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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02023983
First Posted: December 30, 2013
Last Update Posted: October 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Kamil Novobílský, Municipal Hospital Ostrava
December 16, 2013
December 30, 2013
August 1, 2017
August 30, 2017
October 19, 2017
October 2013
February 2017   (Final data collection date for primary outcome 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) [ Time Frame: 90 days ]
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.
• Composite of incidence of death, reinfarction, unstable angina pectoris, stroke, unplanned rehospitalization, repeat target vessel revascularization and stent thrombosis in 30 days after myocardial infarction (MI) [ Time Frame: 30 days ]
Complete list of historical versions of study NCT02023983 on ClinicalTrials.gov Archive Site
Complications Associated With the Puncture Site Requiring Treatment in 30 Days After Myocardial Infarction (MI) [ Time Frame: 30 days ]
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.
  • Composite of incidence of death, reinfarction, unstable angina pectoris, stroke, unplanned rehospitalization, repeat target vessel revascularization and stent thrombosis in 90 days after MI [ Time Frame: 90 days ]
  • Bleeding complications associated with the puncture site in 30 days after myocardial infarction (MI) [ Time Frame: 30 days ]
Not Provided
Not Provided
 
Verification of the Safety of Early Discharge in Patients After Acute ST-segment Myocardial Infarction
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.
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
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
  • Coronary Artery Disease
  • Acute Myocardial Infarction With ST-segment Elevation
  • Primary Percutaneous Coronary Intervention
  • Early Discharge
  • 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
  • Other: 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)
  • Experimental: Early discharge
    Intervention: Other: Early discharge
  • Active Comparator: Standard discharge
    Intervention: Other: Standard discharge
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
151
May 2017
February 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Czechia
Czech Republic
 
NCT02023983
KN-11-2013
No
Not Provided
Not Provided
Kamil Novobílský, Municipal Hospital Ostrava
Kamil Novobílský
Not Provided
Not Provided
Municipal Hospital Ostrava
September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP