Verification of the Safety of Early Discharge in Patients After Acute ST-segment Myocardial Infarction

Study Overview
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Brief Summary
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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
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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

Official Title
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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.

Conditions
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Coronary Artery Disease, Acute Myocardial Infarction With ST-segment Elevation, Primary Percutaneous Coronary Intervention, Early Discharge

Intervention / Treatment
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* Other: Early discharge
* Other: Standard discharge


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early discharge<br> | Other: Early discharge<br>* Early discharge (within 72 hours) of selected patients with low risk of complications after myocardial infarction with ST segment elevation, treated with successful percutaneous coronary intervention<br>|
| Active Comparator: Standard discharge<br> | Other: Standard discharge<br>* Discharge after myocardial infarction with ST segment elevation in a standard way accordingly with present practice and physician´s decision (usually 4th-7th day)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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. | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications Associated With the Puncture Site Requiring Treatment in 30 Days After Myocardial Infarction (MI) | 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. | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ST-segment elevation myocardial infarction, Primary percutaneous coronary intervention, Low risk, Early discharge