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.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease
- Sponsor
- Kamil Novobílský
- Enrollment
- 151
- Locations
- 1
- Primary Endpoint
- 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)
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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
Investigators
Kamil Novobílský
M.D.
Municipal Hospital Ostrava
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
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)
Time Frame: 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 Outcomes
- Complications Associated With the Puncture Site Requiring Treatment in 30 Days After Myocardial Infarction (MI)(30 days)