Verification of the Safety of Early Discharge in Patients After Acute ST-segment Myocardial Infarction
NCT ID: NCT02023983
Last Updated: 2017-12-06
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
151 participants
INTERVENTIONAL
2013-10-31
2017-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* 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
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Discharge after myocardial infarction with ST segment elevation in a standard way accordingly with present practice and physician´s decision (usually 4th-7th day)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Kamil Novobílský
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Kamil Novobílský
M.D.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Municipal Hospital Ostrava
Ostrava, , Czechia
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
KN-11-2013
Identifier Type: -
Identifier Source: org_study_id