Clinical trial NCT02023983: Verification of the Safety of Early Discharge in Patients After Acute ST-segment Myocardial Infarction
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Acute Myocardial Infarction With ST-segment Elevation
Primary Percutaneous Coronary Intervention
Early Discharge
Keywords: ST-segment elevation myocardial infarction
Primary percutaneous coronary intervention
Low risk
Early discharge
Lead sponsor: Municipal Hospital Ostrava
Sponsor class: OTHER
First posted: 2013-12-30
Enrollment: 151
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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

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

Primary outcomes:
measure: 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)
timeFrame: 90 days
Secondary outcomes:
measure: Complications Associated With the Puncture Site Requiring Treatment in 30 Days After Myocardial Infarction (MI)
timeFrame: 30 days
Other outcomes:
Locations:
city: Ostrava
country: Czechia
facility: Municipal Hospital Ostrava
Study officials:
References:
citation: Novobilsky K, Stipal R, Cerny P, Horak I, Kaucak V, Mrozek J, Vaclavik J, Kryza R. Safety of early discharge in low risk patients after acute ST-segment elevation myocardial infarction, treated with primary percutaneous coronary intervention. Open label, randomized trial. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2019 Feb;163(1):61-66. doi: 10.5507/bp.2018.041. Epub 2018 Aug 28.