NCT03369184

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at below P25 for phase_3 coronary-artery-disease

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 28, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 11, 2017

Completed
21 days until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

October 5, 2020

Status Verified

September 1, 2020

Enrollment Period

1.3 years

First QC Date

November 28, 2017

Last Update Submit

September 30, 2020

Conditions

Coronary Artery Disease

Keywords

Coronary flowCoronary vascular resistanceSupplemental oxygen

Outcome Measures

Primary Outcomes (1)

  • Index of Microcirculatory Resistance (IMR)

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

    Change from baseline to 1 hour

Secondary Outcomes (2)

  • Coronary Flow Reserve (CFR)

    Change from baseline to 1 hour

  • High sensitive troponin

    Measured at baseline, after 4, 12 and 24 hours.

Study Arms (2)

Supplemental oxygen

EXPERIMENTAL

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

Drug: Oxygen gas

Ambient air

SHAM COMPARATOR

Breathing ambient air through an open face mask

Other: Ambient air

Interventions

Oxygen gasDRUG

The intervention is administered as previously described. The duration of intervention is 10 minutes.

Supplemental oxygen
Ambient airOTHER

Administered similarly to treatment arm, via an open face mask and during 10 minutes

Ambient air

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stockholm South General Hospital

Stockholm, 11883, Sweden

Location

Related Publications (1)

  • Santos-Pardo I, Alstrom P, Witt N. Index of Microcirculatory Resistance Measured during Intracoronary Adenosine-Induced Hyperemia. J Interv Cardiol. 2020 May 12;2020:4829647. doi: 10.1155/2020/4829647. eCollection 2020.

    PMID: 32508541DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

nitroxParticulate Matter

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Complex Mixtures

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 28, 2017

First Posted

December 11, 2017

Study Start

January 1, 2018

Primary Completion

May 1, 2019

Study Completion

August 1, 2020

Last Updated

October 5, 2020

Record last verified: 2020-09

Locations

SE(1)