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An Efficacy and Outcome Study of Supplemental Oxygen Treatment in Patients With Suspected Myocardial Infarction (DETO2X-AMI)

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ClinicalTrials.gov Identifier: NCT01787110
Recruitment Status : Completed
First Posted : February 8, 2013
Last Update Posted : December 11, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:

The use of supplemental oxygen in the setting of suspected acute myocardial infarction (AMI) is manifested in international treatment guidelines and established in prehospital and hospital clinical routine throughout the world.

However, to date there is no conclusive evidence from adequately designed and powered trials supporting this practice. Existing data is conflicting and failing to clarify the role of supplemental oxygen in AMI.

The DETO2X-AMI trial is designed to shed light on this important issue.

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Non-ST Elevation (NSTEMI) Myocardial Infarction Acute ST Segment Elevation Myocardial Infarction Angina, Unstable Drug: Oxygen Phase 3

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Detailed Description:


The aim of the DETO2X-AMI trial is to evaluate the role of supplemental oxygen delivery in the setting of acute coronary syndrome myocardial infarction including ST-segment elevation myocardial infarction (STEMI), non ST-segment elevation myocardial infarction (NSTEMI) and unstable angina (UA).


DETO2X-AMI is a multicentre, interventional, controlled, randomized registry based clinical trial (RRCT) recruiting 6600 patients at cardiac care facilities which report into the SWEDEHEART registry throughout the whole of Sweden.

The SWEDEHEART (Swedish Web-system for Enhancement and Development of Evidence-based care in Heart disease Evaluated According to Recommended Therapies) registry is a nationwide used platform allowing a broad population of all-comers access to the broad registry network which includes:

  • RIKS-HIA (nationwide registry where all ischemia cases treated on cardiac intensive care units are registered),
  • SCAAR (Swedish Coronary Angiography and Angioplasty Registry where nationwide all coronary angiography and percutaneous coronary intervention (PCI) procedures are registered))
  • SEPHIA (nationwide registry for all post AMI follow-up in patients below 75 years of age).

All follow-up will be carried out in SWEDEHEART and other national registries such as the national cause of death register (dödsorsaksregister) or the national patient register (slutenvårdsregister). A similar set-up has been successfully used for the TASTE (Thrombus Aspiration in ST-Elevation myocardial infarction in Scandinavia) trial.


Patients with normal oxygen saturation (≥90% on pulse oximeter) presenting to the ambulance service or the emergency department (ED) with classical symptoms suggestive of acute coronary syndrome (ACS) and significant ECG changes or elevated cardiac biomarkers (ED) are evaluated for inclusion. If eligible, oral informed consent is obtained by EMD or ED personnel prior to inclusion. Randomization is carried out on the cardiac intensive care unit using a web-based tool as part of registration directly into the national SWEDEHEART registry.

Patients are randomized to either supplemental oxygen delivered by oxymask® (6 L/min) for 12 hours (min 6 hours) or no supplemental O₂. All patients receive standard care according to international ACS guidelines including acute coronary intervention.


Primary efficacy outcome

All-cause mortality at one year in all patients with suspected AMI (ITT).

Secondary efficacy outcomes

In the ITT population and AMI cohort:

  • MACE 1: composite of all-cause mortality or rehospitalization with heart failure*
  • MACE 2: composite of all-cause mortality or rehospitalization with heart failure or readmission with myocardial infarction
  • rehospitalization with heart failure
  • rehospitalization with AMI
  • rehospitalization with shock (Kilip ≥3)*
  • cardiovascular death *
  • health economy

In the STEMI cohort: MACE as a composite of all-cause death, rehospitalization with MI, cardiogenic shock, or stent thrombosis* plus as above.

*These outcomes were specified after the trial had started, but before any treatment comparisons were available.

Primary and secondary outcomes will be assessed at 30 days and one year of follow up. Supplementary per-protocol analysis will be performed.

Subgroup analyses consist of predefined subgroups including gender, age, AMI/Non-AMI, Type-I AMI ( STEMI/NSTEMI), smokers, Hb, oxygen saturation levels, patients with chronic obstructive pulmonary disease, chronic kidney disease and diabetes mellitus.

Two main sub studies will be performed:

DETO2X-Biomarkers, a multicenter sub study to the DETO2X-AMI trial assessing if oxygen treatment enhances oxidative stress, systemic inflammation, and markers of apoptosis and MMPs in ACS patients, thereby potentially increasing myocardial damage and cell death, and potentially the prognosis (see separate trial protocol or clinicaltrials.gov NCT02290080 for details).

DETO2X-OXYPAIN 2, a multicenter sub study to the DETO2X-AMI trial at centers with catheter laboratories evaluating a possible analgesic effect of oxygen in using visual-analog scale (VAS).

Follow-up is carried out according to clinical post AMI routine which includes a standardized registration in the SWEDEHEART registry. Mortality data is obtained from the national cause of death register which is linked to SWEDEHEART.


There is no conclusive evidence from adequately designed and powered trials supporting the routine administration of supplemental oxygen in the setting of suspected AMI. The DETO2X-AMI trial is designed to shed light on this important issue and give guidance to future recommendations.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6629 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: DETermination of the Role of OXygen in Suspected Acute Myocardial Infarction (DETO2X-AMI) Based on the SWEDEHEART Registry
Actual Study Start Date : April 2013
Primary Completion Date : December 30, 2016
Study Completion Date : December 30, 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
No Intervention: No oxygen

For patients randomised to withholding oxygen treatment

  • no oxygen is administered at any time as long as the oxygen saturation is ≥90% on pulse oximeter (repetitive checks are performed)
  • all patients receive standard acute coronary syndrome treatment including reperfusion strategies
  • observation duration 12 hours
Active Comparator: Oxygen

For patients randomised to oxygen therapy:

  • 6 L/min of oxygen delivered by oxymask® started immediately after inclusion of the ambulance service or in the emergency department given continuously for 6-12 hours (at least 6 hours)
  • all patients receive standard acute coronary syndrome treatment including reperfusion strategies
Drug: Oxygen
see arm description

Outcome Measures

Primary Outcome Measures :
  1. 1-year all-cause mortality [ Time Frame: 1 year ]
    1-year all-cause mortality on an intention to treat basis (ITT)

Secondary Outcome Measures :
  1. MACE 1 [ Time Frame: 1 year ]
    All-cause mortality or rehospitalization with heart failure at 1-year

  2. MACE 2 [ Time Frame: 1 year ]
    All-cause mortality or rehospitalization with heart failure or readmission with myocardial infarction at 1-year

  3. STEMI-PCI-MACE [ Time Frame: 1 year ]
    All-cause death or rehospitalization with MI or cardiogenic shock or stent thrombosis at one year

  4. Rehospitalization with heart failure [ Time Frame: 1 year ]
    Rehospitalization with heart failure at 1-year

  5. Rehospitalization with AMI [ Time Frame: 1 year ]
    Rehospitalization with AMI at 1-year

  6. Rehospitalization with shock (Killip ≥3) [ Time Frame: 1 year ]
    Rehospitalization with shock (Killip ≥3) at 1-year

  7. Cardiovascular death [ Time Frame: 1 year ]
    Cardiovascular death at 1-year

  8. Health economics [ Time Frame: 1 year ]
    Health economics concerning supplemental oxygen treatment from prehospital contact of the emergency service, hospital stay until follow-up 1 year in patients with AMI below 75 years of age

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • symptoms (chest pain, dyspnea) indicating acute myocardial ischemia within the last 6 hours
  • ECG changes (ST-segment elevation ≥ 2 mm V1-V4, or ≥ 1 mm in other leads, ST-segment depression >1 mm in any lead, negative T-wave in leads V2-V6, pathological Q-wave in at least 2 adjacent leads), left bundle branch block

and/or elevated levels of cardiac troponin levels in the ED

indicating acute myocardial ischemia

  • oxygen saturation ≥90% (pulse oximeter)
  • age ≥30

Exclusion Criteria:

  • unwillingness to participate
  • inability to comprehend given information
  • continuous oxygen delivery at home prior to inclusion
  • cardiac arrest prior to inclusion
Contacts and Locations

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): NCT01787110

Enköping Hospital
Enköping, Sweden, 74525
Gothenburg University Hospital, Sahlgrenska
Gothenburg, Sweden, 41345
Gothenburg University Hospital, Östra
Gothenburg, Sweden, 41345
Gävle Hospital
Gävle, Sweden, 80187
Hallands Hospital Halmstad
Halmstad, Sweden, 30185
Ryhov Hospital Jönköping
Jönköping, Sweden, 55185
Kalmar Regional Hospital
Kalmar, Sweden, 39185
Karlstad Hospital
Karlstad, Sweden, 65185
Kiruna Hospital
Kiruna, Sweden, 98131
Kristianstad Hospital
Kristianstad, Sweden, 29185
Köping Hospital
Köping, Sweden, 73130
Skaraborgs Hospital Lidköping
Lidköping, Sweden
Linköping University Hospital
Linköping, Sweden, 58191
Skåne University Hospital Lund
Lund, Sweden, 20502
Skåne University Hospital Malmö
Malmö, Sweden, 20502
Sahlgrenska Universitetssjukhus Mölndal
Mölndal, Sweden, 41345
Vrinnevi Hospital Norrköping
Norrköping, Sweden, 60329
Norrtälje Hospital
Norrtälje, Sweden, 76129
Nyköping Hospital
Nyköping, Sweden, 61185
Skaraborgs Hospital Skövde
Skövde, Sweden, 54185
St: Göran Hospital
Stockholm, Sweden, 11281
Stockholm, Sweden, 11883
Karolinska University Hospital Huddinge
Stockholm, Sweden, 14186
Karolinska University Hospital Solna
Stockholm, Sweden, 17176
Danderyds Sjukhus
Stockholm, Sweden, 18288
Härnosand Hospital Sundsvall
Sundsvall, Sweden, 85186
Trelleborg Hospital
Trelleborg, Sweden, 23185
Norrlands University Hospital
Umeå, Sweden, 90185
Uppsala University Hospital
Uppsala, Sweden, 75185
Hallands Hospital Varberg
Varberg, Sweden, 43281
Växjö Hospital
Växjö, Sweden, 35188
Örebro University Hospital
Örebro, Sweden, 70185
Örnsköldsvik Hospital
Örnsköldsvik, Sweden, 89189
Östersund Hospital
Östersund, Sweden, 83183
Sponsors and Collaborators
Karolinska Institutet
Swedish Heart Lung Foundation
Swedish Foundation for Strategic Research
The Swedish Research Council
Study Director: Leif Svensson, MD, PHD Karolinska Institutet
More Information

Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Leif Svensson, Professor of Cardiology, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01787110     History of Changes
Other Study ID Numbers: DETO2X-AMI 2012/287-12
First Posted: February 8, 2013    Key Record Dates
Last Update Posted: December 11, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Leif Svensson, Karolinska Institutet:
Acute coronary syndrome
Acute myocardial infarction
Non ST-segment Myocardial Infarction
ST-segment Myocardial Infarction
Unstable angina
Randomised trial

Additional relevant MeSH terms:
Myocardial Infarction
Acute Coronary Syndrome
ST Elevation Myocardial Infarction
Angina, Unstable
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Angina Pectoris
Chest Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms