Acute Coronary Syndrome Clinical Trial
— DETO2X-AMIOfficial title:
DETermination of the Role of OXygen in Suspected Acute Myocardial Infarction (DETO2X-AMI) Based on the SWEDEHEART Registry
Verified date | March 2017 |
Source | Karolinska Institutet |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 6629 |
Est. completion date | December 30, 2016 |
Est. primary completion date | December 30, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 30 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Sweden | Enköping Hospital | Enköping | |
Sweden | Gävle Hospital | Gävle | |
Sweden | Gothenburg University Hospital, Östra | Gothenburg | |
Sweden | Gothenburg University Hospital, Sahlgrenska | Gothenburg | |
Sweden | Hallands Hospital Halmstad | Halmstad | |
Sweden | Ryhov Hospital Jönköping | Jönköping | |
Sweden | Kalmar Regional Hospital | Kalmar | |
Sweden | Karlstad Hospital | Karlstad | |
Sweden | Kiruna Hospital | Kiruna | |
Sweden | Köping Hospital | Köping | |
Sweden | Kristianstad Hospital | Kristianstad | |
Sweden | Skaraborgs Hospital Lidköping | Lidköping | |
Sweden | Linköping University Hospital | Linköping | |
Sweden | Skåne University Hospital Lund | Lund | |
Sweden | Skåne University Hospital Malmö | Malmö | |
Sweden | Sahlgrenska Universitetssjukhus Mölndal | Mölndal | |
Sweden | Vrinnevi Hospital Norrköping | Norrköping | |
Sweden | Norrtälje Hospital | Norrtälje | |
Sweden | Nyköping Hospital | Nyköping | |
Sweden | Örebro University Hospital | Örebro | |
Sweden | Örnsköldsvik Hospital | Örnsköldsvik | |
Sweden | Östersund Hospital | Östersund | |
Sweden | Skaraborgs Hospital Skövde | Skövde | |
Sweden | Danderyds Sjukhus | Stockholm | |
Sweden | Karolinska University Hospital Huddinge | Stockholm | |
Sweden | Karolinska University Hospital Solna | Stockholm | |
Sweden | Södersjukhuset | Stockholm | |
Sweden | St: Göran Hospital | Stockholm | |
Sweden | Härnosand Hospital Sundsvall | Sundsvall | |
Sweden | Trelleborg Hospital | Trelleborg | |
Sweden | Norrlands University Hospital | Umeå | |
Sweden | Uppsala University Hospital | Uppsala | |
Sweden | Hallands Hospital Varberg | Varberg | |
Sweden | Växjö Hospital | Växjö |
Lead Sponsor | Collaborator |
---|---|
Karolinska Institutet | Swedish Foundation for Strategic Research, Swedish Heart Lung Foundation, The Swedish Research Council |
Sweden,
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. — View Citation
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. Review. — View Citation
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. Review. Update in: Cochrane Database Syst Rev. 2013;8:CD007160. — View Citation
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. Review. — View Citation
Fröbert 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. — View Citation
Fröbert O, Lagerqvist B, Olivecrona GK, Omerovic E, Gudnason T, Maeng M, Aasa M, Angerås O, Calais F, Danielewicz M, Erlinge D, Hellsten L, Jensen U, Johansson AC, Kåregren A, Nilsson J, Robertson L, Sandhall L, Sjögren 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. Erratum in: N Engl J Med. 2014 Aug 21;371(8):786. — View Citation
Hofmann R, James SK, Svensson L, Witt N, Frick M, Lindahl B, Östlund 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. — View Citation
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. Review. — View Citation
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. Review. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Rawles JM, Kenmure AC. Controlled trial of oxygen in uncomplicated myocardial infarction. Br Med J. 1976 May 8;1(6018):1121-3. — View Citation
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. Review. — View Citation
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. Review. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. Russian. — View Citation
* Note: There are 20 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 1-year all-cause mortality | 1-year all-cause mortality on an intention to treat basis (ITT) | 1 year | |
Secondary | MACE 1 | All-cause mortality or rehospitalization with heart failure at 1-year | 1 year | |
Secondary | MACE 2 | All-cause mortality or rehospitalization with heart failure or readmission with myocardial infarction at 1-year | 1 year | |
Secondary | STEMI-PCI-MACE | All-cause death or rehospitalization with MI or cardiogenic shock or stent thrombosis at one year | 1 year | |
Secondary | Rehospitalization with heart failure | Rehospitalization with heart failure at 1-year | 1 year | |
Secondary | Rehospitalization with AMI | Rehospitalization with AMI at 1-year | 1 year | |
Secondary | Rehospitalization with shock (Killip =3) | Rehospitalization with shock (Killip =3) at 1-year | 1 year | |
Secondary | Cardiovascular death | Cardiovascular death at 1-year | 1 year | |
Secondary | Health economics | 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 | 1 year |
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