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临床试验/NCT04052256
NCT04052256Unknown不适用

The Heartflow Coronary Disease Progression Evaluation Study

Erasmus Medical Center1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2018年10月5日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nicolas van Mieghem

Director of Interventional Cardiology

Erasmus Medical Center

研究点 (1)

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