Clinical trial NCT06744322: Fast Discharge After Acute Myocardial Infarction Discharge MI
Official title: Fast Discharge After Acute Myocardial Infarction Discharge MI - a Randomized Multicenter Non Inferiority Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Myocardial Infarction (AMI)
Keywords: Myocardial Infarction
STEMI
NSTEMI
Discharge
Randomized
Lead sponsor: Medical University Innsbruck
Sponsor class: OTHER
First posted: 2024-12-20
Enrollment: 2224
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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 (72 \[± 24\] hours) with respect to the risk of major adverse cardiovascular events (MACE) at 12 months.

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 at 72 \[± 24\] hours) with respect to the risk of major adverse cardiovascular events at 12 months.

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
* Absence of 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)
* 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)
* 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)
* Pregnancy
* Immobility/limited mobility or social circumstances that prevent fast discharge assessed by an interprofessional care team

Primary outcomes:
measure: MACE
timeFrame: At 12 months
Secondary outcomes:
measure: All cause death
timeFrame: At 30 days at 12 months
measure: Myocardial re-infarction
timeFrame: At 30 days and 12 months
measure: Unscheduled cardiovascular re-hospitalization
timeFrame: At 30 and12 months
measure: Cardiovascular death
timeFrame: At 30 days and 12 months
measure: Heart failure hospitalization
timeFrame: At 30 days and 12 months
measure: Stroke
timeFrame: At 30 days and 12 months
measure: Bleeding events
timeFrame: At 30 days and 12 months
measure: Cost-effectiveness
timeFrame: At 12 months
measure: Length of hospital stay
timeFrame: Hospitalization
measure: Percentage of patients on guideline-directed therapy
timeFrame: At 30 days and 12 months.
Other outcomes:
Locations:
city: Wiener Neustadt
country: Austria
facility: Hospital Wiener Neustadt
state: Niederösterreich
city: Wels
country: Austria
facility: University Teaching Hospital Wels-Grieskirchen
state: Oberösterreich
city: Graz
country: Austria
facility: Medical University of Graz
state: Steiermark
city: Innsbruck
country: Austria
facility: Medical University of Innsbruck
state: Tyrol
city: Feldkirch
country: Austria
facility: Academic Teaching Hospital Feldkirch
state: Vorarlberg
city: Salzburg
country: Austria
facility: Paracelsus Medical University Salzburg
city: Schwarzach im Pongau
country: Austria
facility: Cardinal Schwarzenberg Hospital Schwarzach
city: Munich
country: Germany
facility: Ludwig Maximilian University Munich
state: Bayern
Study officials:
affiliation: Medical University Innsbruck
name: Martin Reindl, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: