CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 175 enrolled
Drug / intervention
Oxygendrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02290080
NCT02290080Phase 3Completed

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.

Karolinska Institutet·interventional·Posted Nov 13, 2014·Updated Dec 11, 2017

In Brief

A Phase 3 clinical trial evaluating Oxygen for Acute Myocardial Infarction (AMI) and 5 related conditions. Completed, enrolled 175 participants across 2 sites.

Detailed 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.

Study Details

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedNov 13, 2014
Enrollment StartOct 1, 2014
Primary CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 11.6 years ago

Interventions

Oxygendrug

see arm description