Fast Discharge After Acute Myocardial Infarction Discharge MI (DISCHARGE-MI)

Medical University Innsbruck

Status: Enrolling

Conditions: Acute Myocardial Infarction (AMI)

Treatments: Procedure: Fast discharge strategy

Study type: Interventional

Funder types: Other

Identifiers

NCT06744322

20241113-3609 (Other Identifier)

1284/2024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,224 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2,224 participants in 2 patient groups

Standard Care

No Intervention group

Description:

Patients undergo a standard post-infarction care, with discharge at 72 (+/-24 hours) after invasive management of acute myocardial infarction.

Fast discharge strategy

Experimental group

Description:

Fast discharge at 24 (+/-12) hours after invasive management of acute myocardial infarction.

Treatment:

Procedure: Fast discharge strategy