Elective Percutaneous Coronary Intervention With or Without Supplemental OXYgen

• Status: Terminated
• Trial end date: 2020-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Karolinska Institutet

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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