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

N/ACompletedNCT02023983

Kamil Novobílský151 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

151

Conditions

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

Interventions

Early dischargeOTHER

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

Standard dischargeOTHER

Discharge after myocardial infarction with ST segment elevation in a standard way accordingly with present practice and physician´s decision (usually 4th-7th day)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Municipal Hospital Ostrava

Ostrava, Czechia

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)

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.

Time frame: 90 days

Secondary Outcomes

Complications Associated With the Puncture Site Requiring Treatment in 30 Days After Myocardial Infarction (MI)

Time frame: 30 days

Data from ClinicalTrials.gov

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