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Acute Coronary SyndromePhase 3DETO2X-AMINCT01787110

An Efficacy and Outcome Study of Supplemental Oxygen Treatment in Patients With Suspected Myocardial Infarction

A Phase 3 study testing Oxygen in people with Acute Coronary Syndrome and Non-ST Elevation (NSTEMI) Myocardial Infarction, run by Karolinska Institutet at 34 sites in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 30 years and older
What is being tested?
Oxygen
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6,629 participants
Where
34 sitesSweden
Study dates
Apr 2013to 30 Dec 2016
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • unwillingness to participate
  • inability to comprehend given information
  • continuous oxygen delivery at home prior to inclusion
  • cardiac arrest prior to inclusion

Trial locations and contacts

34 sites in 1 country.

34 sites in 1 country

Sweden34 sites

  • Enköping Hospital

    Enköping, 74525

  • Gävle Hospital

    Gävle, 80187

  • Gothenburg University Hospital, Sahlgrenska

    Gothenburg, 41345

  • Gothenburg University Hospital, Östra

    Gothenburg, 41345

  • Hallands Hospital Halmstad

    Halmstad, 30185

  • Ryhov Hospital Jönköping

    Jönköping, 55185

  • Kalmar Regional Hospital

    Kalmar, 39185

  • Karlstad Hospital

    Karlstad, 65185

  • Kiruna Hospital

    Kiruna, 98131

  • Köping Hospital

    Köping, 73130

  • Kristianstad Hospital

    Kristianstad, 29185

  • Skaraborgs Hospital Lidköping

    Lidköping

  • Linköping University Hospital

    Linköping, 58191

  • Skåne University Hospital Lund

    Lund, 20502

  • Skåne University Hospital Malmö

    Malmö, 20502

  • Sahlgrenska Universitetssjukhus Mölndal

    Mölndal, 41345

  • Vrinnevi Hospital Norrköping

    Norrköping, 60329

  • Norrtälje Hospital

    Norrtälje, 76129

  • Nyköping Hospital

    Nyköping, 61185

  • Örebro University Hospital

    Örebro, 70185

  • Örnsköldsvik Hospital

    Örnsköldsvik, 89189

  • Östersund Hospital

    Östersund, 83183

  • Skaraborgs Hospital Skövde

    Skövde, 54185

  • St: Göran Hospital

    Stockholm, 11281

  • Södersjukhuset

    Stockholm, 11883

  • Karolinska University Hospital Huddinge

    Stockholm, 14186

  • Karolinska University Hospital Solna

    Stockholm, 17176

  • Danderyds Sjukhus

    Stockholm, 18288

  • Härnosand Hospital Sundsvall

    Sundsvall, 85186

  • Trelleborg Hospital

    Trelleborg, 23185

  • Norrlands University Hospital

    Umeå, 90185

  • Uppsala University Hospital

    Uppsala, 75185

  • Hallands Hospital Varberg

    Varberg, 43281

  • Växjö Hospital

    Vaxjo, 35188

Other trials in Sweden

About this study

Official title: DETermination of the Role of OXygen in Suspected Acute Myocardial Infarction (DETO2X-AMI) Based on the SWEDEHEART Registry

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.

Read the detailed description

AIM:

The aim of the DETO2X-AMI trial is to evaluate the role of supplemental oxygen delivery in the setting of acute coronary syndrome myocardial infarction including ST-segment elevation myocardial infarction (STEMI), non ST-segment elevation myocardial infarction (NSTEMI) and unstable angina (UA).

DESIGN:

DETO2X-AMI is a multicentre, interventional, controlled, randomized registry based clinical trial (RRCT) recruiting 6600 patients at cardiac care facilities which report into the SWEDEHEART registry throughout the whole of Sweden.

The SWEDEHEART (Swedish Web-system for Enhancement and Development of Evidence-based care in Heart disease Evaluated According to Recommended Therapies) registry is a nationwide used platform allowing a broad population of all-comers access to the broad registry network which includes:

  • RIKS-HIA (nationwide registry where all ischemia cases treated on cardiac intensive care units are registered),
  • SCAAR (Swedish Coronary Angiography and Angioplasty Registry where nationwide all coronary angiography and percutaneous coronary intervention (PCI) procedures are registered))
  • SEPHIA (nationwide registry for all post AMI follow-up in patients below 75 years of age).

All follow-up will be carried out in SWEDEHEART and other national registries such as the national cause of death register (dödsorsaksregister) or the national patient register (slutenvårdsregister). A similar set-up has been successfully used for the TASTE (Thrombus Aspiration in ST-Elevation myocardial infarction in Scandinavia) trial.

MATERIAL and METHODS:

Patients with normal oxygen saturation (≥90% on pulse oximeter) presenting to the ambulance service or the emergency department (ED) with classical symptoms suggestive of acute coronary syndrome (ACS) and significant ECG changes or elevated cardiac biomarkers (ED) are evaluated for inclusion. If eligible, oral informed consent is obtained by EMD or ED personnel prior to inclusion. Randomization is carried out on the cardiac intensive care unit using a web-based tool as part of registration directly into the national SWEDEHEART registry.

