An Efficacy and Outcome Study of Supplemental Oxygen Treatment in Patients With Suspected Myocardial Infarction (DETO₂X-AMI)
This study is currently recruiting participants.
Verified June 2013 by Karolinska Institutet
Sponsor:
Karolinska Institutet
Collaborators:
Swedish Heart Lung Foundation
Swedish Foundation for Strategic Research
Information provided by (Responsible Party):
Leif Svensson, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01787110
First received: February 1, 2013
Last updated: June 13, 2013
Last verified: June 2013
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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 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
|
|
|
Active Comparator: Oxygen
For patients randomised to oxygen therapy:
|
Drug: Oxygen
see arm description
|
Show Detailed Description 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
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 | Recruiting |
| Gothenburg, Sweden, 41345 | |
| Contact: Johan Herlitz, MD, PHD johan.herlitz@bu.se | |
| Principal Investigator: Johan Herlitz, MD, PHD | |
| Gävle Hospital | Not yet recruiting |
| Gävle, Sweden, 80187 | |
| Contact: Lars Svennberg, MD lars.svennberg@lg.se | |
| Principal Investigator: Lars Svennberg, MD | |
| Ryhov Hospital Jönköping | Not yet recruiting |
| Jönköping, Sweden, 55185 | |
| Contact: Jan-Erik Karlsson, MD, PHD Jan-Erik.Karlsson@lj.se | |
| Principal Investigator: Jan-Erik Karlsson, MD, PHD | |
| Karlstad Hospital | Not yet recruiting |
| Karlstad, Sweden, 65185 | |
| Contact: Urban Haaga, MD Urban.Haaga@liv.se | |
| Principal Investigator: Urban Haaga, MD | |
| Kristianstad Hospital | Not yet recruiting |
| Kristianstad, Sweden, 29185 | |
| Contact: Thomas Pettersson, MD thomas.pettersson@skane.se | |
| Principal Investigator: Thomas Pettersson, 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 | Not yet recruiting |
| Norrköping, Sweden, 60329 | |
| Contact: Lennart Nilsson, MD, PHD lennart.nilsson@lio.se | |
| Principal Investigator: Lennart Nilsson, MD, PHD | |
| Norrtälje Hospital | Not yet recruiting |
| Norrtälje, Sweden, 76129 | |
| Contact: Tommy Pettersson, MD tommy.pettersson@tiohundra.se | |
| Principal Investigator: Tommy Pettersson, MD | |
| Karolinska University Hospital Huddinge | Recruiting |
| Stockholm, Sweden, 14186 | |
| Contact: Tomas Jernberg, MD, PHD tomas.jernberg@karolinska.se | |
| Principal Investigator: Tomas Jernberg, MD, PHD | |
| Karolinska University Hospital Solna | Not yet recruiting |
| Stockholm, Sweden, 17176 | |
| Contact: John Pernow, MD, PHD john.pernow@ki.se | |
| Principal Investigator: John Pernow, MD, PHD | |
| Danderyds Sjukhus | Recruiting |
| Stockholm, Sweden, 18288 | |
| Contact: Rickard Linder, MD, PHD +46812356122 rickard.linder@ds.se | |
| Principal Investigator: Rickard Linder, 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 | |
| St: Göran Hospital | Not yet recruiting |
| Stockholm, Sweden, 11281 | |
| Contact: Mattias Törnerud, MD Mattias.Tornerud@capio.se | |
| Principal Investigator: Mattias Törnerud, MD | |
| Trelleborg Hospital | Not yet recruiting |
| Trelleborg, Sweden, 23185 | |
| Contact: Troels Yndigegn, MD troels.yndigegn@gmail.com | |
| Principal Investigator: Troels Yndigegn, MD | |
| Uppsala University Hospital | Recruiting |
| Uppsala, Sweden, 75185 | |
| Contact: Stefan James, MD, PHD +46705944404 stefan.james@ucr.uu.se | |
| Principal Investigator: Stefan James, MD, PHD | |
| Växjö Hospital | Not yet recruiting |
| Växjö, Sweden, 35188 | |
| Contact: Olle Bergström, MD olle.p.bergstrom@ltkronoberg.se | |
| Principal Investigator: Olle Bergström, MD | |
| Ängelholm Hospital | Not yet 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
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: | June 13, 2013 |
| 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 June 17, 2013