Elective Percutaneous Coronary Intervention With or Without Supplemental OXYgen (EPOXY-IMR)
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|ClinicalTrials.gov Identifier: NCT03369184|
Recruitment Status : Terminated (Slow recruitment)
First Posted : December 11, 2017
Last Update Posted : October 5, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease||Drug: Oxygen gas Other: Ambient air||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||65 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Masking Description:||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.|
|Official Title:||Elective Percutaneous Coronary Intervention With or Without Supplemental OXYgen and Evaluation of Effects on Coronary Microcirculation Using the Index of Microcirculatory Resistance|
|Actual Study Start Date :||January 1, 2018|
|Actual Primary Completion Date :||May 1, 2019|
|Actual Study Completion Date :||August 1, 2020|
Experimental: Supplemental oxygen
Inhalation of oxygen 6 L/min through an open face mask
Drug: Oxygen gas
The intervention is administered as previously described. The duration of intervention is 10 minutes.
Sham Comparator: Ambient air
Breathing ambient air through an open face mask
Other: Ambient air
Administered similarly to treatment arm, via an open face mask and during 10 minutes
- Index of Microcirculatory Resistance (IMR) [ Time Frame: Change from baseline to 1 hour ]Measure of microvascular resistance. Intracoronary pressure- and flow-based measurements derived from thermodilution recordings.
- Coronary Flow Reserve (CFR) [ Time Frame: Change from baseline to 1 hour ]Flow-related index based om thermodilution measurements
- High sensitive troponin [ Time Frame: Measured at baseline, after 4, 12 and 24 hours. ]Cardiac biomarker and a measure of periprocedural myocardial damage
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03369184
|Stockholm South General Hospital|
|Stockholm, Sweden, 11883|