drugset / Trial / NCT01787110
An Efficacy and Outcome Study of Supplemental Oxygen Treatment in Patients With Suspected Myocardial Infarction
Phase 3
Completed
6629 enrolled
Karolinska Institutet
Swedish Foundation for Strategic Research · collabSwedish Heart Lung Foundation · collabThe Swedish Research Council · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2013-04
- Primary completion
- 2016-12-30
- Completion
- 2016-12-30
Publications
- Background 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.
- Background Farquhar 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.
- Background Ranchord 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.
- Background Ukholkina 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.
- Background Moradkhan 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.
- Background Cabello 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.
- Background Burls 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.
- Background Frobert 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.
- Background Kones 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.
- Background Shuvy 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.
- Background Stub 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.
- Background Hofmann 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.
- Background Frobert 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.
- Background Stub 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.
- Background Bulluck 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.
- Background Nehme 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.
- Background James 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.
- Background Nedeljkovic 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.
- Background Sepehrvand 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.
- Background Stub 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.
- Hofmann 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.
- Hofmann 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.
- Lindahl 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.
- James 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.
- Nystrom 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.
- Jernberg 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.
- Hofmann 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Oxygen | Other / unclassified | 6000 ml | Other |