跳至主要内容
临床试验/NCT07565805
NCT07565805招募中不适用

Bern Intarcoronary Optical Coherence Tomography and Coronary Computed Tomography Angiography Registry

Insel Gruppe AG, University Hospital Bern1 个研究点 分布在 1 个国家目标入组 816 人开始时间: 2025年10月17日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
816
试验地点
1
主要终点
Diagnostic accuracy in plaque phenotyping CCTA vs. OCT

研究概览

简要总结

Bern Intracoronary Optical Coherence Tomography and Coronary Computed Tomography Angiography Registry (BIOCORE) is a systematic institutional registry on patients undergoing paired CCTA and OCT for validation and development of advanced methods to determine coronary plaque morphology, lesion severity, PCI guidance, and it association with long-term clinical outcomes.

详细描述

Intracoronary imaging represents the current gold standard for in-vivo assessment of plaque morphology and guidance of percutaneous coronary intervention (PCI). However, coronary computed tomography angiography (CCTA) plays an increasingly important role in the diagnostic pathway of CAD and represents a non-invasive procedure with wide availability, relatively low costs, and low radiation dose. Owing to its recent technical advances with the introduction of photon-counting CT with higher spatial resolution and diagnostic accuracy as compared to conventional CCTA, as well as recently developed artificial intelligence (AI)-guided analysis softwares, CCTA has the potential to provide more and more clinically essential information about coronary artery disease (CAD) with respect to plaque composition, lesion severity, need for intervention, and periprocedural planning that has traditionally been restricted to invasive coronary angiography and intracoronary imaging. Therefore, there is a timely need for systematic evaluation of advanced CCTA techniques against invasive gold standards. Furthermore, studies comparing CCTA to optical coherence tomography (OCT), the gold standard for plaque phenotyping, are scarce to date. Also, traditional treatment concepts of CAD that are based on obstructive stenosis and ischemia are currently challenged by an increasing body of evidence demonstrating the prognostic impact of plaque burden and composition independent of flow-limitation. Plaque burden and composition may emerge as the next treatment target in CAD. Therefore, the investigators established a systematic institutional registry on patients undergoing paired CCTA and OCT for validation and development of advanced methods to determine coronary plaque morphology, lesion severity, PCI guidance, and it association with long-term clinical outcomes.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • ≥18 years of age
  • Written informed consent
  • CCTA within 3 months from invasive coronary angiography and OCT
  • At least one vessel with ≥50% diameter stenosis on CCTA
  • OCT performed in native coronary arteries (i.e. pre-PCI or no PCI)

排除标准

  • CCTA performed more than 3 months from OCT
  • Poor OCT quality
  • Poor CCTA quality
  • Coronary anomalies
  • Prior PCI or CABG in the vessel imaged with OCT

研究组 & 干预措施

Patients undergoing paired CCTA and OCT

Patients undergoing CCTA and invasive coronary angiography with OCT within 3 months

结局指标

主要结局

Diagnostic accuracy in plaque phenotyping CCTA vs. OCT

时间窗: Baseline

Proportion of correctly classified plaques quantitative computed tomography (QCT) (low-attenuation, non-calcified, calcified plaques) against the gold standard OCT (lipid-rich, fibrous, fibro-calcific plaque)

PCI planning with CCTA vs. gold standard OCT

时间窗: Baseline

Diagnostic accuracy of CCTA in identifying the need for PCI and agreement in stent sizing

Photon-counting vs. conventional CCTA

时间窗: Baseline

Proportion of correctly classified plaques with photon-counting CCTA vs. conventional CCTA (low-attenuation, non-calcified, calcified plaques) against the gold standard OCT for plaque morphology (lipid-rich, fibrous, fibro-calcific plaque)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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