DETermination of the Role of OXygen in Suspected Acute Myocardial Infarction (DETO2X-AMI) Based on the SWEDEHEART Registry
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 6,629
- 试验地点
- 34
- 主要终点
- 1-year all-cause mortality
研究概览
简要总结
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.
详细描述
AIM:
The aim of the DETO2X-AMI trial is to evaluate the role of supplemental oxygen delivery in the setting of acute coronary syndrome myocardial infarction including ST-segment elevation myocardial infarction (STEMI), non ST-segment elevation myocardial infarction (NSTEMI) and unstable angina (UA).
DESIGN:
DETO2X-AMI is a multicentre, interventional, controlled, randomized registry based clinical trial (RRCT) recruiting 6600 patients at cardiac care facilities which report into the SWEDEHEART registry throughout the whole of Sweden.
The SWEDEHEART (Swedish Web-system for Enhancement and Development of Evidence-based care in Heart disease Evaluated According to Recommended Therapies) registry is a nationwide used platform allowing a broad population of all-comers access to the broad registry network which includes:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •unwillingness to participate
- •inability to comprehend given information
- •continuous oxygen delivery at home prior to inclusion
- •cardiac arrest prior to inclusion
研究组 & 干预措施
Oxygen
For patients randomised 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
干预措施: Oxygen (Drug)
结局指标
主要结局
1-year all-cause mortality
时间窗: 1 year
1-year all-cause mortality on an intention to treat basis (ITT)
次要结局
- Cardiovascular death(1 year)
- Rehospitalization with AMI(1 year)
- MACE 1(1 year)
- MACE 2(1 year)
- STEMI-PCI-MACE(1 year)
- Health economics(1 year)
- Rehospitalization with heart failure(1 year)
- Rehospitalization with shock (Killip ≥3)(1 year)
研究者
Leif Svensson
Professor of Cardiology
Karolinska Institutet