N/A
N=151
Verification of the Safety of Early Discharge in Patients After Acute ST-segment Myocardial Infarction
Coronary Artery Disease · Acute Myocardial Infarction With ST-segment Elevation · Primary Percutaneous Coronary Intervention · Early Discharge
Bottom Line
View on ClinicalTrials.gov: NCT02023983 ↗Enrolled (actual)
151
Serious AEs
7.3%
Results posted
Aug 2017
Primary outcome: Primary: 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) — 5; 6; 0; 0 Participants — p=0.765
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Early discharge (Other); Standard discharge (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Kamil Novobílský
- Primary completion
- Feb 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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) |
5; 6; 0; 0; 1; 2 | 0.765 |
| SECONDARY Complications Associated With the Puncture Site Requiring Treatment in 30 Days After Myocardial Infarction (MI) |
1; 0 | 1 |
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
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
Data sourced from ClinicalTrials.gov (NCT02023983). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.