An Efficacy and Outcome Study of Supplemental Oxygen Treatment in Patients With Suspected Myocardial Infarction (DETO2X-AMI)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Karolinska Institutet
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: March 27, 2014
Last verified: March 2014
  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


Estimated Enrollment: 6600
Study Start Date: April 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (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

  Hide Detailed Description

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).

All follow-up will be carried out in SWEDEHEART and other national registries such as the national death origin registry (dödsorsaksregister) or the in-patient care registry (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.

Primary endpoint is 1-year all-cause mortality. Secondary endpoints will furthermore evaluate mortality, complications during hospital stay, heart failure (echocardiography, registry), myocardial damage using cardiac resonance imaging (CMR), electrocardiogram, modern biomarkers and coronary angiography and health economics.

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 death origin registry 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.

  Eligibility

Ages Eligible for Study:   30 Years and older
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

Contacts
Contact: Leif Svensson, MD, PHD +4686161918 leif.svensson@sodersjukhuset.se
Contact: Robin Hofmann, MD +4686162913 robin.hofmann@sodersjukhuset.se

Locations
Sweden
Enköping Hospital Recruiting
Enköping, Sweden, 74525
Contact: Lena Forsman, MD       lena.forsman@lul.se   
Principal Investigator: Lena Forsman, MD         
Gothenburg university Hospital, Östra Hospital Not yet recruiting
Gothenburg, Sweden, 41345
Contact: Björn Hornestam, MD       bjorn.hornestam@vgregion.se   
Principal Investigator: Björn Hornestam, MD         
Gothenburg University Hospital Recruiting
Gothenburg, Sweden, 41345
Contact: Johan Herlitz, MD, PHD       johan.herlitz@gu.se   
Principal Investigator: Johan Herlitz, MD, PHD         
Gävle Hospital Recruiting
Gävle, Sweden, 80187
Contact: Robert Kastberg, MD       robert.kastberg@lg.se   
Principal Investigator: Lars Svennberg, MD         
Hallands Hospital Halmstad Not yet recruiting
Halmstad, Sweden, 30185
Contact: Markus Lingman, MD, PHD       markus.lingman@regionhalland.se   
Principal Investigator: Markus Lingman, MD,PHD         
Ryhov Hospital Jönköping Recruiting
Jönköping, Sweden, 55185
Contact: Jan-Erik Karlsson, MD, PHD       Jan-Erik.Karlsson@lj.se   
Principal Investigator: Jan-Erik Karlsson, MD, PHD         
Kalmar Regional Hospital Recruiting
Kalmar, Sweden, 39185
Contact: Jörg Carlsson, MD, PHD       jorg.carlsson@ltkalmar.se   
Principal Investigator: Jörg Carlsson, MD, PHD         
Karlstad Hospital Recruiting
Karlstad, Sweden, 65185
Contact: Urban Haaga, MD       Urban.Haaga@liv.se   
Principal Investigator: Urban Haaga, RN         
Kiruna Hospital Recruiting
Kiruna, Sweden, 98131
Contact: Fredrik Kjellberg, MD       Fredrik.Kjellberg@nll.se   
Principal Investigator: Fredrik Kjellberg, MD         
Kristianstad Hospital Not yet recruiting
Kristianstad, Sweden, 29185
Contact: Thomas Pettersson, MD       thomas.pettersson@skane.se   
Principal Investigator: Thomas Pettersson, MD         
Skaraborgs Hospital Lidköping Not yet recruiting
Lidköping, Sweden
Contact: Magnus Peterson, MD       magnus.peterson@vgregion.se   
Principal Investigator: Magnus Peterson, MD         
Linköping University Hospital Recruiting
Linköping, Sweden, 58191
Contact: Joakim Alfredsson, MD, PHD       joakim.alfredsson@liu.se   
Contact: Lennart Nilsson, MD, PHD       lennart.nilsson@liu.se   
Principal Investigator: Lennart Nilsson, MD, PHD         
Skåne University Hospital Lund Recruiting
Lund, Sweden, 20502
