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
Visão geral do estudo
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Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Bin Tu, MD.PhD
- Número de telefone: +8618810682692
- E-mail: dr_bintu@163.com
Locais de estudo
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China
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Beijing, China, China, 10000
- Recrutamento
- Beijing Chaoyang Hospital，Capital Medical University, Beijing
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Contato:
- Bin Tu, MD, PhD
- Número de telefone: +8618810682692
- E-mail: dr_bintu@163.com
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Critérios de participação
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- Adulto
- Adulto mais velho
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Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
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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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Incidence of major adverse cardiovascular events (MACE)
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Per-lesion MACE
Prazo: 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
Prazo: 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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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Diagnostic accuracy of PCCT for detecting OCT-defined high-risk plaque
Prazo: 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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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
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Outros números de identificação do estudo
- 2025-ke-1040
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