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

Coronary Artery Disease Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02023983
• Other study ID #: KN-11-2013
• Status: Completed
• Phase: N/A
• First received: December 16, 2013
• Last updated: October 18, 2017
• Start date: October 2013
• Est. completion date: May 2017

Study information

• Verified date: October 2017
• Source: Municipal Hospital Ostrava
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: May 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Czechia	Municipal Hospital Ostrava	Ostrava

Sponsors (1)

Lead Sponsor	Collaborator
Kamil Novobílský

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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)	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	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