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Trial record 2 of 3 for:    Determination of the Role of Oxygen in Suspected Acute Myocardial Infarction
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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
Sponsor:
Collaborators:
Swedish Heart Lung Foundation
Swedish Foundation for Strategic Research
The Swedish Research Council
Information provided by (Responsible Party):
Leif Svensson, Karolinska Institutet

Study Description
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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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Study Design
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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
Actual Primary Completion Date : December 30, 2016
Actual Study Completion Date : December 30, 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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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
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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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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


Locations
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Sponsors and Collaborators
Karolinska Institutet
Swedish Heart Lung Foundation
Swedish Foundation for Strategic Research
The Swedish Research Council
Investigators
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Study Director: Leif Svensson, MD, PHD Karolinska Institutet
More Information
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Additional Information:

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Leif Svensson, Professor of Cardiology, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01787110    
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
Oxygen
STEMI
NSTEMI
 Unstable angina
Randomised trial
CMR
Mortality
RCRT
RRCT
Additional relevant MeSH terms:
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Myocardial Infarction
Acute Coronary Syndrome
ST Elevation Myocardial Infarction
Infarction
Myocardial Ischemia
Angina, Unstable
Pathologic Processes
Ischemia
 Necrosis
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Angina Pectoris
Chest Pain
Pain
Neurologic Manifestations