- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06744322
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
Recruiting
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Estimated)
2070
Phase
- 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
- Name: Martin Reindl, MD, PhD
- Phone Number: +43 512 504 25665
- Email: martin.reindl@tirol-kliniken.at
Study Contact Backup
- Name: Ivan Lechner, MD, PhD
- Email: ivan.lechner@tirol-kliniken.at
Study Locations
-
-
Lower Austria
-
Wiener Neustadt, Lower Austria, Austria, 2700
- Recruiting
- Hospital Wiener Neustadt
-
Contact:
- Franz Xaver Roithinger
- Email: franzxaver.roithinger@wienerneustadt.lknoe.at
-
-
Salzburg
-
Salzburg, Salzburg, Austria, 5020
- Recruiting
- Paracelsus Medical University Salzburg
-
Contact:
- Uta Hoppe
- Email: u.hoppe@salk.at
-
-
Schwarzach Im Pongau
-
Schwarzach im Pongau, Schwarzach Im Pongau, Austria, 5620
- Not yet recruiting
- Cardinal Schwarzenberg Hospital Schwarzach
-
Contact:
- Email: discharge@i-med.ac.at
-
-
Styria
-
Graz, Styria, Austria, 8010
- Recruiting
- Medical University of Graz
-
Contact:
- Dirk von Lewinski
- Email: dirk.von-lewinski@medunigraz.at
-
-
Tyrol
-
Innsbruck, Tyrol, Austria, 6020
- Recruiting
- Medical University of Innsbruck
-
Contact:
- Martin Reindl, MD, PhD
- Phone Number: +43 512 504 25665
- Email: martin.reindl@tirol-kliniken.at
-
Contact:
- Sebastian J Reinstadler, MD, PhD
- Email: sebastian.reinstadler@tirol-kliniken.at
-
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
- Recruiting
- University Teaching Hospital Wels-Grieskirchen
-
Contact:
- Ronald Binder
- Email: Ronald.Binder@klinikum-wegr.at
-
-
Vorarlberg
-
Feldkirch, Vorarlberg, Austria, 6800
- Recruiting
- Academic Teaching Hospital Feldkirch
-
Contact:
- Matthias Frick
- Email: matthias.frick@lkhf.at
-
-
-
-
Bavaria
-
Munich, Bavaria, Germany, 81377
- Not yet recruiting
- Ludwig Maximilian University Munich
-
Contact:
- Steffen Massberg
- Email: steffen.massberg@med.uni-muenchen.de
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
Experimental: Fast discharge strategy
Fast discharge at 24 (+/-12) hours after invasive management of acute myocardial infarction.
|
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
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
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
Investigators
- 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)
December 1, 2024
Primary Completion (Estimated)
December 31, 2029
Study Completion (Estimated)
December 31, 2029
Study Registration Dates
First Submitted
December 13, 2024
First Submitted That Met QC Criteria
December 19, 2024
First Posted (Actual)
December 20, 2024
Study Record Updates
Last Update Posted (Actual)
March 16, 2026
Last Update Submitted That Met QC Criteria
March 11, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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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