The Heartflow Coronary Disease Progression Evaluation Study
试验速览
- 阶段
- 不适用
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Coronary atherosclerotic disease progression
研究概览
简要总结
Invasively measured fractional flow reserve (FFR) has proven to be useful in guiding coronary revascularization. Several studies have shown that it is justified to treat lesions with a value of 0.80 or lower and safe to defer from PCI in lesions with a value of >0.80. Recently, computational fluid dynamics have allowed FFR measurement from coronary computed tomography angiography images (FFRCT) with excellent diagnostic accuracy compared to invasive FFR.
FFRCT can also effectively guide revascularization safely deferring patient with FFRCT >0.80 from invasive angiography. In functionally non-significant lesions, computational fluid dynamic models in addition to CT plaque characteristics (low attenuation, positive remodelling, spotty calcification and napkin-ring sign) may be able to predict which lesions will become flow-limiting, causing clinical events in the future.
This study will evaluate disease progression in intermediate lesions (invasive FFR 0.81-0.90 at baseline) using FFRCT at 2 years and determine whether CT characteristics may help to identify lesions that are more susceptible for FFR decline. Additionally, we will correlate CT characteristics with coronary events (a composite endpoint consisting of all-cause mortality, target-vessel myocardial infarction and clinically driven target-vessel revascularization) up to 5 years after the baseline invasive FFR.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients (age ≥ 18 years) treated with PCI (for non-ST elevation myocardial infarction, unstable or stable angina and silent ischemia) or who undergo invasive FFR.
- •Minimum of one non-treated coronary artery with an intermediate lesion and invasive FFR 0.81-0.90 to serve as the target vessel for FFRCT.
排除标准
- •ST elevation myocardial infarction.
- •Previous CABG.
- •Target vessel for FFR measurement < 2.0 mm in diameter.
- •Contraindications to contrast agents, beta-blocking agents, nitroglycerin or adenosine.
- •Life expectancy less than 3 years.
- •Creatinine clearance < 30 ml/min*1.73m2.
结局指标
主要结局
Coronary atherosclerotic disease progression
时间窗: 2 years
FFRCT
次要结局
- Target lesion failure Target vessel failure(3-5 years)
- Any coronary revascularisation(3-5 years)
研究者
Nicolas van Mieghem
Director of Interventional Cardiology
Erasmus Medical Center
