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| ID | Type | Description | Link |
|---|---|---|---|
| 20241113-3609 | Other Identifier | Medical University Innsbruck |
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To evaluate the hypothesis that a fast discharge strategy (discharge at 24 [± 12] hours) following invasive management for acute myocardial infarction is non-inferior to standard of care (>36 hours) with respect to the risk of major adverse cardiovascular events (MACE) during follow-up.
The goal of this randomized, multicenter trial is to assess the safety of a fast discharge strategy following acute myocardial infarction as compared to standard of care. The trial will evaluate the hypothesis that a fast discharge strategy (discharge at 24 [± 12] hours) following invasive management of acute myocardial infarction is non-inferior to standard of care (discharge >36 hours) with respect to the risk of major adverse cardiovascular events at 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Care | No Intervention | Patients undergo a standard post-infarction care, with discharge at >36 hours after invasive management of acute myocardial infarction. | |
| Fast discharge strategy | Experimental | Fast discharge at 24 (+/-12) hours after invasive management of acute myocardial infarction. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fast discharge strategy | Procedure | Patients undergoing invasive management after myocardial infarction will be discharged after 24 (+/- 12) hours. |
|
| Measure | Description | Time Frame |
|---|---|---|
| MACE | MACE is defined as a composite of all-cause death, myocardial re-infarction and unscheduled cardiovascular re-hospitalization. | From the date of randomization until the first documented event during the follow-up period (up to 12 months). |
| Measure | Description | Time Frame |
|---|---|---|
| All cause death | Death from any cause. | From the date of randomization until the first documented event during the follow-up period (up to 12 months). |
| Number of participants with myocardial re-infarction |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Martin Reindl, MD, PhD | Contact | +43 512 504 25665 | martin.reindl@tirol-kliniken.at | |
| Ivan Lechner, MD, PhD | Contact | ivan.lechner@tirol-kliniken.at |
| Name | Affiliation | Role |
|---|---|---|
| Martin Reindl, MD, PhD | Medical University Innsbruck | Principal Investigator |
| Sebastian J Reinstadler, MD, PhD | Medical University Innsbruck | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Wiener Neustadt | Recruiting | Wiener Neustadt | Lower Austria | 2700 | Austria |
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D000072657 | ST Elevation Myocardial Infarction |
| D000072658 | Non-ST Elevated Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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Number of participants experiencing myocardial re-infarction
| From the date of randomization until the first documented event during the follow-up period (up to 12 months). |
| Number of participants with unscheduled cardiovascular re-hospitalization | Number of participants with unscheduled cardiovascular re-hospitalization | From the date of randomization until the first documented event during the follow-up period (up to 12 months). |
| Number of participants with Cardiovascular death | Number of participants experiencing cardiovascular-related death | From the date of randomization until the first documented event during the follow-up period (up to 12 months). |
| Number of participants hospitalized for heart failure | Number of participants hospitalized for heart failure | From the date of randomization until the first documented event during the follow-up period (up to 12 months). |
| Number of participants expiring hospitalization from any cause | Number of participants expiring hospitalization from any cause | From the date of randomization until the first documented event during the follow-up period (up to 12 months). |
| Number of patients experiencing a stroke | Number of patients experiencing a stroke | From the date of randomization until the first documented event during the follow-up period (up to 12 months). |
| Number of participants with a bleeding event | Number of participants with a bleeding event | From the date of randomization until the first documented event during the follow-up period (up to 12 months). |
| Healthcare costs per patient between randomization and 12 months | An economic evaluation will be conducted from the healthcare payer perspective. Direct healthcare costs, including intervention costs, hospitalizations, outpatient visits, diagnostic procedures, and concomitant medications, will be collected prospectively for each participant over the study period. Mean total healthcare costs per patient will be calculated and compared between study groups. | From the date of randomization until the first documented event during the follow-up period (up to 12 months). |
| Length of hospital stay | Number of days in hospital from time of infarction to hospital discharge | From the date of randomization to the date of hospital discharge, for up to 100 days |
| Percentage of patients on guideline-directed therapy | Percentage of patients on guideline-directed therapy | From the date of randomization until the first documented event during the follow-up period (up to 12 months). |
| Infection | Infection leading to hospitalization | At 30 days |
| Cardinal Schwarzenberg Hospital Schwarzach | Not yet recruiting | Schwarzach im Pongau | Schwarzach Im Pongau | 5620 | Austria |
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| Paracelsus Medical University Salzburg | Recruiting | Salzburg | State of Salzburg | 5020 | Austria |
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| Medical University of Graz | Recruiting | Graz | Styria | 8010 | Austria |
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| Medical University of Innsbruck | Recruiting | Innsbruck | Tyrol | 6020 | Austria |
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| University Teaching Hospital Wels-Grieskirchen | Recruiting | Wels | Upper Austria | 4600 | Austria |
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| Academic Teaching Hospital Feldkirch | Recruiting | Feldkirch | Vorarlberg | 6800 | Austria |
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| Ludwig Maximilian University Munich | Not yet recruiting | Munich | Bavaria | 81377 | Germany |
|
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |