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Elective Percutaneous Coronary Intervention With or Without Supplemental OXYgen (EPOXY-IMR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03369184
Recruitment Status : Terminated (Slow recruitment)
First Posted : December 11, 2017
Last Update Posted : October 5, 2020
Sponsor:
Information provided by (Responsible Party):
Nils Witt, Karolinska Institutet

Brief 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.


Condition or disease Intervention/treatment Phase
Coronary Artery Disease Drug: Oxygen gas Other: Ambient air Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
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.
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Coronary Flow Reserve (CFR) [ Time Frame: Change from baseline to 1 hour ]
    Flow-related index based om thermodilution measurements

  2. High sensitive troponin [ Time Frame: Measured at baseline, after 4, 12 and 24 hours. ]
    Cardiac biomarker and a measure of periprocedural myocardial damage



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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Sweden
Stockholm South General Hospital
Stockholm, Sweden, 11883
Sponsors and Collaborators
Karolinska Institutet
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Nils Witt, Principal Investigator, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT03369184    
Other Study ID Numbers: 2017-10.1
First Posted: December 11, 2017    Key Record Dates
Last Update Posted: October 5, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Nils Witt, Karolinska Institutet:
Coronary flow
Coronary vascular resistance
Supplemental oxygen
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases