Back to resultsVerification of the Safety of Early Discharge in Patients After Acute ST-segment Myocardial Infarction
Primary Purpose
Coronary Artery Disease, Acute Myocardial Infarction With ST-segment Elevation, Primary Percutaneous Coronary Intervention
Status
Completed
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Early discharge
Standard discharge
Sponsored by
About this trial
This is an interventional other trial for Coronary Artery Disease focused on measuring ST-segment elevation myocardial infarction, Primary percutaneous coronary intervention, Low risk, Early discharge
Eligibility 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
Sites / Locations
- Municipal Hospital Ostrava
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Early discharge
Standard discharge
Arm Description
Outcomes
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)
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)
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02023983
Brief Title
Verification of the Safety of Early Discharge in Patients After Acute ST-segment Myocardial Infarction
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.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
October 2013 (Actual)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
May 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kamil Novobílský
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Acute Myocardial Infarction With ST-segment Elevation, Primary Percutaneous Coronary Intervention, Early Discharge
Keywords
ST-segment elevation myocardial infarction, Primary percutaneous coronary intervention, Low risk, Early discharge
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
151 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Early discharge
Arm Type
Experimental
Arm Title
Standard discharge
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Early discharge
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Standard discharge
Intervention Description
Discharge after myocardial infarction with ST segment elevation in a standard way accordingly with present practice and physician´s decision (usually 4th-7th day)
Primary Outcome Measure Information:
Title
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)
Description
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.
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Complications Associated With the Puncture Site Requiring Treatment in 30 Days After Myocardial Infarction (MI)
Description
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.
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Municipal Hospital Ostrava
City
Ostrava
ZIP/Postal Code
728 80
Country
Czechia
12. IPD Sharing Statement
Citations:
PubMed Identifier
30181666
Citation
Novobilsky K, Stipal R, Cerny P, Horak I, Kaucak V, Mrozek J, Vaclavik J, Kryza R. Safety of early discharge in low risk patients after acute ST-segment elevation myocardial infarction, treated with primary percutaneous coronary intervention. Open label, randomized trial. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2019 Feb;163(1):61-66. doi: 10.5507/bp.2018.041. Epub 2018 Aug 28.
Results Reference
derived
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Verification of the Safety of Early Discharge in Patients After Acute ST-segment Myocardial Infarction
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