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临床试验/NCT04598308
NCT04598308Unknown不适用

EUROpean Coronary microCirculatory Resistance and Absolute Flow Trial: An European Registry

Catharina Ziekenhuis Eindhoven1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2020年10月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
200
试验地点
1
主要终点
clinical treatment assessment

研究概览

简要总结

Rationale: coronary microvascular disease is a relatively 'new' entity within the field of cardiology. The investigators are able to investigate the microcirculation by measurements performed in the catheterization laboratory. But even though measurements are performed on a daily basis, a lot of questions regarding microvascular disease remain. The rationale of this registry is to get an overview of patients and measurement values in daily routine practice.

Objective and main endpoint: No previous registries have been set-up where coronary blood flow and resistance was systematically stored. Therefore the analyses will be mainly descriptive. The objective is to acquire a better insight in the indications and use of this technique in everyday practice , its consequences for clinical decision making, and to enable interventionalists to exchange mutual knowledge about this specific methodology and about the coronary microcirculation in general.

Study design: prospective registry

Study population: All patients who underwent coronary angiography with or without coronary intervention for any reason and if an indication for the foreseen intracoronary physiologic measurements is present according to the discretion of the operator.

Intervention (if applicable): none, only usage of measurement data. The only 'intervention' for all patients is a questionnaire.

详细描述

This registry only collects all measurement data from normal/routine physiologic assessment in the cathlab. These measurements are performed on a daily basis. The following paragraph will explain these routine measurements briefly.

Short description of the procedure Coronary angiography, PCI (if indicated), and physiologic measurements are performed completely according to normal routine. Physiologic measurements may include FFR, NHPR, IMR, CFR, absolute flow (Q) and microcirculatory resistance (Rmicro or MRR) measurement.

Intention to measure Q and Rmicro are mandatory to be included in this registry.

If there is failure to measure Q and/or Rmicro , it should be carefully noted including the reason for failure.

Coronary physiologic measurements may be performed either prior or after PCI, if applicable. If they are performed before PCI, it is recommended (according to Good Clinical Practice) but not absolutely mandatory to repeat these measurements also after PCI.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

clinical treatment assessment

时间窗: 1 year

change in clinical decision making after invasive assessment of the microcirculation

次要结局

  • IMR and resistance measurement(2 years)

研究者

发起方
Catharina Ziekenhuis Eindhoven
申办方类型
Other
责任方
Principal Investigator
主要研究者

Danielle Keulards

Principal investigator

Catharina Ziekenhuis Eindhoven

研究点 (1)

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