An Efficacy and Outcome Study of Supplemental Oxygen Treatment in Patients With Suspected Myocardial Infarction
DETO2X-AMI
DETermination of the Role of OXygen in Suspected Acute Myocardial Infarction (DETO2X-AMI) Based on the SWEDEHEART Registry
1 other identifier
interventional
6,629
1 country
34
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2013
Typical duration for phase_3
34 active sites
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
February 1, 2013
CompletedFirst Posted
Study publicly available on registry
February 8, 2013
CompletedStudy Start
First participant enrolled
April 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2016
CompletedDecember 11, 2017
March 1, 2017
3.8 years
February 1, 2013
December 8, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
1-year all-cause mortality
1-year all-cause mortality on an intention to treat basis (ITT)
1 year
Secondary Outcomes (8)
MACE 1
1 year
MACE 2
1 year
STEMI-PCI-MACE
1 year
Rehospitalization with heart failure
1 year
Rehospitalization with AMI
1 year
- +3 more secondary outcomes
Study Arms (2)
No oxygen
NO INTERVENTIONFor 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
Oxygen
ACTIVE COMPARATORFor 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
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- unwillingness to participate
- inability to comprehend given information
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Karolinska Institutetlead
- Swedish Heart Lung Foundationcollaborator
- Swedish Foundation for Strategic Researchcollaborator
- The Swedish Research Councilcollaborator
Study Sites (34)
Enköping Hospital
Enköping, 74525, Sweden
Gävle Hospital
Gävle, 80187, Sweden
Gothenburg University Hospital, Sahlgrenska
Gothenburg, 41345, Sweden
Gothenburg University Hospital, Östra
Gothenburg, 41345, Sweden
Hallands Hospital Halmstad
Halmstad, 30185, Sweden
Ryhov Hospital Jönköping
Jönköping, 55185, Sweden
Kalmar Regional Hospital
Kalmar, 39185, Sweden
Karlstad Hospital
Karlstad, 65185, Sweden
Kiruna Hospital
Kiruna, 98131, Sweden
Köping Hospital
Köping, 73130, Sweden
Kristianstad Hospital
Kristianstad, 29185, Sweden
Skaraborgs Hospital Lidköping
Lidköping, Sweden
Linköping University Hospital
Linköping, 58191, Sweden
Skåne University Hospital Lund
Lund, 20502, Sweden
Skåne University Hospital Malmö
Malmo, 20502, Sweden
Sahlgrenska Universitetssjukhus Mölndal
Mölndal, 41345, Sweden
Vrinnevi Hospital Norrköping
Norrköping, 60329, Sweden
Norrtälje Hospital
Norrtälje, 76129, Sweden
Nyköping Hospital
Nyköping, 61185, Sweden
Örebro University Hospital
Örebro, 70185, Sweden
Örnsköldsvik Hospital
Örnsköldsvik, 89189, Sweden
Östersund Hospital
Östersund, 83183, Sweden
Skaraborgs Hospital Skövde
Skövde, 54185, Sweden
St: Göran Hospital
Stockholm, 11281, Sweden
Södersjukhuset
Stockholm, 11883, Sweden
Karolinska University Hospital Huddinge
Stockholm, 14186, Sweden
Karolinska University Hospital Solna
Stockholm, 17176, Sweden
Danderyds Sjukhus
Stockholm, 18288, Sweden
Härnosand Hospital Sundsvall
Sundsvall, 85186, Sweden
Trelleborg Hospital
Trelleborg, 23185, Sweden
Norrlands University Hospital
Umeå, 90185, Sweden
Uppsala University Hospital
Uppsala, 75185, Sweden
Hallands Hospital Varberg
Varberg, 43281, Sweden
Växjö Hospital
Vaxjo, 35188, Sweden
Related Publications (27)
Rawles JM, Kenmure AC. Controlled trial of oxygen in uncomplicated myocardial infarction. Br Med J. 1976 May 8;1(6018):1121-3. doi: 10.1136/bmj.1.6018.1121.