Contact: Ulf Ekelund, MD, PHD       ulf.ekelund@med.lu.se   
Contact: David Erlinge, MD, PHD         
Principal Investigator: Ulf Ekelund, MD, PHD         
Skåne University Hospital Malmö Not yet recruiting
Malmö, Sweden, 20502
Contact: David Erlinge, MD, PHD       david.erlinge@gmail.com   
Contact: Ulf Ekelund, MD, PHD       ulf.ekelund@med.lu.se   
Principal Investigator: David Erlinge, MD, PHD         
Vrinnevi Hospital Norrköping Recruiting
Norrköping, Sweden, 60329
Contact: Christofer Digerfeldt, MD, PHD       Christofer.Digerfeldt@lio.se   
Principal Investigator: Lennart Nilsson, MD, PHD         
Norrtälje Hospital Recruiting
Norrtälje, Sweden, 76129
Contact: Tommy Pettersson, MD       tommy.pettersson@tiohundra.se   
Principal Investigator: Tommy Pettersson, MD         
Skaraborgs Hospital Skövde Not yet recruiting
Skövde, Sweden, 54185
Contact: Per Amandusson, MD       per.amandusson@vgregion.se   
Principal Investigator: Per Amandusson, MD         
St: Göran Hospital Recruiting
Stockholm, Sweden, 11281
Contact: Marianne Erlandsson, MD       Marianne.Erlandsson@capiostgoran.se   
Principal Investigator: Mattias Törnerud, MD         
Danderyds Sjukhus Recruiting
Stockholm, Sweden, 18288
Contact: Rickard Linder, MD, PHD    +46812356122    rickard.linder@ds.se   
Principal Investigator: Rickard Linder, MD, PHD         
Karolinska University Hospital Solna Recruiting
Stockholm, Sweden, 17176
Contact: John Pernow, MD, PHD       john.pernow@ki.se   
Principal Investigator: John Pernow, MD, PHD         
Karolinska University Hospital Huddinge Recruiting
Stockholm, Sweden, 14186
Contact: Tomas Jernberg, MD, PHD       tomas.jernberg@karolinska.se   
Principal Investigator: Tomas Jernberg, MD, PHD         
Södersjukhuset Recruiting
Stockholm, Sweden, 11883
Contact: Robin Hofmann, MD, med dr    +4686162913    robin.hofmann@sodersjukhuset.se   
Contact: Leif Svensson, MD, PHD    +4686161918    leif.svensson@sodersjukhuset.se   
Principal Investigator: Leif Svensson, MD, PHD         
Sub-Investigator: Robin Hofmann, MD         
Härnosand Hospital Sundsvall Recruiting
Sundsvall, Sweden, 85186
Contact: Anna Millbourn, MD       anna.millbourn@lvn.se   
Principal Investigator: Anna Millbourn, MD         
Trelleborg Hospital Recruiting
Trelleborg, Sweden, 23185
Contact: Troels Yndigegn, MD       troels.yndigegn@gmail.com   
Principal Investigator: Troels Yndigegn, MD         
Norrlands University Hospital Recruiting
Umeå, Sweden, 90185
Contact: Krister Lindmark, MD, PHD       Krister.Lindmark@vll.se   
Principal Investigator: Krister Lindmark, MD, PHD         
Uppsala University Hospital Recruiting
Uppsala, Sweden, 75185
Contact: Stefan James, MD, PHD    +46705944404    stefan.james@ucr.uu.se   
Principal Investigator: Stefan James, MD, PHD         
Hallands Hospital Varberg Not yet recruiting
Varberg, Sweden, 43281
Contact: Markus Lingman, MD, PHD       markus.lingman@regionhalland.se   
Principal Investigator: Markus Lingman, MD, PHD         
Växjö Hospital Recruiting
Växjö, Sweden, 35188
Contact: Olle Bergström, MD       olle.p.bergstrom@ltkronoberg.se   
Principal Investigator: Olle Bergström, MD         
Ängelholm Hospital Recruiting
Ängelholm, Sweden, 26281
Contact: Dragisa Barbulovic, MD       dragisa.barbulovic@skane.se   
Principal Investigator: Dragisa Barbulovic, MD         
Örebro University Hospital Recruiting
Örebro, Sweden, 70185
Contact: Thomas Kellerth, MD, PHD       thomas.kellerth@orebroll.se   
Principal Investigator: Thomas Kellerth, MD, PHD         
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: March 27, 2014
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:
Angina, Unstable
Infarction
Myocardial Infarction
Acute Coronary Syndrome
Angina Pectoris
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Ischemia
Pathologic Processes
Necrosis

ClinicalTrials.gov processed this record on July 08, 2014