Verification of the Safety of Early Discharge in Patients After Acute ST-segment Myocardial Infarction
- Conditions
- Coronary Artery DiseaseEarly DischargeAcute Myocardial Infarction With ST-segment ElevationPrimary Percutaneous Coronary Intervention
- Interventions
- Other: Standard dischargeOther: Early discharge
- Registration Number
- NCT02023983
- Lead Sponsor
- Kamil Novobílský
- Brief Summary
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
- Detailed Description
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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 151
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard discharge Standard discharge - Early discharge Early discharge -
- Primary Outcome Measures
Name Time Method 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) 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.
- Secondary Outcome Measures
Name Time Method Complications Associated With the Puncture Site Requiring Treatment in 30 Days After Myocardial Infarction (MI) 30 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.
Trial Locations
- Locations (1)
Municipal Hospital Ostrava
🇨🇿Ostrava, Czechia