PMID: 773507BACKGROUNDFarquhar H, Weatherall M, Wijesinghe M, Perrin K, Ranchord A, Simmonds M, Beasley R. Systematic review of studies of the effect of hyperoxia on coronary blood flow. Am Heart J. 2009 Sep;158(3):371-7. doi: 10.1016/j.ahj.2009.05.037. Epub 2009 Jul 15.
PMID: 19699859BACKGROUNDRanchord AM, Argyle R, Beynon R, Perrin K, Sharma V, Weatherall M, Simmonds M, Heatlie G, Brooks N, Beasley R. High-concentration versus titrated oxygen therapy in ST-elevation myocardial infarction: a pilot randomized controlled trial. Am Heart J. 2012 Feb;163(2):168-75. doi: 10.1016/j.ahj.2011.10.013. Epub 2012 Jan 13.
PMID: 22305833BACKGROUNDUkholkina GB, Kostianov IIu, Kuchkina NV, Grendo EP, Gofman IaB. [Effect of oxygenotherapy used in combination with reperfusion in patients with acute myocardial infarction]. Kardiologiia. 2005;45(5):59. No abstract available. Russian.
PMID: 16007057BACKGROUNDMoradkhan R, Sinoway LI. Revisiting the role of oxygen therapy in cardiac patients. J Am Coll Cardiol. 2010 Sep 21;56(13):1013-6. doi: 10.1016/j.jacc.2010.04.052.
PMID: 20846598BACKGROUNDCabello JB, Burls A, Emparanza JI, Bayliss S, Quinn T. Oxygen therapy for acute myocardial infarction. Cochrane Database Syst Rev. 2010 Jun 16;(6):CD007160. doi: 10.1002/14651858.CD007160.pub2.
PMID: 20556775BACKGROUNDBurls A, Cabello JB, Emparanza JI, Bayliss S, Quinn T. Oxygen therapy for acute myocardial infarction: a systematic review and meta-analysis. Emerg Med J. 2011 Nov;28(11):917-23. doi: 10.1136/emj.2010.103564. Epub 2011 Feb 23.
PMID: 21346260BACKGROUNDFrobert O, Lagerqvist B, Gudnason T, Thuesen L, Svensson R, Olivecrona GK, James SK. Thrombus Aspiration in ST-Elevation myocardial infarction in Scandinavia (TASTE trial). A multicenter, prospective, randomized, controlled clinical registry trial based on the Swedish angiography and angioplasty registry (SCAAR) platform. Study design and rationale. Am Heart J. 2010 Dec;160(6):1042-8. doi: 10.1016/j.ahj.2010.08.040.
PMID: 21146656BACKGROUNDKones R. Oxygen therapy for acute myocardial infarction-then and now. A century of uncertainty. Am J Med. 2011 Nov;124(11):1000-5. doi: 10.1016/j.amjmed.2011.04.034.
PMID: 22017777BACKGROUNDShuvy M, Atar D, Gabriel Steg P, Halvorsen S, Jolly S, Yusuf S, Lotan C. Oxygen therapy in acute coronary syndrome: are the benefits worth the risk? Eur Heart J. 2013 Jun;34(22):1630-5. doi: 10.1093/eurheartj/eht110. Epub 2013 Apr 3.
PMID: 23554440BACKGROUNDStub D, Smith K, Bernard S, Bray JE, Stephenson M, Cameron P, Meredith I, Kaye DM; AVOID Study. A randomized controlled trial of oxygen therapy in acute myocardial infarction Air Verses Oxygen In myocarDial infarction study (AVOID Study). Am Heart J. 2012 Mar;163(3):339-345.e1. doi: 10.1016/j.ahj.2011.11.011.
PMID: 22424003BACKGROUNDHofmann R, James SK, Svensson L, Witt N, Frick M, Lindahl B, Ostlund O, Ekelund U, Erlinge D, Herlitz J, Jernberg T. DETermination of the role of OXygen in suspected Acute Myocardial Infarction trial. Am Heart J. 2014 Mar;167(3):322-8. doi: 10.1016/j.ahj.2013.09.022. Epub 2013 Dec 19.
