Fast Discharge After Acute Myocardial Infarction Discharge MI

NCT ID: NCT06744322

Last Updated: 2025-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

2224 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-01

Study Completion Date

2029-12-31

Brief Summary

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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

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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.

Conditions

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Acute Myocardial Infarction (AMI)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Standard Care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Fast discharge strategy

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

Group Type EXPERIMENTAL

Fast discharge strategy

Intervention Type PROCEDURE

Patients undergoing invasive management after myocardial infarction will be discharged after 24 (+/- 12) hours.

Interventions

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Fast discharge strategy

Patients undergoing invasive management after myocardial infarction will be discharged after 24 (+/- 12) hours.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University Innsbruck

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Martin Reindl, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical University Innsbruck

Sebastian J Reinstadler, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Innsbruck

Locations

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Hospital Wiener Neustadt

Wiener Neustadt, Lower Austria, Austria

Site Status NOT_YET_RECRUITING

Paracelsus Medical University Salzburg

Salzburg, Salzburg, Austria

Site Status RECRUITING

Cardinal Schwarzenberg Hospital Schwarzach

Schwarzach im Pongau, Schwarzach Im Pongau, Austria

Site Status NOT_YET_RECRUITING

Medical University of Graz

Graz, Styria, Austria

Site Status NOT_YET_RECRUITING

Medical University of Innsbruck

Innsbruck, Tyrol, Austria

Site Status RECRUITING

University Teaching Hospital Wels-Grieskirchen

Wels, Upper Austria, Austria

Site Status NOT_YET_RECRUITING

Academic Teaching Hospital Feldkirch

Feldkirch, Vorarlberg, Austria

Site Status NOT_YET_RECRUITING

Ludwig Maximilian University Munich

Munich, Bavaria, Germany

Site Status NOT_YET_RECRUITING

Countries

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Austria Germany

Central Contacts

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Martin Reindl, MD, PhD

Role: CONTACT

+43 512 504 25665

Ivan Lechner, MD, PhD

Role: CONTACT

Facility Contacts

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Franz Xaver Roithinger

Role: primary

Uta Hoppe

Role: primary

Anna Rab

Role: primary

Dirk von Lewinski

Role: primary

Martin Reindl, MD, PhD

Role: primary

+43 512 504 25665

Sebastian J Reinstadler, MD, PhD

Role: backup

Ronald Binder

Role: primary

Matthias Frick

Role: primary

Steffen Massberg

Role: primary

Other Identifiers

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20241113-3609

Identifier Type: OTHER

Identifier Source: secondary_id

1284/2024

Identifier Type: -

Identifier Source: org_study_id

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