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临床试验/NCT03369184
NCT03369184终止3 期

Elective Percutaneous Coronary Intervention With or Without Supplemental OXYgen and Evaluation of Effects on Coronary Microcirculation Using the Index of Microcirculatory Resistance

Karolinska Institutet1 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2018年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
终止
入组人数
65
试验地点
1
主要终点
Index of Microcirculatory Resistance (IMR)

研究概览

简要总结

Supplemental oxygen is frequently used in patients admitted to hospital due to ischemic heart disease. In the setting of suspected myocardial infarction, clinical practice guidelines advocate the use of supplementary oxygen even in patients with normal levels of peripheral oxygen saturation. The theoretical basis for this practice is that an increase in blood oxygen content may limit ischemia and final myocardial damage and subsequent infarct size. However, although some experimental laboratory data and small studies in humans have supported the use of supplemental oxygen in patients with coronary artery disease, contradicting evidence suggests possible harmful effects, mainly through mechanisms involving coronary vasoconstriction and reduction of myocardial perfusion (hyperoxemic coronary vasoconstriction).

In the EPOXY-IMR trial, the investigators aim to further explore possible detrimental effects from routine use of supplemental oxygen on the coronary circulation with special focus on the small vessels referred to as the coronary microcirculation.

详细描述

Aim:

The aim of the EPOXY-IMR trial is to evaluate the effect of supplemental oxygen on coronary circulation in the setting of elective coronary angiography and percutaneous coronary intervention (PCI). To achieve this, different functional parameters such as the index of microcirculatory resistance (IMR), fractional flow reserve (FFR) and coronary flow reserve (CFR) will be obtained and serial biomarkers (cardiac troponin) will be analyzed.

Background:

Coronary artery disease (CAD) based on arteriosclerotic narrowing of the coronary blood vessels is the most common cause of death in the western world. To determine the severity of the disease in symptomatic patients and guide optimal therapy, coronary angiography is frequently performed. Simplified, three outcomes can be found:

  1. No or mild evidence of CAD leading to continuous medical therapy.
  2. Severe disease demanding revascularization therapy done by either percutaneous coronary intervention (PCI), where most commonly balloon dilatation followed by placement of a metal stent in the coronary vessel is performed, or coronary artery bypass grafting (CABG).
  3. In patients with moderate disease further functional testing is required to assess the gravity of the narrowing. This can be achieved by placing a pressure sensor equipped guide wire to the diseased artery comparing blood pressure proximal and distal to the stenosis during hyperemia, known as Fractional Flow Reserve (FFR). Although based on pressure recordings, FFR is a highly accurate measure of the flow limitation of a given stenosis. A common cut-off value of 0,8 is used where a lower value mandates therapy as in patients with severe disease.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

盲法说明

The patients are randomized in a double blinded fashion by a designated study nurse (simple envelope randomization) to either supplemental oxygen 6l/min delivered by an open face mask (Oxymask®) or ambient air (sham placement of Oxymask®). Neither the patient, nor the performing physician will be aware of the randomization status. Peripheral oxygen saturation will be disclosed only to the nurse responsible for randomization.

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

  • Adults ≥ 18 years of age, AND
  • Undergoing elective coronary angiography due to suspected stabile coronary artery disease
  • Evidence of moderate (40%-79%) stenosis, requiring further routine assessment with FFR.
  • Informed consent

排除标准

  • Acute coronary syndrome or myocardial infarction within 7 days
  • Hypoxia with oxygen saturation measured on pulse oximeter < 90% with the patient breathing air
  • Left ventricular hypertrophy on echocardiography (septum >13mm)
  • Asthma (not COPD)
  • Advanced AV-block without pacemaker in situ
  • Altered conscious state/inability to provide informed consent

研究组 & 干预措施

Supplemental oxygen

Experimental

Inhalation of oxygen 6 L/min through an open face mask

干预措施: Oxygen gas (Drug)

Ambient air

Sham Comparator

Breathing ambient air through an open face mask

干预措施: Ambient air (Other)

结局指标

主要结局

Index of Microcirculatory Resistance (IMR)

时间窗: Change from baseline to 1 hour

Measure of microvascular resistance. Intracoronary pressure- and flow-based measurements derived from thermodilution recordings.

次要结局

  • High sensitive troponin(Measured at baseline, after 4, 12 and 24 hours.)
  • Coronary Flow Reserve (CFR)(Change from baseline to 1 hour)

研究者

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

Nils Witt

Principal Investigator

Karolinska Institutet

研究点 (1)

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