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: January 25, 2016
Last verified: January 2016
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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.

  • 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


Enrollment: 6650
Study Start Date: April 2013
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01787110

Locations
Sweden
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
Danderyds Sjukhus
Stockholm, Sweden, 18288
Södersjukhuset
Stockholm, Sweden, 11883
Karolinska University Hospital Huddinge
Stockholm, Sweden, 14186
Karolinska University Hospital Solna
Stockholm, Sweden, 17176
St: Göran Hospital
Stockholm, Sweden, 11281
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
Investigators
Study Director: Leif Svensson, MD, PHD Karolinska Institutet
  More Information

Additional Information:
Publications:

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 
Study First Received: February 1, 2013
Last Updated: January 25, 2016
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Karolinska Institutet:
Acute coronary syndrome
Acute myocardial infarction
Non ST-segment Myocardial Infarction
ST-segment Myocardial Infarction
STEMI
NSTEMI
Oxygen
Unstable angina
Randomised trial
CMR
Mortality
RCRT
RRCT

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

ClinicalTrials.gov processed this record on July 28, 2016