Trial DesignDETermination of the role of OXygen in suspected Acute Myocardial Infarction trial
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.
References (49)
- et al.
Effect of 100% oxygen administration on infarct size and left ventricular function in a canine model of myocardial infarction and reperfusion
Am Heart J
(1995) - et al.
Acute myocardial infarction with hyperoxemic therapy (AMIHOT)—a prospective, randomized trial of intracoronary hyperoxemic reperfusion after percutaneous coronary intervention
Journal of the American College of Cardiology
(2007) - et al.
The effects of inhalation of 100 percent oxygen on myocardial lactate metabolism in coronary heart disease
Am J Cardiol
(1969) - et al.
Correcting arterial hypoxemia by oxygen therapy in patients with acute myocardial infarction. Effect on ventilation and hemodynamics
Am J Cardiol
(1969) - et al.
Revisiting the role of oxygen therapy in cardiac patients
J Am Coll Cardiol
(2010) - et al.
Effect of hyperoxia on left ventricular function and filling pressures in patients with and without congestive heart failure
Chest
(2001) - et al.
Predictors of coronary stent thrombosis: The Dutch Stent Thrombosis Registry
J Am Coll Cardiol
(2009) Oxygen therapy for acute myocardial infarction—then and now. A century of uncertainty
Am J Med
(2011)- et al.
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) - et al.
Predictive value of the index of microcirculatory resistance in patients with ST-segment elevation myocardial infarction
J Am Coll Cardiol
(2008)
The index of microcirculatory resistance measured acutely predicts the extent and severity of myocardial infarction in patients with ST-segment elevation myocardial infarction
JACC Cardiovasc Interv
Characteristics of and outcome for patients with chest pain in relation to transport by the emergency medical services in a 20-year perspective
Am J Emerg Med
Patients admitted to hospital with chest pain—changes in a 20-year perspective
Int J Cardiol
Rescuing clinical trials in the United States and beyond: a call for action
Am Heart J
High-concentration versus titrated oxygen therapy in ST-elevation myocardial infarction: a pilot randomized controlled trial
Am Heart J
Severe angina pectoris relieved by oxygen inhalations
BMJ
ESC guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation
Eur Heart J
ESC guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation
Eur Heart J
Reduction of infarct size by oxygen inhalation following acute coronary occlusion
Circulation
Precordial ST-segment mapping. 2. Effects of oxygen inhalation on ischemic injury in patients with acute myocardial infarction
Circulation
Hyperbaric oxygen and thrombolysis in myocardial infarction: the “HOT M” randomized multicenter study
Cardiology
Effect of supersaturated oxygen delivery on infarct size after percutaneous coronary intervention in acute myocardial infarction
Circ-Cardiovasc Intervent
Coronary hemodynamics and myocardial oxygen metabolism during oxygen breathing in patients with and without coronary artery disease
Circulation
Circulatory and metabolic effects of oxygen in myocardial infarction
Br Med J
Cited by (0)
The study is registered at Clinical trial registration: ClinicalTrials.gov (NCT01787110).