Bern Intarcoronary Optical Coherence Tomography and Coronary Computed Tomography Angiography Registry
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
- 否
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
