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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: December 6, 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
  Purpose
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

Condition Intervention
Coronary Artery Disease Acute Myocardial Infarction With ST-segment Elevation Primary Percutaneous Coronary Intervention Early Discharge Other: Early discharge Other: Standard discharge

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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.

Resource links provided by NLM:


Further study details as provided by Kamil Novobílský, Municipal Hospital Ostrava:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 151
Actual Study Start Date: October 2013
Study Completion Date: May 2017
Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
Active Comparator: Standard discharge 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)

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02023983


Locations
Czechia
Municipal Hospital Ostrava
Ostrava, Czechia, 728 80
Sponsors and Collaborators
Kamil Novobílský
  Study Documents (Full-Text)

Documents provided by Kamil Novobílský, Municipal Hospital Ostrava:
Informed Consent Form  [PDF] September 5, 2017

  More Information

Responsible Party: Kamil Novobílský, M.D., Municipal Hospital Ostrava
ClinicalTrials.gov Identifier: NCT02023983     History of Changes
Other Study ID Numbers: KN-11-2013
First Submitted: December 16, 2013
First Posted: December 30, 2013
Results First Submitted: August 1, 2017
Results First Posted: August 30, 2017
Last Update Posted: December 6, 2017
Last Verified: October 2017

Keywords provided by Kamil Novobílský, Municipal Hospital Ostrava:
ST-segment elevation myocardial infarction
Primary percutaneous coronary intervention
Low risk
Early discharge

Additional relevant MeSH terms:
Infarction
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Myocardial Infarction
ST Elevation Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases