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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
Results First Submitted: August 1, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Conditions: Coronary Artery Disease
Acute Myocardial Infarction With ST-segment Elevation
Primary Percutaneous Coronary Intervention
Early Discharge
Interventions: Other: Early discharge
Other: Standard discharge

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Early Discharge 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 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)

Participant Flow:   Overall Study
    Early Discharge   Standard Discharge
STARTED   76   75 
COMPLETED   76   75 
NOT COMPLETED   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Early Discharge 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 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)
Total Total of all reporting groups

Baseline Measures
   Early Discharge   Standard Discharge   Total 
Overall Participants Analyzed 
[Units: Participants]
 76   75   151 
Age 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 76   75   151 
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      58  76.3%      56  74.7%      114  75.5% 
>=65 years      18  23.7%      19  25.3%      37  24.5% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 76   75   151 
Female      15  19.7%      12  16.0%      27  17.9% 
Male      61  80.3%      63  84.0%      124  82.1% 
Race and Ethnicity Not Collected [1] 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 0   0   0 
         0 
[1] Race and Ethnicity were not collected from any participant.
Hypertension 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 76   75   151 
   41   41   82 
Diabetes 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 76   75   151 
   7   7   14 
Impaired glucose tolerance 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 76   75   151 
   8   12   20 
Hyperliporoteinemia 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 76   75   151 
   54   58   112 
Previous myocardial infarction 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 76   75   151 
   3   6   9 
Previous PCI 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 76   75   151 
   2   6   8 
Previous stroke / transient ischemic attack 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 76   75   151 
   2   2   4 
Peripheral arterial disease 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 76   75   151 
   2   1   3 
Smoking 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 76   75   151 
   56   45   101 
Body-mass index 
[Units: Kg/m^2]
Mean (Standard Deviation)
     
Participants Analyzed 
[Units: Participants]
 76   75   151 
   29.9  (5.1)   27.3  (3.5)   28.64  (4.3) 


  Outcome Measures
  Show All Outcome Measures

1.  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)   [ Time Frame: 90 days ]

2.  Secondary:   Complications Associated With the Puncture Site Requiring Treatment in 30 Days After Myocardial Infarction (MI)   [ Time Frame: 30 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The limitation of the study is limited number of probands enrolled in one centre.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: dr. Kamil Novobílský
Organization: Municipal Hospital Ostrava
phone: +420 59 619 2660
e-mail: k.novobilsky@mnof.cz



Responsible Party: Kamil Novobílský, 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