Three-dimensional Quantitative Flow Ratio (3D-QFR) in Non-selected Angiographic Stenosis. A Spanish Multicentre Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 803
- 主要终点
- To define the functional index of revascularized and non-revascularized coronary stenosis and to analyse the prognosis according to the result and the treatment performed.
研究概览
简要总结
Physiology-based decision-making about the need for revascularisation in patients with stable coronary heart disease has consistently proven better clinical outcomes than a merely anatomical approach. However, against the current recommendations, revascularisation in most of patients with chronic coronary syndromes still relies on coronary angiography alone. The increase in costs and in procedural complexity of wire-based physiology may explain the latter. Therefore, a novel non-invasive functional quantitative flow ratio (QFR) index was created in order to solve it.
A retrospective and multicentre study is performed to assess the 5-year prognosis of patients undergoing coronary angiography through a centralized QFR analysis. Consecutive participants with confirmed or suspected diagnosis of stable coronary disease who underwent a coronary angiography between 01/01/2015 and 12/31/2015 were included.
Aims of the study:
- To evaluate the prognosis of stable coronary disease depending on the functional assessment of coronary artery disease.
- To determine the % of percutaneous coronary interventions that could be avoided if this study had been carried out through functional assessment of coronary artery disease based on 3-dimensional vessel reconstruction.
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
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consecutive participants with confirmed or suspected diagnosis of stable coronary disease who underwent a coronary angiography between 01/01/2015 and 12/31/2015.
排除标准
- •Previous coronary artery bypass grafting.
- •<18 years or >90 years.
- •Angiographic acquisitions that make it impracticable to perform QFR analysis (patients will be included for descriptive purposes).
- •If a patient has undergone several unscheduled coronary angiographies during the study period, the first will be included as the index case and the following as a follow-up event.
结局指标
主要结局
To define the functional index of revascularized and non-revascularized coronary stenosis and to analyse the prognosis according to the result and the treatment performed.
时间窗: 5 years.
To assess the 5-year prognosis of patients undergoing coronary angiography with confirmed or suspected diagnosis of stable coronary disease.
时间窗: 5 years.
To determine number of percutaneous coronary intervention procedures performed on non-significant stenosis through QFR analysis and their prognosis.
时间窗: 5 years.
To evaluate the prognosis of non-revascularized and functionally significant coronary artery disease using QFR.
时间窗: 5 years.
次要结局
未报告次要终点
研究者
Pablo Manuel Fernandez Corredoira
Cardiology resident
Hospital Miguel Servet