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

December 8, 2017 updated by: Leif Svensson, Karolinska Institutet

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

6629

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Enköping, Sweden, 74525
        • Enköping Hospital
      • Gothenburg, Sweden, 41345
        • Gothenburg University Hospital, Sahlgrenska
      • Gothenburg, Sweden, 41345
        • Gothenburg University Hospital, Östra
      • Gävle, Sweden, 80187
        • Gävle hospital
      • Halmstad, Sweden, 30185
        • Hallands Hospital Halmstad
      • Jönköping, Sweden, 55185
        • Ryhov Hospital Jönköping
      • Kalmar, Sweden, 39185
        • Kalmar Regional Hospital
      • Karlstad, Sweden, 65185
        • Karlstad hospital
      • Kiruna, Sweden, 98131
        • Kiruna Hospital
      • Kristianstad, Sweden, 29185
        • Kristianstad Hospital
      • Köping, Sweden, 73130
        • Köping Hospital
      • Lidköping, Sweden
        • Skaraborgs Hospital Lidköping
      • Linköping, Sweden, 58191
        • Linköping University Hospital
      • Lund, Sweden, 20502
        • Skane University Hospital Lund
      • Malmö, Sweden, 20502
        • Skåne University Hospital Malmö
      • Mölndal, Sweden, 41345
        • Sahlgrenska Universitetssjukhus Mölndal
      • Norrköping, Sweden, 60329
        • Vrinnevi Hospital Norrköping
      • Norrtälje, Sweden, 76129
        • Norrtälje Hospital
      • Nyköping, Sweden, 61185
        • Nyköping Hospital
      • Skövde, Sweden, 54185
        • Skaraborgs Hospital Skövde
      • Stockholm, Sweden, 11883
        • Södersjukhuset
      • Stockholm, Sweden, 14186
        • Karolinska University Hospital Huddinge
      • Stockholm, Sweden, 11281
        • St: Göran Hospital
      • Stockholm, Sweden, 17176
        • Karolinska University Hospital Solna
      • Stockholm, Sweden, 18288
        • Danderyds Sjukhus
      • Sundsvall, Sweden, 85186
        • Härnosand Hospital Sundsvall
      • Trelleborg, Sweden, 23185
        • Trelleborg Hospital
      • Umeå, Sweden, 90185
        • Norrlands University Hospital
      • Uppsala, Sweden, 75185
        • Uppsala University Hospital
      • Varberg, Sweden, 43281
        • Hallands Hospital Varberg
      • Växjö, Sweden, 35188
        • Växjö Hospital
      • Örebro, Sweden, 70185
        • Orebro University Hospital
      • Örnsköldsvik, Sweden, 89189
        • Örnsköldsvik hospital
      • Östersund, Sweden, 83183
        • Östersund Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1-year all-cause mortality
Time Frame: 1 year
1-year all-cause mortality on an intention to treat basis (ITT)
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MACE 1
Time Frame: 1 year
All-cause mortality or rehospitalization with heart failure at 1-year
1 year
MACE 2
Time Frame: 1 year
All-cause mortality or rehospitalization with heart failure or readmission with myocardial infarction at 1-year
1 year
STEMI-PCI-MACE
Time Frame: 1 year
All-cause death or rehospitalization with MI or cardiogenic shock or stent thrombosis at one year
1 year
Rehospitalization with heart failure
Time Frame: 1 year
Rehospitalization with heart failure at 1-year
1 year
Rehospitalization with AMI
Time Frame: 1 year
Rehospitalization with AMI at 1-year
1 year
Rehospitalization with shock (Killip ≥3)
Time Frame: 1 year
Rehospitalization with shock (Killip ≥3) at 1-year
1 year
Cardiovascular death
Time Frame: 1 year
Cardiovascular death at 1-year
1 year
Health economics
Time Frame: 1 year
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Collaborators

The Swedish Research Council
Swedish Heart Lung Foundation
Swedish Foundation for Strategic Research

Investigators

  • Study Director: Leif Svensson, MD, PHD, Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2013

Primary Completion (Actual)

December 30, 2016

Study Completion (Actual)

December 30, 2016

Study Registration Dates

First Submitted

February 1, 2013

First Submitted That Met QC Criteria

February 6, 2013

First Posted (Estimate)

February 8, 2013

Study Record Updates

Last Update Posted (Actual)

December 11, 2017

Last Update Submitted That Met QC Criteria

December 8, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DETO2X-AMI 2012/287-12

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acute Coronary Syndrome

Clinical Trials on Oxygen

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tanzania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe