跳至主要内容
临床试验/NCT06008041
NCT06008041进行中(未招募)不适用

Multimodal Epicardial and Endocardial COronary PHYsiological Evaluation in Pathological Situations

University Hospital, Brest1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2023年7月13日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
400
试验地点
1
主要终点
Index of Microcirculatory Resistance (IMR)

研究概览

简要总结

When performing coronary angiography in a stable situation, the identification of an intermediate coronary lesion (between 50 and 70%) is common, and requires additional functional evaluation. The gold standard for this evaluation is Fractional Flow Reserve (FFR). FFR is a flow ratio transformed into a pressure ratio by simplification, neglecting some parameters, especially microcirculatory resistance.

The aim of this study is to investigate hemodynamic and structural assessment induced in specific conditions, and their repercussion on functional assessment by FFR to implement the diagnostic approach and personalize it for each patient.

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 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Intermediate coronary lesion (between 50 and 70%)

排除标准

  • Hemodynamic instability
  • Adenosine hypersensitivity
  • Severe chronic obstructive pulmonary disease
  • Wolff parkinson white
  • High degree atriovenricular block
  • Left-right shunt
  • Carotid artery stenosis with hemodynamic insufficiency
  • Pregnancy

结局指标

主要结局

Index of Microcirculatory Resistance (IMR)

时间窗: During coronary angiography

IMR = Pd x Tmn at maximal hyperhemia Normal range \< 25

次要结局

  • Quantitative Flow Ratio (QFR)(During coronary angiography)
  • Death(12 months)
  • Fractional Flow Reserve (FFR)(During coronary angiography)
  • Resting Full cycle Ratio (RFR)(During coronary angiography)
  • Coronary Flow Reserve (CFR)(During coronary angiography)
  • Angio-IMR(During coronary angiography)
  • Angina pectoris (CCS)(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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