RECRUITINGINTERVENTIONAL
Fast Discharge After Acute Myocardial Infarction Discharge MI
Fast Discharge After Acute Myocardial Infarction Discharge MI - A Randomized Multicenter Non Inferiority Trial
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- Uncomplicated acute myocardial infarction (NSTEMI and STEMI) diagnosed according to the 2023 acute coronary syndrome guidelines of the ESC
- Age ≥ 18 years at time of consent
- Invasive management strategy and in case of PCI successful intervention of the culprit lesion defined by post-interventional TIMI 3 flow
- Ability to understand and willingness to sign and date written willing to sign a consent form
Who Should NOT Join This Trial:
- Myocardial infarction complicated by cardiac arrest (out-of-hospital cardiac arrest/in-hospital cardiac arrest)
- PCI-related complications (coronary perforation, side branch closure, inability to deliver stent/balloon, aortic dissection, allergic reaction grade ≥2, stroke/thromboembolism, access site complications including pseudoaneurysm, arteriovenous fistula, retroperitoneal hemorrhage and arterial dissection/occlusion or emboli)
- Malignant arrhythmias including sustained ventricular arrhythmias and persistent bradycardia (\< 50 beats per minute due to sinus node or atrioventricular conduction system abnormalities, second- /third-degree atrioventricular block) after PCI
- Ongoing hemodynamic instability (systolic blood pressure \<90 mmHg, elevated lactate concentrations, need for inotropes or vasopressors)
- Ongoing respiratory instability defined by Killip class \>I (rales, pulmonary edema)
- Ongoing quantitative disorders of consciousness (somnolence, sopor, coma)
- Acute kidney injury defined by Kidney Disease Improving Global Outcomes (KDIGO) stages 2 and 3
- Pregnancy
- Untreated critical non-culprit lesions requiring revascularization during index hospitalization not allowing fast discharge
- Immobility/limited mobility or social circumstances that prevent fast discharge assessed by an interprofessional care team
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
* Uncomplicated acute myocardial infarction (NSTEMI and STEMI) diagnosed according to the 2023 acute coronary syndrome guidelines of the ESC
* Age ≥ 18 years at time of consent
* Invasive management strategy and in case of PCI successful intervention of the culprit lesion defined by post-interventional TIMI 3 flow
* Ability to understand and willingness to sign and date written informed consent
Exclusion Criteria:
* Myocardial infarction complicated by cardiac arrest (out-of-hospital cardiac arrest/in-hospital cardiac arrest)
* PCI-related complications (coronary perforation, side branch closure, inability to deliver stent/balloon, aortic dissection, allergic reaction grade ≥2, stroke/thromboembolism, access site complications including pseudoaneurysm, arteriovenous fistula, retroperitoneal hemorrhage and arterial dissection/occlusion or emboli)
* Malignant arrhythmias including sustained ventricular arrhythmias and persistent bradycardia (\< 50 beats per minute due to sinus node or atrioventricular conduction system abnormalities, second- /third-degree atrioventricular block) after PCI
* Ongoing hemodynamic instability (systolic blood pressure \<90 mmHg, elevated lactate concentrations, need for inotropes or vasopressors)
* Ongoing respiratory instability defined by Killip class \>I (rales, pulmonary edema)
* Ongoing quantitative disorders of consciousness (somnolence, sopor, coma)
* Acute kidney injury defined by Kidney Disease Improving Global Outcomes (KDIGO) stages 2 and 3
* Pregnancy
* Untreated critical non-culprit lesions requiring revascularization during index hospitalization not allowing fast discharge
* Immobility/limited mobility or social circumstances that prevent fast discharge assessed by an interprofessional care team
Treatments Being Tested
PROCEDURE
Fast discharge strategy
Patients undergoing invasive management after myocardial infarction will be discharged after 24 (+/- 12) hours.
Locations (8)
Hospital Wiener Neustadt
Wiener Neustadt, Lower Austria, Austria
Paracelsus Medical University Salzburg
Salzburg, Salzburg, Austria
Cardinal Schwarzenberg Hospital Schwarzach
Schwarzach im Pongau, Schwarzach Im Pongau, Austria
Medical University of Graz
Graz, Styria, Austria
Medical University of Innsbruck
Innsbruck, Tyrol, Austria
University Teaching Hospital Wels-Grieskirchen
Wels, Upper Austria, Austria
Academic Teaching Hospital Feldkirch
Feldkirch, Vorarlberg, Austria
Ludwig Maximilian University Munich
Munich, Bavaria, Germany