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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Municipal Hospital Ostrava
Sponsor:
Information provided by (Responsible Party):
Kamil Novobílský, Municipal Hospital Ostrava
ClinicalTrials.gov Identifier:
NCT02023983
First received: December 16, 2013
Last updated: April 28, 2014
Last verified: April 2014
  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
Endpoint Classification: Safety Study
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 30 days after myocardial infarction (MI) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Secondary 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 MI [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
  • Complications associated with the puncture site requiring treatment in 30 days after myocardial infarction (MI) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 150
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 30th and 90th day after myocardial infarction
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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 Recruiting
Ostrava, Czech Republic, 728 80
Contact: Kamil Novobílský, M.D.    +420 59 619 2660    k.novobilsky@mnof.cz   
Contact: Radim Kryza, M.D.    +420 59 619 4660    radim.kryza@mnof.cz   
Principal Investigator: Kamil Novobílský, M.D.         
Sponsors and Collaborators
Kamil Novobílský
  More Information

No publications provided

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: April 28, 2014
Health Authority: Czech Republic: Ethics Committee

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

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

ClinicalTrials.gov processed this record on October 22, 2014