The Effect of Ischemic Postconditioning in Patients With STEMI Undergoing Primary PCI (DANAMI4-iPOST2)
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- ST Segment Elevation Myocardial Infarction
- 发起方
- Rigshospitalet, Denmark
- 入组人数
- 1800
- 试验地点
- 1
- 主要终点
- All cause mortality or hospitalization for heart failure
- 状态
- 招募中
- 最后更新
- 上个月
概览
简要总结
In a prospective, randomized clinical trial the iPOST2 trial will determine whether ischemic postconditioning reduces reperfusion injury and this will translate into improved clinical outcome of heart failure and death for STEMI patients who present with TIMI0-1 undergoing primary PCI
详细描述
Myocardial reperfusion with the use primary percutaneous coronary intervention (PCI) is effective, but restoration of blood flow may itself jeopardize the myocardium, a phenomenon known as reperfusion injury. In ischemic postconditioning (iPOST), repetitive interruptions of blood flow to the injured region applied after initial reperfusion, has been shown favorable with different modalities such as biomarkers, echocardiography and cardiac magnetic resonance. However, the largest trial to date (DANAMI3-iPOST) failed to show clinical favor of iPOST when compared to conventional PCI. Importantly, however, in DANAMI3-iPOST thrombectomy was allowed and this might have impaired postconditioning, since thrombectomy itself creates reperfusion and thus reperfusion damage. Analysis of the fraction of DANAMI3-iPOST patients not undergoing thrombectomy showed a remarkable 45% reduction in death and heart failure in favor of postconditioning. iPOST2 will investigate in a randomized, prospective and adequately powered trial the effect of iPOST without thrombectomy compared to conventional PCI on the development of heart failure and death in STEMI patients.
研究者
Thomas Engstrom
Professor
Rigshospitalet, Denmark
入排标准
入选标准
- •Age ≥18 years
- •Acute onset of chest pain with \< 12 hours duration
- •STEMI as characterized by 2 mm ST elevation in 2 or more V1 through V4 leads or presumed new left bundle branch block with minimum of 1 mm concordant ST elevation or 1 mV ST-segment elevation in the limb lead (II, III and aVF, I, aVL) and V4-V6 or ST depression in 2 or more V1 through V4 leads indicating posterior AMI.
- •TIMI flow 0-1 in infarct related artery
排除标准
- •Potential pregnancy
- •Refusal to participate
- •OHCA without subsequent consciousness despite ROSC
- •Thrombectomy considered unavoidable
结局指标
主要结局
All cause mortality or hospitalization for heart failure
时间窗: From date of randomization until the date of first documented hospitalization for heart failure or date of death from any cause, whichever came first, assessed up to 280 events have been adjudicated or up to 36 months
Composite endpoint of all cause mortality or hospitalization for heart failure which ever occur first
次要结局
- Percentage of patients hospitalized for heart failure(From date of randomization until the date of first documented hospitalization for heart failure assessed up to 280 events have been adjudicated or up to 36 months)
- Percentage of patients with stroke(From date of randomization until the date of first documented hospitalization for heart failure or date of death from any cause, whichever came first, assessed up to 280 events have been adjudicated or up to 36 months)
- All cause mortality(From date of randomization until the date of first documented death from any cause assessed up to 280 events have been adjudicated or up to 36 months)
- Percentage of patients with myocardial infarction(From date of randomization until the date of first documented hospitalization for heart failure or date of death from any cause, whichever came first, assessed up to 280 events have been adjudicated or up to 36 months)
- Percentage of patients with a combination of all-cause mortality, hospitalization for heart failure, new myocardial infarction and stroke/transitory cerebral ischemia(From date of randomization until the date of first documented hospitalization for heart failure or date of death from any cause, whichever came first, assessed up to 280 events have been adjudicated or up to 36 months)
- Cardiovascular death(From date of randomization until the date of first documented hospitalization for heart failure or date of death from any cause, whichever came first, assessed up to 280 events have been adjudicated or up to 36 months)
- Percentage of patients with a combination of hospitalization for heart failure and cardiovascular death(From date of randomization until the date of first documented hospitalization for heart failure or date of death from any cause, whichever came first, assessed up to 280 events have been adjudicated or up to 36 months)
- Danish eq5d5l standard Quality of life(1 year)