Fast Discharge After Acute Myocardial Infarction Discharge MI - A Randomized Multicenter Non Inferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,070
- 试验地点
- 15
- 主要终点
- MACE
研究概览
简要总结
To evaluate the hypothesis that a fast discharge strategy (discharge at 24 [± 12] hours) following invasive management for acute myocardial infarction is non-inferior to standard of care (>36 hours) with respect to the risk of major adverse cardiovascular events (MACE) during follow-up.
详细描述
The goal of this randomized, multicenter trial is to assess the safety of a fast discharge strategy following acute myocardial infarction as compared to standard of care. The trial will evaluate the hypothesis that a fast discharge strategy (discharge at 24 [± 12] hours) following invasive management of acute myocardial infarction is non-inferior to standard of care (discharge >36 hours) with respect to the risk of major adverse cardiovascular events at 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Uncomplicated acute myocardial infarction (NSTEMI and STEMI) diagnosed according to the 2023 acute coronary syndrome guidelines of the ESC
- •Age ≥ 18 years at time of consent
- •Invasive management strategy and in case of PCI successful intervention of the culprit lesion defined by post-interventional TIMI 3 flow
- •Ability to understand and willingness to sign and date written informed consent
排除标准
- •Myocardial infarction complicated by cardiac arrest (out-of-hospital cardiac arrest/in-hospital cardiac arrest)
- •PCI-related complications (coronary perforation, side branch closure, inability to deliver stent/balloon, aortic dissection, allergic reaction grade ≥2, stroke/thromboembolism, access site complications including pseudoaneurysm, arteriovenous fistula, retroperitoneal hemorrhage and arterial dissection/occlusion or emboli)
- •Malignant arrhythmias including sustained ventricular arrhythmias and persistent bradycardia (< 50 beats per minute due to sinus node or atrioventricular conduction system abnormalities, second- /third-degree atrioventricular block) after PCI
- •Ongoing hemodynamic instability (systolic blood pressure <90 mmHg, elevated lactate concentrations, need for inotropes or vasopressors)
- •Ongoing respiratory instability defined by Killip class >I (rales, pulmonary edema)
- •Ongoing quantitative disorders of consciousness (somnolence, sopor, coma)
- •Acute kidney injury defined by Kidney Disease Improving Global Outcomes (KDIGO) stages 2 and 3
- •Pregnancy
- •Untreated critical non-culprit lesions requiring revascularization during index hospitalization not allowing fast discharge
- •Immobility/limited mobility or social circumstances that prevent fast discharge assessed by an interprofessional care team
研究组 & 干预措施
Standard Care
Patients undergo a standard post-infarction care, with discharge at >36 hours after invasive management of acute myocardial infarction.
Fast discharge strategy
Fast discharge at 24 (+/-12) hours after invasive management of acute myocardial infarction.
干预措施: Fast discharge strategy (Procedure)
结局指标
主要结局
MACE
时间窗: From the date of randomization until the first documented event during the follow-up period (up to 12 months).
MACE is defined as a composite of all-cause death, myocardial re-infarction and unscheduled cardiovascular re-hospitalization.
次要结局
- All cause death(From the date of randomization until the first documented event during the follow-up period (up to 12 months).)
- Number of participants with myocardial re-infarction(From the date of randomization until the first documented event during the follow-up period (up to 12 months).)
- Number of participants with unscheduled cardiovascular re-hospitalization(From the date of randomization until the first documented event during the follow-up period (up to 12 months).)
- Number of participants with Cardiovascular death(From the date of randomization until the first documented event during the follow-up period (up to 12 months).)
- Number of participants hospitalized for heart failure(From the date of randomization until the first documented event during the follow-up period (up to 12 months).)
- Number of participants expiring hospitalization from any cause(From the date of randomization until the first documented event during the follow-up period (up to 12 months).)
- Number of patients experiencing a stroke(From the date of randomization until the first documented event during the follow-up period (up to 12 months).)
- Number of participants with a bleeding event(From the date of randomization until the first documented event during the follow-up period (up to 12 months).)
- Healthcare costs per patient between randomization and 12 months(From the date of randomization until the first documented event during the follow-up period (up to 12 months).)
- Length of hospital stay(From the date of randomization to the date of hospital discharge, for up to 100 days)
- Percentage of patients on guideline-directed therapy(From the date of randomization until the first documented event during the follow-up period (up to 12 months).)
- Infection(At 30 days)