Patients are randomized to either supplemental oxygen delivered by oxymask® (6 L/min) for 12 hours (min 6 hours) or no supplemental O₂. All patients receive standard care according to international ACS guidelines including acute coronary intervention.

EFFICACY OUTCOMES:

Primary efficacy outcome

All-cause mortality at one year in all patients with suspected AMI (ITT).

Secondary efficacy outcomes

In the ITT population and AMI cohort:

  • MACE 1: composite of all-cause mortality or rehospitalization with heart failure*
  • MACE 2: composite of all-cause mortality or rehospitalization with heart failure or readmission with myocardial infarction
  • rehospitalization with heart failure
  • rehospitalization with AMI
  • rehospitalization with shock (Kilip ≥3)*
  • cardiovascular death *
  • health economy

In the STEMI cohort: MACE as a composite of all-cause death, rehospitalization with MI, cardiogenic shock, or stent thrombosis* plus as above.

*These outcomes were specified after the trial had started, but before any treatment comparisons were available.

Primary and secondary outcomes will be assessed at 30 days and one year of follow up. Supplementary per-protocol analysis will be performed.

Subgroup analyses consist of predefined subgroups including gender, age, AMI/Non-AMI, Type-I AMI ( STEMI/NSTEMI), smokers, Hb, oxygen saturation levels, patients with chronic obstructive pulmonary disease, chronic kidney disease and diabetes mellitus.

Two main sub studies will be performed:

DETO2X-Biomarkers, a multicenter sub study to the DETO2X-AMI trial assessing if oxygen treatment enhances oxidative stress, systemic inflammation, and markers of apoptosis and MMPs in ACS patients, thereby potentially increasing myocardial damage and cell death, and potentially the prognosis (see separate trial protocol or clinicaltrials.gov NCT02290080 for details).

DETO2X-OXYPAIN 2, a multicenter sub study to the DETO2X-AMI trial at centers with catheter laboratories evaluating a possible analgesic effect of oxygen in using visual-analog scale (VAS).

Follow-up is carried out according to clinical post AMI routine which includes a standardized registration in the SWEDEHEART registry. Mortality data is obtained from the national cause of death register which is linked to SWEDEHEART.

CONCLUSION:

There is no conclusive evidence from adequately designed and powered trials supporting the routine administration of supplemental oxygen in the setting of suspected AMI. The DETO2X-AMI trial is designed to shed light on this important issue and give guidance to future recommendations.

Being tested
Oxygen
Keywords
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
Medical subject headings
Acute Coronary Syndrome, Non-ST Elevated Myocardial Infarction, Myocardial Infarction, ST Elevation Myocardial Infarction, Angina, Unstable

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OxygenDrug

    see arm description

Study groups in NCT01787110
Study groupRoleWhat they receive
No oxygenNo 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
OxygenActive 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
Receives: Drug: Oxygen

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 1-year all-cause mortality

    1-year all-cause mortality on an intention to treat basis (ITT)

    Measured: 1 year

Secondary outcomes (8)

  1. MACE 1

    All-cause mortality or rehospitalization with heart failure at 1-year

    Measured: 1 year

  2. MACE 2

    All-cause mortality or rehospitalization with heart failure or readmission with myocardial infarction at 1-year

    Measured: 1 year

  3. STEMI-PCI-MACE

    All-cause death or rehospitalization with MI or cardiogenic shock or stent thrombosis at one year

    Measured: 1 year

  4. Rehospitalization with heart failure

    Rehospitalization with heart failure at 1-year

    Measured: 1 year

  5. Rehospitalization with AMI

    Rehospitalization with AMI at 1-year

    Measured: 1 year

  6. Rehospitalization with shock (Killip ≥3)

    Rehospitalization with shock (Killip ≥3) at 1-year

    Measured: 1 year

  7. Cardiovascular death

    Cardiovascular death at 1-year

    Measured: 1 year

  8. 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

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2013 (estimated)
  2. Study startApr 2013
  3. Primary completion30 Dec 2016
  4. Study completion30 Dec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
6,629 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01787110
Sponsor's protocol ID
DETO2X-AMI 2012/287-12
Acronym
DETO2X-AMI
Status last verified
Mar 2017
First submitted
1 Feb 2013
Last updated
11 Dec 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 773507

  • 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.

    PubMed 19699859

  • 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.

    PubMed 22305833

  • 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.

    PubMed 16007057

  • 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.

    PubMed 20846598

  • 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.

    PubMed 20556775

  • 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.

    PubMed 21346260

  • 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.

    PubMed 21146656

  • 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.

    PubMed 22017777

  • 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.

    PubMed 23554440

  • 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.

    PubMed 22424003

  • 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.

    PubMed 24576515

  • 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.

    PubMed 23991656

  • 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.

    PubMed 26002889

  • 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.

    PubMed 26783282

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Oxygen in people with Acute Coronary Syndrome and Non-ST Elevation (NSTEMI) Myocardial Infarction, run by Karolinska Institutet at 34 sites in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

1-year all-cause mortality (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01787110, which also lists 27 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2017.

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