Fast Discharge After Acute Myocardial Infarction Discharge MI

Official title

Fast Discharge After Acute Myocardial Infarction Discharge MI - A Randomized Multicenter Non Inferiority Trial

Overview

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

• Procedure Fast discharge strategy
  Patients undergoing invasive management after myocardial infarction will be discharged after 24 (+/- 12) hours.

Primary outcome measures

• MACE [Time frame: From the date of randomization until the first documented event during the follow-up period (up to 12 months).]

Secondary outcome measures (12)

• All cause death [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: From the date of randomization until the first documented event during the follow-up period (up to 12 months).]
• Length of hospital stay [Time frame: From the date of randomization to the date of hospital discharge, for up to 100 days]
• Percentage of patients on guideline-directed therapy [Time frame: From the date of randomization until the first documented event during the follow-up period (up to 12 months).]
• Infection [Time frame: At 30 days]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Other

Study locations

Austria · 7 centers

• Hospital Wiener Neustadt — Wiener Neustadt
• Cardinal Schwarzenberg Hospital Schwarzach — Schwarzach im Pongau
• Paracelsus Medical University Salzburg — Salzburg
• Medical University of Graz — Graz
• Medical University of Innsbruck — Innsbruck
• University Teaching Hospital Wels-Grieskirchen — Wels
• Academic Teaching Hospital Feldkirch — Feldkirch

Germany · 1 center

• Ludwig Maximilian University Munich — Munich

Identifiers

NCT: NCT06744322 · 1284/2024 · 20241113-3609

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