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临床试验/NCT02350439
NCT02350439已完成3 期

Differential Effect of High (200μg/kg/Min) Adenosine Dose on Fractional Flow Reserve in Patients Presenting Variation of FFR ≥0.05 During the Usual Dose of Adenosine Infusion (140μg/kg/Min).

University of Patras1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2015年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
30
试验地点
1
主要终点
Difference between the maximum and minimum value of Pd / Pa ratio during steady state hyperaemia between the 2 groups.

研究概览

简要总结

Fractional flow reserve (FFR) is an established invasive method for assessing the physiological significance of coronary artery stenosis. However, in recent studies it has been observed and reported some degree of variation in the fraction of the coronary artery to the aortic pressure (Pd / Pa) during the infusion of standard adenosine dose (140mg/kg/min). The observed variation may be attributed to a failure to achieve maximal hyperemia with the normal dose. The administration of adenosine at a higher dose (200μg/kg /min) may influence coronary flow reserve (FFR) eliminating Pd / Pa variation during adenosine infusion.

This is a prospective study which will be conducted in patients after coronary angiography with at least one angiographic lesion ≥50% in coronary vessels.

Patients after written consent will undergo assessment of lesion severity with FFR under a three-minute infusion of adenosine 140mg/kg/min. In patients during steady state hyperaemia (determined by visual assessment) exhibiting variation in Pd / Pa ratio ≥ 0.05 (e.g. difference of max Pd/Pa minus min Pd/Pa) the examination will be repeated after 5 min with three-minute infusion under high dose adenosine (200mg/kg/min). The minimum ratio Pd/Pa per 3 beats will be offline analyzed. The FFR during steady hyperemia state is defined as the average of the minimum ratio Pd / Pa per three beats.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18-80 years
  • Patients with at least 1 ≥50% stenosis in a coronary vessel, subjected to FFR assessment, who exhibit variation in Pd / Pa ratio ≥ 0.05 (e.g. difference of max Pd/Pa minus min Pd/Pa) during steady state hyperaemia (determined by visual assessment).
  • Written informed consent

排除标准

  • Left main disease (angiographically> 50%)
  • Cardiogenic shock / hemodynamic instability
  • Previous CABG
  • Increased risk of bradycardia on investigator clinical judgment
  • Severe chronic obstructive pulmonary disease
  • Coronary vessels with tortuosity or extremely calcified
  • Severe left ventricular hypertrophy or severe valvular disease
  • STEMI or non-STEMI within the past five days
  • Previous myocardial infarction in the distribution of the target vessel for the FFR
  • Acute decompensated heart failure.

研究组 & 干预措施

Adenosine intravenous infusion at 200μg/Kg/min

Experimental

Fractional flow reserve assessment under Adenosine intravenous infusion at 200μg/Kg/min

干预措施: Adenosine infusion at 200μg/Kg/min (Drug)

结局指标

主要结局

Difference between the maximum and minimum value of Pd / Pa ratio during steady state hyperaemia between the 2 groups.

时间窗: 10 minutes

Coefficient of variation of Pd / Pa ratio during steady state hyperemia between the 2 groups

时间窗: 10 minutes

次要结局

  • FFR value as determined by the software, between the 2 groups.(10 minutes)
  • FFR during steady state hyperemia.(10 minutes)

研究者

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

Dimitrios Alexopoulos

Professor

University of Patras

研究点 (1)

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