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临床试验/NCT03935542
NCT03935542已完成不适用

Anatomical Attributes of Clinically Relevant Diagonal Branches in Patients With Left Anterior Descending Coronary Artery Bifurcation Lesions

Bon-Kwon Koo1 个研究点 分布在 1 个国家目标入组 355 人开始时间: 2015年8月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
355
试验地点
1
主要终点
Area under the curve of prediction model

研究概览

简要总结

This study was performed to investigate the anatomical attributes that determine myocardial territory of diagonal branches and to develop a prediction model for clinically relevant branches using myocardial perfusion imaging (MPI) and coronary CT angiography (CCTA).

详细描述

Bifurcation lesion is one of the most challenging lesion subsets in the field of percutaneous coronary intervention (PCI). Despite the recent advances in PCI techniques and stent technology, most randomized studies failed to prove the superiority of systematic 2 stenting strategy compared with provisional side branch intervention strategy.

A certain amount of ischemic burden is required to achieve the benefit of revascularization over medical treatment. Compared with major epicardial vessels, side branches are smaller, more variable in anatomy, supplying less myocardium and less clinically relevant. Therefore, it is important to assess the myocardial mass at risk of side branches to determine the appropriate treatment strategy for bifurcation lesions. However, how to define the clinically relevant side branches which can be associated with the benefit of revascularization in a cardiac catheterization laboratory is not well-known.

The investigators performed this study to investigate the anatomical attributes that determine ischemic burden and myocardial territory of diagonal branches and to develop a prediction model for a clinically relevant diagonal branch using myocardial perfusion imaging (MPI) and coronary CT angiography (CCTA).

研究设计

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

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with severe jailed diagonal branch disease with available MPI in 3 months (MPI arm)
  • Patients who had available FMM value of diagonal branches from a previous multicenter prospective CCTA registry (CCTA arm)

排除标准

  • Patients with >50% stenosis at left anterior descending coronary artery (LAD) or left circumflex artery (LCx), regional wall motion abnormality at LAD territory (MPI arm)
  • Patients with diffuse diagonal branch disease (CCTA arm)

结局指标

主要结局

Area under the curve of prediction model

时间窗: through study completion, an average of 1year

Prediction model using anatomical attributes to define clinical relevance of diagonal branches will be developed.

Positive predictive value of prediction model

时间窗: through study completion, an average of 1year

Prediction model using anatomical attributes to define clinical relevance of diagonal branches will be developed.

Specificity of prediction model

时间窗: through study completion, an average of 1year

Prediction model using anatomical attributes to define clinical relevance of diagonal branches will be developed.

Negative predictive value of prediction model

时间窗: through study completion, an average of 1year

Prediction model using anatomical attributes to define clinical relevance of diagonal branches will be developed.

Angiographic attributes for diagonal branches

时间窗: through study completion, an average of 1year

Angiographic attributes for diagonal branches were visually defined as follows : 1. Size was a binary attribute of vessel diameter ≥ 2.5mm or \< 2.5mm. 2. Number was counted as one, two, and 3 or more diagonal branches. 3. Dominancy in patients with 2 diagonal branches (D1/2 dominancy) was a binary attribute for one of two diagonal branches whose diameter was more than two times larger than its smaller counterpart. 4. LCx dominancy was defined as a left-dominant system or a presence of obtuse marginal branch originating within proximal 1/3 of LCx and crossing LAD at right anterior oblique caudal view.

Sensitivity of prediction model

时间窗: through study completion, an average of 1year

Prediction model using anatomical attributes to define clinical relevance of diagonal branches will be developed.

Accuracy of prediction model

时间窗: through study completion, an average of 1year

Prediction model using anatomical attributes to define clinical relevance of diagonal branches will be developed.

次要结局

  • %FMM(through study completion, an average of 1year)
  • %Ischemia(through study completion, an average of 1year)

研究者

发起方
Bon-Kwon Koo
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Bon-Kwon Koo

Professor

Seoul National University Hospital

研究点 (1)

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