Trial Design
DETermination of the role of OXygen in suspected Acute Myocardial Infarction trial

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Background

The use of supplemental oxygen in the setting of suspected acute myocardial infarction (AMI) is recommended 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 are conflicting and fail to clarify the role of supplemental oxygen in AMI.

Methods

A total of 6,600 normoxemic (oxygen saturation [SpO2] ≥90%) patients with suspected AMI will be randomly assigned to either supplemental oxygen 6 L/min delivered by Oxymask (MedCore Sweden AB, Kista, Sweden) for 6 to 12 hours in the treatment group or room air in the control group. Patient inclusion and randomization will take place at first medical contact, either before hospital admission or at the emergency department. The Swedish Web-system for Enhancement and Development of Evidence-based care in Heart disease Evaluated According to Recommended Therapies registry will be used for online randomization, allowing inclusion of a broad population of all-comers. Follow-up will be carried out in nationwide health registries and Swedish Web-system for Enhancement and Development of Evidence-based care in Heart disease Evaluated According to Recommended Therapies. The primary objective is to evaluate whether oxygen reduces 1-year all-cause mortality. Secondary end points include 30-day mortality, major adverse cardiac events, and health economy. Prespecified subgroups include patients with confirmed AMI and certain risk groups. In a 3-month pilot study, the study concept was found to be safe and feasible.

Conclusion

The need to clarify the uncertainty of the role of supplemental oxygen therapy in the setting of suspected AMI is urgent. The DETO2X-AMI trial is designed and powered to address this important issue and may have a direct impact on future recommendations.

Section snippets

Background and rationale

Supplemental oxygen has been used in the setting of suspected acute myocardial infarction (AMI) in prehospital and hospital clinical routine throughout the world for over a century1 and is still included in international treatment guidelines.2, 3 This practice is based on the belief that the administration of supplemental oxygen leads to increased oxygen delivery to the ischemic myocardium and thereby reduces infarct size and subsequent risk of complications such as heart failure and malignant

Registry-based randomized clinical trial—a new trial concept

The DETO2X-AMI trial is a multicenter, prospective, controlled, registry-based randomized clinical trial (RRCT). This trial concept was introduced in the TASTE trial,37 which has now been successfully completed.38 The basis for this concept is the fact that in Sweden, almost all patients with acute ischemic heart disease are registered in the Swedish Web-system for Enhancement and Development of Evidence-based care in Heart disease Evaluated According to Recommended Therapies (SWEDEHEART)

Pilot study

To assess power calculation, logistics, safety, and feasibility before starting a nationwide RRCT, a 3-month pilot study was performed at Södersjukhuset, Stockholm. A total of 129 normooxic patients were enrolled by EMS and at the ED. Except for being younger (median [interquartile range] age 68 [58-78]), baseline characteristics were similar to those seen in the overall SWEDEHEART population (Table). A total of 81 (63%) patients were diagnosed with an AMI (53% NSTEMI and 47% STEMI). Of the

Summary and conclusions

In the first RRCT based on the SWEDEHEART platform, the TASTE trial, all patients were included by a dedicated interventional cardiologist at the catheterization laboratory. In the present study, we will extend the concept of RRCT by including a broader population at first medical contact, engaging several different professions, such as other physicians, nurses, and paramedics in the randomization procedure.

The possible advantages and disadvantages of RRCTs have been discussed in detail

Disclosures

Conflicts of interest: None to declare.

The trial will be conducted in accordance with the Declaration of Helsinki and has been approved by the Regional Ethical Review Board of Gothenburg, Sweden (DETO2X-AMI 2012/287-12).

A prospective, multicenter, controlled, registry-based randomized clinical trial based on the Swedish Web-system for Enhancement and Development of Evidence-based care in Heart disease Evaluated According to Recommended Therapies registry.

Study design, rationale, and pilot study.

Acknowledgements

The members of the DETO2X-AMI Steering Committee are as follows: L. Svensson (chair); J. Herlitz (vice chair); R. Hofmann, Stockholm; N. Witt, Stockholm; S. James, Uppsala; B. Lindahl, Uppsala; D. Erlinge, Lund; and T. Jernberg, Stockholm.

We thank the ambulance staff and personnel at all hospitals participating in the DETO2X-AMI trial for their commitment and unwavering support to this study.

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  • Cited by (0)

    The study is registered at Clinical trial registration: ClinicalTrials.gov (NCT01787110).

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