Fast Discharge After Acute Myocardial Infarction Discharge MI

Not Applicable

Recruiting

• Conditions: Acute Myocardial Infarction (AMI)

• Registration Number: NCT06744322
• Lead Sponsor: Medical University Innsbruck

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.

Study Timeline

• Status Verified: 2024-11
• Study Start: 2024-12-01
• Study First Submitted: 2024-12-13
• Study First Submitted QC: 2024-12-19
• Last Update Submitted: 2024-12-19
• Study First Posted: 2024-12-20
• Last Update Posted: 2024-12-20
• Primary Completion: 2029-12-31
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2224

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
MACE	At 12 months	MACE is defined as a composite of all-cause death, myocardial re-infarction and unscheduled cardiovascular re-hospitalization.

Secondary Outcome Measures

Name	Time	Method
All cause death	At 30 days at 12 months	Death from any cause.
Myocardial re-infarction	At 30 days and 12 months	Number of patients experiencing myocardial re-infarction
Unscheduled cardiovascular re-hospitalization	At 30 and12 months	Unscheduled cardiovascular re-hospitalization
Cardiovascular death	At 30 days and 12 months	Number of patients experiencing cardiovascular-related death
Heart failure hospitalization	At 30 days and 12 months	Number of patients hospitalized for heart failure
Stroke	At 30 days and 12 months	Number of patients experiencing a stroke
Bleeding events	At 30 days and 12 months	Number of bleeding events at 12 months
Cost-effectiveness	At 12 months	Cost-effectiveness measurements
Length of hospital stay	Hospitalization	Number of days in hospital from time of infarction to hospital discharge
Percentage of patients on guideline-directed therapy	At 30 days and 12 months.	Percentage of patients on guideline-directed therapy

Trial Locations

Locations (8)

Hospital Wiener Neustadt; 🇦🇹 Wiener Neustadt, Niederösterreich, Austria

University Teaching Hospital Wels-Grieskirchen; 🇦🇹 Wels, Oberösterreich, Austria

Medical University of Graz; 🇦🇹 Graz, Steiermark, Austria

Medical University of Innsbruck; 🇦🇹 Innsbruck, Tyrol, Austria

Academic Teaching Hospital Feldkirch; 🇦🇹 Feldkirch, Vorarlberg, Austria

Paracelsus Medical University Salzburg; 🇦🇹 Salzburg, Austria

Cardinal Schwarzenberg Hospital Schwarzach; 🇦🇹 Schwarzach im Pongau, Austria

Ludwig Maximilian University Munich; 🇩🇪 Munich, Bayern, Germany