2025-524320-21-00招募中3 期
Prehospital pulse-dose glucocorticoid in patients with STEMI – the PULSE-MI 2 trial
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 5,204
- 试验地点
- 5
- 主要终点
- All-cause mortality
研究概览
简要总结
The aim of the trial is to evaluate the effect of prehospital pulse-dose glucocorticoid on all-cause mortality compared to placebo in patients with STEMI
研究设计
- 分配方式
- Randomized
- 主要目的
- Pulse-mi2
- 盲法
- Double (Subject, Carer, Investigator, Analyst, Monitor)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years including fertile women
- •Acute onset of chest pain with < 24 hours duration
- •STEMI as characterized on electrocardiogram (ECG) by one of the following: a. at least two contiguous leads with ST-segment elevation ≥2.5 mm in men < 40 years, ≥2 mm in men ≥40 years, or ≥1.5 mm in women in leads V2-V3 and/or ≥1 mm in the other leads, b. presumed new left bundle branch block with ≥1 mm concordant ST-segment eleva-tion in leads with a positive QRS complex, or concordant ST-segment depression ≥1 mm in V1-V3, or discordant ST-segment elevation ≥5 mm in leads with a negative QRS complex c. Isolated ST depression ≥0.5 mm in leads V1-V3 and ST-segment elevation (≥0.5 mm) in posterior chest wall leads V7-V9 indicating posterior acute myocardial infarc-tion (AMI) d. ST-segment depression ≥1 mm in eight or more surface leads, coupled with ST-segment elevation in aVR and/or V1 suggesting left main-, or left main equivalent- coronary obstruction
排除标准
- •Suspected other than type I acute myocardial infarction at the time of potential randomization
- •Initial presentation with cardiac arrest (out of hospital cardiac arrest)
- •Known allergy to glucocorticoid
研究组 & 干预措施
SOLU-MEDROL 125 mg pulver och vätska till injektionsvätska, lösning
Test
干预措施: SOLU-MEDROL 125 mg pulver och vätska till injektionsvätska, lösning (Drug)
Natriumchlorid ”Noridem”,solvens til parenteral anvendelse/injektionsvæske, opløsning
Placebo
干预措施: Natriumchlorid ”Noridem”,solvens til parenteral anvendelse/injektionsvæske, opløsning (Drug)
结局指标
主要结局
All-cause mortality
All-cause mortality
次要结局
- Cardiovascular mortality
- Spontaneous myocardial infarction
- Admission for heart failure
- All-cause mortality or admission for heart failure
- Cardiovascular mortality or admission for heart failure
- Recurrent non-fatal cardiovascular events (spontaneous myocardial infarction and admission for heart failure) with death treated as a terminal event
研究者
Thomas Engstrøm
Scientific
Rigshospitalet
研究点 (5)
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