Official Title Verification of the Safety of Early Discharge (Within 72 Hours) in Low Risk Patients After Acute ST-segment Elevation Myocardial Infarction Treated With Primary Percutaneous Coronary Intervention. Open Randomized Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 151
- 试验地点
- 2
- 主要终点
- Composite of Incidence of Death, Reinfarction, Unstable Angina Pectoris, Stroke, Unplanned Rehospitalization, Repeat Target Vessel Revascularization and Stent Thrombosis in 90 Days After Myocardial Infarction (MI)
研究概览
简要总结
The aim of the study is to prove that early discharge (within 72 hours) in selected group of patients after myocardial infarction with elevations of ST-segment is feasible and safe
详细描述
The aim of the study is to prove
- that early discharge (within 72 hours) in selected group of patients with low risk of follow-up complications after myocardial infarction with elevations of ST-segment, treated with primary percutaneous coronary intervention, is feasible and safe
- that early discharge is comparable with the group of patients, discharged in a standard way accordingly with present practice and physician´s decision (usually 4th-7th day), thus it is not associated with higher incidence of complications in 90th day after myocardial infarction
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •Age ≥18 do ≤ 75 years
- •Acute myocardial infarction with ST-segment elevation, treated with successful percutaneous coronary intervention within 12 hours from the onset of symptoms
- •Left ventricle ejection fraction ≥ 45% by echocardiography
- •Single- or two-vessel disease (stenosis of major epicardial artery ≥ 70%)
- •Haemodynamic and rhythmic stability (Killip class I, no arrythmia requiring treatment occurring > 2 hours after PCI)
- •Assumed good cooperation and social background
排除标准
- •Symptoms of residual ischemia
- •Significant comorbidities or abnormalities in paraclinical tests, requiring additional evaluation within continuing hospitalization
- •Contraindication of dual antiplatelet therapy or need for anticoagulation therapy
- •Hihg risk of bleeding complications
- •Participation in other clinical study
研究组 & 干预措施
Early discharge
干预措施: Early discharge (Other)
Standard discharge
干预措施: Standard discharge (Other)
结局指标
主要结局
Composite of Incidence of Death, Reinfarction, Unstable Angina Pectoris, Stroke, Unplanned Rehospitalization, Repeat Target Vessel Revascularization and Stent Thrombosis in 90 Days After Myocardial Infarction (MI)
时间窗: 90 days
Fischer´s exact test was used for comparison of qualitative variables between two groups. For comparison of quantitative variables we applied Mann-Whitney U test, respectively Student´s t-test (age). Normality of data was assessed with Shapiro-Wilk test. Values of p \< 0.05 were considered as statistically significant.
次要结局
- Complications Associated With the Puncture Site Requiring Treatment in 30 Days After Myocardial Infarction (MI)(30 days)
研究者
Kamil Novobílský
M.D.
Municipal Hospital Ostrava