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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
The aim of the study is to prove
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early discharge | Experimental |
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| Standard discharge | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early discharge | Other | 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 |
| 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) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Municipal Hospital Ostrava | Ostrava | 728 80 | Czechia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30181666 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Standard Discharge |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 24, 2013 |
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| Standard discharge | Other | Discharge after myocardial infarction with ST segment elevation in a standard way accordingly with present practice and physician´s decision (usually 4th-7th day) |
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| 30 days |
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) |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Hypertension | Count of Participants | Participants |
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| Diabetes | Count of Participants | Participants |
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| Impaired glucose tolerance | Count of Participants | Participants |
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| Hyperliporoteinemia | Count of Participants | Participants |
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| Previous myocardial infarction | Count of Participants | Participants |
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| Previous PCI | Count of Participants | Participants |
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| Previous stroke / transient ischemic attack | Count of Participants | Participants |
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| Peripheral arterial disease | Count of Participants | Participants |
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| Smoking | Count of Participants | Participants |
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| Body-mass index | Mean | Standard Deviation | kg/m^2 |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| 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) | 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. | Posted | Count of Participants | Participants | 90 days |
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| Secondary | 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. | Posted | Count of Participants | Participants | 30 days |
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90 days
Definitions of adverse event and serious adverse event meet the clinicaltrials.gov Definitions
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 0 | 76 | 5 | 76 | 1 | 76 |
| EG001 | 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) | 0 | 75 | 6 | 75 | 0 | 75 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | Non-systematic Assessment |
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| Unstable angina | Cardiac disorders | Non-systematic Assessment |
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| Brain cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
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| Chest pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Radial artery occlusion | Vascular disorders | Non-systematic Assessment |
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The limitation of the study is limited number of probands enrolled in one centre.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| dr. Kamil Novobílský | Municipal Hospital Ostrava | +420 59 619 2660 | k.novobilsky@mnof.cz |
| Sep 5, 2017 |
| Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 24, 2013 | Sep 5, 2017 | ICF_002.pdf |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D009203 | Myocardial Infarction |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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| Between 18 and 65 years |
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| >=65 years |
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| Myocardial infarction |
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| Unstable angina |
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| Unplanned rehospitalization |
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| Repeated target vessel revascularization |
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| Stent thrombosis |
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| Stroke |
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