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

March 11, 2026 updated by: Medical University Innsbruck

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2070

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Austria
    • Lower Austria
    • Salzburg
      • Salzburg, Salzburg, Austria, 5020
        • Recruiting
        • Paracelsus Medical University Salzburg
        • Contact:
    • Schwarzach Im Pongau
      • Schwarzach im Pongau, Schwarzach Im Pongau, Austria, 5620
    • Styria
    • Tyrol
      • Innsbruck, Tyrol, Austria, 6020
        • Recruiting
        • Medical University of Innsbruck
        • Contact:
        • Contact:
        • Principal Investigator:
          • Martin Reindl, MD, PhD
        • Principal Investigator:
          • Sebastian J Reinstadler, MD, PhD
        • Sub-Investigator:
          • Ivan Lechner, MD, PhD
        • Sub-Investigator:
          • Alex Kaser, MD
    • Upper Austria
      • Wels, Upper Austria, Austria, 4600
    • Vorarlberg
      • Feldkirch, Vorarlberg, Austria, 6800
  • Germany

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Fast discharge strategy
Fast discharge at 24 (+/-12) hours after invasive management of acute myocardial infarction.
Procedure: Fast discharge strategy
Patients undergoing invasive management after myocardial infarction will be discharged after 24 (+/- 12) hours.
No Intervention: Standard Care
Patients undergo a standard post-infarction care, with discharge at >36 hours after invasive management of acute myocardial infarction.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
MACE
Time Frame: From the date of randomization until the first documented event during the follow-up period (up to 12 months).
MACE is defined as a composite of all-cause death, myocardial re-infarction and unscheduled cardiovascular re-hospitalization.
From the date of randomization until the first documented event during the follow-up period (up to 12 months).

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
All cause death
Time Frame: From the date of randomization until the first documented event during the follow-up period (up to 12 months).
Death from any cause.
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 experiencing myocardial re-infarction
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 unscheduled cardiovascular re-hospitalization
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 experiencing cardiovascular-related death
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 hospitalized for heart failure
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 participants expiring hospitalization from any cause
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 patients experiencing a stroke
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).
Number of participants with a bleeding event
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).
An economic evaluation will be conducted from the healthcare payer perspective. Direct healthcare costs, including intervention costs, hospitalizations, outpatient visits, diagnostic procedures, and concomitant medications, will be collected prospectively for each participant over the study period. Mean total healthcare costs per patient will be calculated and compared between study groups.
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
Number of days in hospital from time of infarction to hospital discharge
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).
Percentage of patients on guideline-directed therapy
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
Infection leading to hospitalization
At 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medical University Innsbruck

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Martin Reindl, MD, PhD, Medical University Innsbruck
  • Principal Investigator: Sebastian J Reinstadler, MD, PhD, Medical University of Innsbruck

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 13, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 20, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1284/2024
  • 20241113-3609 (Other Identifier: Medical University Innsbruck)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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