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Bern Intracoronary Optical Coherence Tomography and Coronary Computed Tomography Angiography Registry (BIOCORE)

2026年5月7日更新者：Insel Gruppe AG, University Hospital Bern

Bern Intarcoronary Optical Coherence Tomography and Coronary Computed Tomography Angiography Registry

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.

研究概览

地位

招聘中

条件

冠状动脉疾病 (CAD)

详细说明

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.

研究类型

观察性的

注册 (估计的)

816

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

姓名：Sarah Bär, MD, PhD
电话号码：+41316322111
邮箱：sarah.baer@insel.ch

研究联系人备份

姓名：Räber Lorenz, Prof. MD PhD
电话号码：+41316322111
邮箱：lorenz.raeber@insel.ch

学习地点

瑞士
- - Bern、瑞士、3010
    - 招聘中
    - Department of Cardiology, Bern University Hospital Inselspital
    - 接触：
      
      Sarah Bär, MD-PhD
      
      电话号码：+41316322111
      
      邮箱：sarah.baer@insel.ch
    - 接触：
      
      Lorenz Räber, Prof. MD-PhD
      
      电话号码：+41316322111
      
      邮箱：lorenz.raeber@insel.ch
    - 首席研究员：
      
      Lorenz Räber, Prof. MD-PhD
    - 副研究员：
      
      Sarah Bär, MD-PhD
    - 副研究员：
      
      Christoph Gräni, Prof. MD-PhD

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

孩子
成人
年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

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

描述

Inclusion Criteria:

≥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)

Exclusion Criteria:

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

团体/队列数

队列和干预

团体/队列
Patients undergoing paired CCTA and OCT Patients undergoing CCTA and invasive coronary angiography with OCT within 3 months

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Diagnostic accuracy in plaque phenotyping CCTA vs. OCT 大体时间：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)	Baseline
PCI planning with CCTA vs. gold standard OCT 大体时间：Baseline	Diagnostic accuracy of CCTA in identifying the need for PCI and agreement in stent sizing	Baseline
Photon-counting vs. conventional CCTA 大体时间：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)	Baseline

其他结果措施

结果测量	措施说明	大体时间
Clinical outcomes throughout 1 and 5 years 大体时间：1 and 5 years follow-up	All-cause death Cardiovascular death Myocardial infarction Unstable angina pectoris Clinically-driven coronary revascularization Stent thrombosis In-stent-restenosis	1 and 5 years follow-up

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Insel Gruppe AG, University Hospital Bern

调查人员

学习椅：Lorenz Räber, Prof. MD-PhD、Department of Cardiology, Bern University Hospital Inselspital, Switzerland
首席研究员：Sarah Bär, MD-PhD、Department of Cardiology, Bern University Hospital Inselspital, Switzerland
首席研究员：Christoph Gräni, Prof. MD-PhD、Department of Cardiology, Bern University Hospital Inselspital, Switzerland

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年10月17日

初级完成 (估计的)

2028年12月31日

研究完成 (估计的)

2033年12月31日

研究注册日期

首次提交

2026年4月27日

首先提交符合 QC 标准的

2026年4月27日

首次发布 (实际的)

2026年5月4日

研究记录更新

最后更新发布 (实际的)

2026年5月12日

上次提交的符合 QC 标准的更新

2026年5月7日

最后验证

2026年5月1日