Acute Myocardial Infarction (AMI)
Conditions
Keywords
Myocardial Infarction, STEMI, NSTEMI, Discharge, Randomized
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREFast discharge strategy
Patients undergoing invasive management after myocardial infarction will be discharged after 24 (+/- 12) hours.
Sponsors
Medical University Innsbruck
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MACE | From the date of randomization until the first documented event during the follow-up period (up to 12 months). | MACE is defined as a composite of all-cause death, myocardial re-infarction and unscheduled cardiovascular re-hospitalization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All cause death | From the date of randomization until the first documented event during the follow-up period (up to 12 months). | Death from any cause. |
| Number of participants with 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 experiencing myocardial re-infarction |
| 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 unscheduled cardiovascular re-hospitalization |
| Number of participants with Cardiovascular death | From the date of randomization until the first documented event during the follow-up period (up to 12 months). | Number of participants experiencing cardiovascular-related death |
| 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 hospitalized for heart failure |
| 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 participants expiring hospitalization from any cause |
| 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 patients experiencing a stroke |
| 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). | Number of participants with a bleeding event |
| Healthcare costs per patient between randomization and 12 months | From the date of randomization until the first documented event during the follow-up period (up to 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. |
| Length of hospital stay | From the date of randomization to the date of hospital discharge, for up to 100 days | Number of days in hospital from time of infarction to hospital discharge |
| 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). | Percentage of patients on guideline-directed therapy |
| Infection | At 30 days | Infection leading to hospitalization |
Countries
Austria, Germany
Contacts
CONTACTMartin Reindl, MD, PhD
CONTACTIvan Lechner, MD, PhD
PRINCIPAL_INVESTIGATORMartin Reindl, MD, PhD
Medical University Innsbruck
PRINCIPAL_INVESTIGATORSebastian J Reinstadler, MD, PhD
Medical University of Innsbruck
Outcome results
None listed