PMID: 24576515BACKGROUNDFrobert O, Lagerqvist B, Olivecrona GK, Omerovic E, Gudnason T, Maeng M, Aasa M, Angeras O, Calais F, Danielewicz M, Erlinge D, Hellsten L, Jensen U, Johansson AC, Karegren A, Nilsson J, Robertson L, Sandhall L, Sjogren I, Ostlund O, Harnek J, James SK; TASTE Trial. Thrombus aspiration during ST-segment elevation myocardial infarction. N Engl J Med. 2013 Oct 24;369(17):1587-97. doi: 10.1056/NEJMoa1308789. Epub 2013 Aug 31.
PMID: 23991656BACKGROUNDStub D, Smith K, Bernard S, Nehme Z, Stephenson M, Bray JE, Cameron P, Barger B, Ellims AH, Taylor AJ, Meredith IT, Kaye DM; AVOID Investigators. Air Versus Oxygen in ST-Segment-Elevation Myocardial Infarction. Circulation. 2015 Jun 16;131(24):2143-50. doi: 10.1161/CIRCULATIONAHA.114.014494. Epub 2015 May 22.
PMID: 26002889BACKGROUNDBulluck H, Hausenloy DJ. Letter by Bulluck and Hausenloy Regarding Article, "Air Versus Oxygen in ST-Segment-Elevation Myocardial Infarction". Circulation. 2016 Jan 19;133(3):e28. doi: 10.1161/CIRCULATIONAHA.115.017968. No abstract available.
PMID: 26783282BACKGROUNDNehme Z, Stub D, Bernard S, Stephenson M, Bray JE, Cameron P, Meredith IT, Barger B, Ellims AH, Taylor AJ, Kaye DM, Smith K; AVOID Investigators. Effect of supplemental oxygen exposure on myocardial injury in ST-elevation myocardial infarction. Heart. 2016 Mar;102(6):444-51. doi: 10.1136/heartjnl-2015-308636. Epub 2016 Jan 6.
PMID: 26740484BACKGROUNDJames S, Rao SV, Granger CB. Registry-based randomized clinical trials--a new clinical trial paradigm. Nat Rev Cardiol. 2015 May;12(5):312-6. doi: 10.1038/nrcardio.2015.33. Epub 2015 Mar 17.
PMID: 25781411BACKGROUNDNedeljkovic ZS, Jacobs AK. Oxygen for ST-Segment-Elevation Myocardial Infarction: Still Up in the Air. Circulation. 2015 Jun 16;131(24):2101-3. doi: 10.1161/CIRCULATIONAHA.115.017072. Epub 2015 May 22. No abstract available.
PMID: 26002888BACKGROUNDSepehrvand N, Ezekowitz JA. Oxygen Therapy in Patients With Acute Heart Failure: Friend or Foe? JACC Heart Fail. 2016 Oct;4(10):783-790. doi: 10.1016/j.jchf.2016.03.026. Epub 2016 Jun 8.
PMID: 27289409BACKGROUNDStub D, Smith K, Bernard S, Nehme Z, Stephenson M, Bray JE, Cameron P, Barger B, Ellims AH, Taylor AJ, Meredith IT, Kaye DM. Response to Letter Regarding Article, "Air Versus Oxygen in ST-Segment-Elevation Myocardial Infarction". Circulation. 2016 Jan 19;133(3):e29. doi: 10.1161/CIRCULATIONAHA.115.019038. No abstract available.
PMID: 26783283BACKGROUNDHofmann R, Abebe TB, Herlitz J, James SK, Erlinge D, Alfredsson J, Jernberg T, Kellerth T, Ravn-Fischer A, Lindahl B, Langenskiold S; DETO2X-SWEDEHEART Investigators. Avoiding Routine Oxygen Therapy in Patients With Myocardial Infarction Saves Significant Expenditure for the Health Care System-Insights From the Randomized DETO2X-AMI Trial. Front Public Health. 2022 Jan 12;9:711222. doi: 10.3389/fpubh.2021.711222. eCollection 2021.
