NCT04775914招募中不适用
The STEMI Optimization Trial - Ischemic Postconditioning (DANAMI4-iPOST) and Intravascular Ultrasound Guided PCI in STEMI (DANAMI4-iSTEMI)
Thomas Engstrom1 个研究点 分布在 1 个国家目标入组 2,500 人开始时间: 2021年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,500
- 试验地点
- 1
- 主要终点
- iPOST
研究概览
简要总结
The purpose of is study is to investigate whether ischemic postconditioning (iPOST) and intravascular ultrasound-guided (IVUS) percutaneous coronary intervention (PCI) improve the clinical outcome of patients with ST-segment elevation myocardial infarction treated with primary PCI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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.
排除标准
- •Pre-PCI TIMI flow 0 or 1 Potential pregnancy Inability to provide informed consent Unwillingness to consent Unavoidable to use thrombectomy Spontaneous coronary artery dissection Time from symptoms onset to PPCI > 12 hours Culprit in bypass graft Other reason for not including the patient
- •Exclusion Criteria (iSTEMI):
- •Potential pregnancy Inability to understand information in order to provide informed consent Unwillingness to consent Spontaneous coronary artery dissection Time from symptoms inset to PPCI > 12 hours Culprit in bypass graft Other reason
结局指标
主要结局
iPOST
时间窗: Until expected number of events are adjudicated up til 3 years
Number of participants that experience all-cause mortality or hospitalization for heart failure
iSTEMI (IVUS)
时间窗: Until expected number of events are adjudicated up til 3 years
Number of participants that experience all-cause mortality, unplanned ischemia-driven revascularization and new myocardial infarction
次要结局
- iPOST(1 year)
- iSTEMI (IVUS)(Until expected number of events are adjudicated 3 years)
- iPOST(Until expected number of events are adjudicated 3 years)
研究者
Thomas Engstrom
Professor
Rigshospitalet, Denmark
研究点 (1)
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