drugset / Trial / NCT03369184

Elective Percutaneous Coronary Intervention With or Without Supplemental OXYgen

NCT03369184

Phase 3 Terminated 65 enrolled Karolinska Institutet
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2018-01-01
Primary completion
2019-05-01
Completion
2020-08-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Oxygen gas Unknown Inhaled