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NCT Number: NCT06744322

Fast Discharge After Acute Myocardial Infarction Discharge MI

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.

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Key information

Conditions

Acute Myocardial Infarction (AMI) Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Non-ST Elevated Myocardial Infarction Pathologic Processes Pathological Conditions, Signs and Symptoms ST Elevation Myocardial Infarction Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Wiener Neustadt, Wiener Neustadt, Lower Austria, Austria

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fast discharge strategy

Procedure

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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.

  10. 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

  11. 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

  12. Infection

    Time frame: At 30 days

    Infection leading to hospitalization

Study contacts

Contact information is provided by the study sponsor or research team.

Ivan Lechner, MD, PhD

CONTACT

[email protected]

Martin Reindl, MD, PhD

CONTACT

[email protected]

+43 512 504 25665

Sponsors and collaborators

Lead sponsor

Medical University Innsbruck

Other

Registry information

Official study title

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

Acronym: DISCHARGE-MI

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Dec 20, 2024
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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