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Determination of the Role of Oxygen in Suspected Acute Myocardial Infarction by Biomarkers (DETO2X-bio)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02290080
Recruitment Status : Completed
First Posted : November 13, 2014
Last Update Posted : December 11, 2017
University Hospital, Linkoeping
Information provided by (Responsible Party):
Leif Svensson, Karolinska Institutet

Brief Summary:

Oxygen treatment is widely used in acutely ill patients, both pre-hospital and in hospital. The indication for oxygen is sometimes unquestionable, such as in many hypoxic patients, but in other situations its use is more of a practise and much less based on scientific evidence. In particular, oxygen treatment is routinely used in patients with a suspected heart attack and variably recommended in guidelines, despite very limited data supporting a beneficial effect. Indeed, a few studies even indicate that oxygen treatment might be harmful.

Immediate re-opening of the acutely blocked artery to the heart muscle is the treatment of choice to limit permanent injury. However, the sudden re-initiation of blood flow achieved with primary percutaneous coronary intervention (PCI), the reopening and stenting of the blocked vessel, can give rise to further endothelial and myocardial damage, so-called reperfusion injury. Ischemia and reperfusion associated myocardial injury (IR-injury) involves a wide range of pathological processes. Vascular leakage, activation of cell death programs, thrombocytes and white blood cells leading to extended inflammation and formation of clots are examples of those effects.

The role of oxygen treatment on these pathological processes, on the extent of IR-injury and the final infarct size in patients with acute myocardial infarctions (AMI) has not previously been studied.

In an ongoing national multicentre, randomized, registry based clinical trial, the DETO2X-AMI trial (NCT01787110), the effect of oxygen on morbidity and mortality in ACS patients is being investigated.

The present DETO2X-biomarkers study is a substudy of the DETO2X-AMI trial, evaluating the effect of oxygen treatment on biological systems involved in the pathogenesis of reversible and irreversible myocardial damage and cell death in ACS.

Condition or disease Intervention/treatment Phase
Acute Myocardial Infarction (AMI) Acute Coronary Syndrome (ACS) ST Elevation (STEMI) Myocardial Infarction Ischemic Reperfusion Injury Non-ST Elevation (NSTEMI) Myocardial Infarction Angina, Unstable Drug: Oxygen Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 175 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Determination of the Role of Oxygen on Mechanisms Involved in Ischemia-reperfusion Injury in Suspected Acute Myocardial Infarction by Biomarkers. A Sub Study to the DETO2X-AMI Trial.
Actual Study Start Date : October 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Oxygen

For patients randomized 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

No Intervention: No oxygen

For patients randomized 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

Primary Outcome Measures :
  1. Plasma concentration levels over time of biomarkers of oxidative stress, apoptosis, inflammation and platelet aggregation [ Time Frame: Within 8hours from baseline ]

    Venous blood samples will be collected at baseline and 5-7 hours after baseline. Plasma concentration levels will be analyzed for Interleukin (IL)-6 [pg/mL], CRP [mg/L], Isoprostane [pg/mL], Soluble TNF receptor 1 [pg/mL], Soluble TNF receptor 2 [pg/mL], Soluble Fas [pg/mL], Soluble Fas ligand (pg/mL], MMP-2 [ng/mL], TIMP-2 [ng/mL], Soluble P-selectin [ng/mL], Platelet factor (PF)-4 [ng/mL], Beta-thromboglobulin [ng/mL].

    Optional, flow cytometry will be used to analyse neutrophil integrin receptors (CD11b/CD18) and platelet-leukocyte aggregates (CD41a/CD11b/CD45) in whole blood. Whole blood will be fixated and red blood cells lysed before analysis.

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 emergency department 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02290080

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Linköping University Hospital
Linköping, Sweden, 58191
Stockholm, Sweden, 11883
Sponsors and Collaborators
Karolinska Institutet
University Hospital, Linkoeping
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Principal Investigator: Lennart Lennart, MD, PHD Department of Medical and Health Sciences, Linköping University, and Department of Cardiology, University Hospital, 58185 Linköping, Sweden
Additional Information:
Publications of Results:
Other Publications:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Leif Svensson, MD, PHD, Karolinska Institutet Identifier: NCT02290080    
Other Study ID Numbers: DETO2X-biomarkers 2012/287-12
First Posted: November 13, 2014    Key Record Dates
Last Update Posted: December 11, 2017
Last Verified: December 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Leif Svensson, Karolinska Institutet:
acute myocardial infarction (AMI)
acute coronary syndrome (ACS)
ST-segment elevation myocardial infarction (STEMI)
Non ST-segment elevation myocardial infarction (NSTEMI)
Ischemic Reperfusion injury (IR-injury)
Fluorescence-activated cell sorting (FACS)
Flow cytometry
Matrix metalloproteinase (MMP)
Additional relevant MeSH terms:
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Myocardial Infarction
Acute Coronary Syndrome
Reperfusion Injury
Angina, Unstable
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Postoperative Complications
Angina Pectoris
Chest Pain
Neurologic Manifestations