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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Kamil Novobílský, Municipal Hospital Ostrava
ClinicalTrials.gov Identifier:
NCT02023983
First received: December 16, 2013
Last updated: December 8, 2016
Last verified: December 2016
  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: Open Label
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 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 ]

Secondary Outcome Measures:
  • Complications associated with the puncture site requiring treatment in 30 days after myocardial infarction (MI) [ Time Frame: 30 days ]

Enrollment: 151
Study Start Date: November 2013
Estimated Study Completion Date: May 2017
Estimated 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 "non-inferior" in comparison 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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02023983

Locations
Czech Republic
Municipal Hospital Ostrava
Ostrava, Czech Republic, 728 80
Sponsors and Collaborators
Kamil Novobílský
  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
Study First Received: December 16, 2013
Last Updated: December 8, 2016

Keywords provided by 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
Ischemia
Pathologic Processes
Necrosis
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on April 24, 2017