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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Swedish Heart Lung Foundation
Swedish Foundation for Strategic Research
The Swedish Research Council
Information provided by (Responsible Party):
Leif Svensson, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01787110
First received: February 1, 2013
Last updated: December 8, 2016
Last verified: December 2016

February 1, 2013
December 8, 2016
April 2013
January 2017   (final data collection date for primary outcome measure)
1-year all-cause mortality [ Time Frame: 1 year ] [ Designated as safety issue: No ]
1-year all-cause mortality on an intention to treat basis (ITT)
Same as current
Complete list of historical versions of study NCT01787110 on ClinicalTrials.gov Archive Site
  • MACE 1 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    All-cause mortality or rehospitalization with heart failure at 1-year
  • MACE 2 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    All-cause mortality or rehospitalization with heart failure or readmission with myocardial infarction at 1-year
  • STEMI-PCI-MACE [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    All-cause death or rehospitalization with MI or cardiogenic shock or stent thrombosis at one year
  • Rehospitalization with heart failure [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Rehospitalization with heart failure at 1-year
  • Rehospitalization with AMI [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Rehospitalization with AMI at 1-year
  • Rehospitalization with shock (Killip ≥3) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Rehospitalization with shock (Killip ≥3) at 1-year
  • Cardiovascular death [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Cardiovascular death at 1-year
  • Health economics [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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
  • Myocardial damage [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 3-5 days ] [ Designated as safety issue: No ]
    Myocardial damage assessed by cardiac resonance imaging (CMR), by electrocardiogram, biomarkers and coronary angiography using the index of microvascular resistance (IMR)
  • Mortality and morbidity [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 3-5 days, at 30 days and 1-year ] [ Designated as safety issue: No ]
    Evaluate mortality during hospital stay, at 30 days and 1-year. Perform a predefined metaanalysis including previous randomised studies (Rawles et al, Ukholkina et al, Ranchord et al).
  • Heart failure evaluation [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 3-5 days ] [ Designated as safety issue: No ]
    Assessment of the degree of heart failure by echocardiography, biomarkers and number of patients needing medical (iv-drugs such as furosemide, nitroglycerine or inotropes) and/or mechanical (CPAP) assistance.
  • Health economics [ Time Frame: Health economics will be assessed from first contact with the ambulance service through to the duration of hospital stay, an expected average of 3-5 days ] [ Designated as safety issue: No ]
    Health economics concerning supplemental oxygen treatment from prehospital contact of the emergency service through to hospital discharge
Not Provided
Not Provided
 
An Efficacy and Outcome Study of Supplemental Oxygen Treatment in Patients With Suspected Myocardial Infarction
DETermination of the Role of OXygen in Suspected Acute Myocardial Infarction (DETO2X-AMI) Based on the SWEDEHEART Registry

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.

AIM:

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).

DESIGN:

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.

MATERIAL and METHODS:

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.

EFFICACY OUTCOMES:

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.

CONCLUSION:

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Acute Coronary Syndrome
  • Non-ST Elevation (NSTEMI) Myocardial Infarction
  • Acute ST Segment Elevation Myocardial Infarction
  • Angina, Unstable
Drug: Oxygen
see arm description
  • 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
    Intervention: Drug: Oxygen

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
6650
January 2018
January 2017   (final data collection date for primary outcome measure)

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
Both
30 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01787110
DETO2X-AMI 2012/287-12
No
No
Not Provided
Leif Svensson, Karolinska Institutet
Karolinska Institutet
  • Swedish Heart Lung Foundation
  • Swedish Foundation for Strategic Research
  • The Swedish Research Council
Study Director: Leif Svensson, MD, PHD Karolinska Institutet
Karolinska Institutet
December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP