Cost-effectiveness of Remote Ischemic Conditioning as an Adjunct to Primary Percutaneous Coronary Intervention in Patients With ST-elevation Myocardial Infarction
试验速览
- 阶段
- 不适用
- 入组人数
- 333
- 试验地点
- 2
- 主要终点
- Incremental cost-effectiveness ratio (ICER) = [difference in total cardiovascular medical care costs between treatment groups] / [difference in major adverse cardiac and cerebrovascular event (MACCE)-free survival between treatment groups]
研究概览
简要总结
The aim of this study is to investigate the cost-effectiveness of remote ischemic conditioning as an adjunct to primary percutaneous coronary intervention from the perspective of a Danish healthcare system.
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
- Single (Outcomes Assessor)
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
- •(1) age ≥ 18 years, (2) symptom duration of ≤ 12 hours prior to admission, and (3) ST-segment elevation ≥ 0.1 mV in two or more contiguous electrocardiogram (ECG) leads
排除标准
- •(1) diagnosis not confirmed during hospital admission, (2) history of previous myocardial infarction, (3) previous CABG, and (4) chest pain > 12 hours prior to admission
研究组 & 干预措施
Intervention group
Remote ischemic conditioning through intermittent arm ischemia with four cycles of alternating 5-minute inflation followed by 5-minute deflation of a blood pressure cuff performed in the ambulance during transport to primary percutaneous coronary intervention.
干预措施: Remote ischemic conditioning (Procedure)
Control group
Standard treatment with primary percutaneous coronary intervention alone.
结局指标
主要结局
Incremental cost-effectiveness ratio (ICER) = [difference in total cardiovascular medical care costs between treatment groups] / [difference in major adverse cardiac and cerebrovascular event (MACCE)-free survival between treatment groups]
时间窗: 4-years of follow-up
Data for the economic evaluation are collected from Danish nationwide registries and validated with medical record review. Charges from the Diagnosis Related Group (DRG) and the Danish Ambulatory Grouping System /DAGS) are used to calculate total cardiovascular medical care costs in the two treatment groups.
次要结局
未报告次要终点