24 months
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Myocardial infarction
Tijdsspanne: Up to 24 months
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Time to first non-fatal myocardial infarction
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Up to 24 months
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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Diagnostic accuracy of PCCT for detecting OCT-defined high-risk plaque
Tijdsspanne: up to 12 month
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per-patient and per-lesion sensitivity, specificity, positive predictive value, negative predictive value, and area under the ROC curve
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up to 12 month
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Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2025-ke-1040
Plan Individuele Deelnemersgegevens (IPD)
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Informatie over medicijnen en apparaten, studiedocumenten
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