- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02023983
Verification of the Safety of Early Discharge in Patients After Acute ST-segment Myocardial Infarction
October 18, 2017 updated by: Kamil Novobílský
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.
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Study Type
Interventional
Enrollment (Actual)
151
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Ostrava, Czechia, 728 80
- Municipal Hospital Ostrava
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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
|
Discharge after myocardial infarction with ST segment elevation in a standard way accordingly with present practice and physician´s decision (usually 4th-7th day)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
90 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2013
Primary Completion (Actual)
February 1, 2017
Study Completion (Actual)
May 1, 2017
Study Registration Dates
First Submitted
December 16, 2013
First Submitted That Met QC Criteria
December 23, 2013
First Posted (Estimate)
December 30, 2013
Study Record Updates
Last Update Posted (Actual)
December 6, 2017
Last Update Submitted That Met QC Criteria
October 18, 2017
Last Verified
October 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KN-11-2013
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Coronary Artery Disease
-
Elixir Medical CorporationIstituto Clinico HumanitasActive, not recruitingCoronary Artery Disease | Chronic Total Occlusion of Coronary Artery | Multi Vessel Coronary Artery Disease | Bifurcation of Coronary Artery | Long Lesions Coronary Artery DiseaseItaly
-
Fundación EPICActive, not recruitingCoronary Artery Disease | Left Main Coronary Artery Disease | Left Main Coronary Artery Stenosis | Restenosis, CoronarySpain
-
Peking Union Medical College HospitalNot yet recruitingCoronary Artery Disease | Inflammation | Coronary Artery Disease Progression | Coronary Artery Stenosis | Coronary Artery Restenosis | Inflammatory Disease | Inflammation VascularChina
-
Peking Union Medical College HospitalRecruitingCoronary Artery Disease | Inflammation | Coronary Artery Disease Progression | Coronary Artery Stenosis | Coronary Artery Restenosis | Inflammatory Disease | Inflammation VascularChina
-
IGLESIAS Juan FernandoUniversity of BernNot yet recruiting
-
Barts & The London NHS TrustImperial College London; Brunel UniversityNot yet recruitingCORONARY ARTERY DISEASE
-
National Institutes of Health Clinical Center (CC)National Heart, Lung, and Blood Institute (NHLBI)CompletedCoronary Arteriosclerosis | Coronary Artery Disease (CAD) | Obstructive Coronary Artery DiseaseUnited States
-
Fundación EPICRecruitingCoronary Artery Disease | Coronary Disease | Coronary Occlusion | Left Main Coronary Artery Disease | Coronary Artery StenosisSpain
-
Abbott Medical DevicesCompletedCoronary Artery Disease | Coronary Disease | Coronary Occlusion | Chronic Total Occlusion of Coronary Artery | Coronary Restenosis | Coronary Artery Stenosis | Coronary Artery RestenosisBelgium
-
China National Center for Cardiovascular DiseasesRecruitingLeft Main Coronary Artery DiseaseChina
Clinical Trials on Early discharge
-
Fundació Institut de Recerca de l'Hospital de la...UnknownMyocardial InfarctionSpain
-
Acibadem UniversityCompletedST Elevation Myocardial InfarctionTurkey
-
Bezmialem Vakif UniversityCompleted
-
Fundacion Para La Investigacion Hospital La FeCompleted
-
Oxford University Hospitals NHS TrustEdwards LifesciencesRecruitingHeart Failure | Mitral Regurgitation | Tricuspid Regurgitation | Mitral RepairUnited Kingdom
-
Haukeland University HospitalUniversity of Bergen; Municipality of Bergen, Norway; Kavli Research Centre for...Completed
-
59th Medical WingCompleted
-
Ain Shams UniversityUnknownThe Effect of Early Versus Traditional Hospital Discharge for Women Undergoing Elective Cesarean SectionEgypt
-
Hospital Universitari de BellvitgeUnknownMorbid Obesity | Safety Issues | Sleeve Gastrectomy | Early DischargeSpain