PMID: 35096723DERIVEDHofmann R, Befekadu Abebe T, Herlitz J, James SK, Erlinge D, Yndigegn T, Alfredsson J, Kellerth T, Ravn-Fischer A, Volz S, Lauermann J, Jernberg T, Lindahl B, Langenskiold S. Routine Oxygen Therapy Does Not Improve Health-Related Quality of Life in Patients With Acute Myocardial Infarction-Insights From the Randomized DETO2X-AMI Trial. Front Cardiovasc Med. 2021 Mar 15;8:638829. doi: 10.3389/fcvm.2021.638829. eCollection 2021.
PMID: 33791349DERIVEDLindahl B, Ljung L, Herlitz J, Alfredsson J, Erlinge D, Kellerth T, Omerovic E, Ravn-Fischer A, Sparv D, Yndigegn T, Svensson P, Ostlund O, Jernberg T, James SK, Hofmann R; DETO2X-SWEDEHEART Investigators. Poor long-term prognosis in patients admitted with strong suspicion of acute myocardial infarction but discharged with another diagnosis. J Intern Med. 2021 Aug;290(2):359-372. doi: 10.1111/joim.13272. Epub 2021 Mar 16.
PMID: 33576075DERIVEDJames SK, Erlinge D, Herlitz J, Alfredsson J, Koul S, Frobert O, Kellerth T, Ravn-Fischer A, Alstrom P, Ostlund O, Jernberg T, Lindahl B, Hofmann R; DETO2X-SWEDEHEART Investigators. Effect of Oxygen Therapy on Cardiovascular Outcomes in Relation to Baseline Oxygen Saturation. JACC Cardiovasc Interv. 2020 Feb 24;13(4):502-513. doi: 10.1016/j.jcin.2019.09.016. Epub 2019 Dec 11.
PMID: 31838113DERIVEDNystrom T, James SK, Lindahl B, Ostlund O, Erlinge D, Herlitz J, Omerovic E, Mellbin L, Alfredsson J, Frobert O, Jernberg T, Hofmann R; DETO2X-SWEDEHEART Investigators. Oxygen Therapy in Myocardial Infarction Patients With or Without Diabetes: A Predefined Subgroup Analysis From the DETO2X-AMI Trial. Diabetes Care. 2019 Nov;42(11):2032-2041. doi: 10.2337/dc19-0590. Epub 2019 Aug 31.
PMID: 31473600DERIVEDJernberg T, Lindahl B, Alfredsson J, Berglund E, Bergstrom O, Engstrom A, Erlinge D, Herlitz J, Jumatate R, Kellerth T, Lauermann J, Lindmark K, Lingman M, Ljung L, Nilsson C, Omerovic E, Pernow J, Ravn-Fischer A, Sparv D, Yndigegn T, Ostlund O, James SK, Hofmann R; DETO2X-SWEDEHEART Investigators. Long-Term Effects of Oxygen Therapy on Death or Hospitalization for Heart Failure in Patients With Suspected Acute Myocardial Infarction. Circulation. 2018 Dec 11;138(24):2754-2762. doi: 10.1161/CIRCULATIONAHA.118.036220.
PMID: 30767504DERIVEDHofmann R, James SK, Jernberg T, Lindahl B, Erlinge D, Witt N, Arefalk G, Frick M, Alfredsson J, Nilsson L, Ravn-Fischer A, Omerovic E, Kellerth T, Sparv D, Ekelund U, Linder R, Ekstrom M, Lauermann J, Haaga U, Pernow J, Ostlund O, Herlitz J, Svensson L; DETO2X-SWEDEHEART Investigators. Oxygen Therapy in Suspected Acute Myocardial Infarction. N Engl J Med. 2017 Sep 28;377(13):1240-1249. doi: 10.1056/NEJMoa1706222. Epub 2017 Aug 28.
PMID: 28844200DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Leif Svensson, MD, PHD
Karolinska Institutet
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Cardiology
Study Record Dates
First Submitted
February 1, 2013
First Posted
February 8, 2013
Study Start
April 1, 2013
Primary Completion
December 30, 2016
Study Completion
December 30, 2016
Last Updated
December 11, 2017
Record last verified: 2017-03
Data Sharing
- IPD Sharing
- Will not share