跳至主要内容
临床试验/NCT03824600
NCT03824600已完成不适用

Physiological Patterns of Coronary Artery Disease

Onze Lieve Vrouw Hospital2 个研究点 分布在 1 个国家目标入组 117 人开始时间: 2017年11月24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
117
试验地点
2
主要终点
Physiological Patterns of Coronary Artery Disease (i.e. focal, diffuse or combined)

研究概览

简要总结

Registry of patients undergoing invasive fractional flow reserve measurement using a motorized device.

详细描述

A prospective registry of patients undergoing clinically indicated coronary angiography with fractional flow reserve evaluation for vessels with intermediate coronary lesions defined as visual diameter stenosis between 30% and 70%. A motorized fractional flow reservepullback evaluation will be performed at the discretion of the operators. The objective of the present study is to describe the physiological patterns of coronary artery disease using motorized coronary pressure pullbacks during continuous hyperemia in patients with stable coronary artery disease.

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

  • Stable coronary artery disease

排除标准

  • acute coronary syndromes
  • previous coronary artery bypass grafting
  • significant valvular disease
  • severe obstructive pulmonary disease or asthma bronchial
  • severe tortuosity or severe calcification

结局指标

主要结局

Physiological Patterns of Coronary Artery Disease (i.e. focal, diffuse or combined)

时间窗: Immediate post-procedure. No follow-up is schedule for this trial.

Describe the physiological patterns of coronary artery disease using motorized coronary pressure pullbacks during continuous hyperemia in patients with stable coronary artery disease. A pullback device adapted to grip the coronary pressure wire with a speed of 1 mm/sec during continued pressure recording will be used. A fractional flow reserve value every 100 microns will be extracted from the pressure tracing and plotted against the length to generate a pullback curve. Fractional flow reserve will be defined as the ratio of the moving average of the proximal and distal coronary pressures. The patterns of physiological disease will be classified as focal or diffuse according to the visual inspection of the fractional flow reserve pullback curve. The patterns of coronary artery disease will be reported as a focal, diffuse or combined pattern (i.e. focal and diffuse).

次要结局

未报告次要终点

研究者

发起方
Onze Lieve Vrouw Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jeroen Sonck

Co-Director Catheterization Laboratory

Onze Lieve Vrouw Hospital

研究点 (2)

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