Fast Discharge After Acute Myocardial Infarction Discharge MI

NCT06744322 | Recruiting DMC

• 2 other identifiers: 1284/202420241113-3609
• Study Type: interventional
• Target: 2,070
• Locations: 2 countries
• Sites: 8

Brief Summary

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.

Conditions

Acute Myocardial Infarction (AMI)

Keywords

Myocardial Infarction; STEMI; NSTEMI; Discharge; Randomized

Outcome Measures

Primary Outcomes (1)

• MACE

  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 Outcomes (12)

• All cause death

  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

  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

  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).

Study Arms (2)

Standard Care

NO INTERVENTION

Patients undergo a standard post-infarction care, with discharge at \>36 hours after invasive management of acute myocardial infarction.

Fast discharge strategy

EXPERIMENTAL

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

Procedure: Fast discharge strategy

Interventions

Fast discharge strategy PROCEDURE

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

Fast discharge strategy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University Innsbruck: lead

Study Sites (8)

Hospital Wiener Neustadt

Wiener Neustadt, Lower Austria, 2700, Austria

RECRUITING

Paracelsus Medical University Salzburg

Salzburg, Salzburg, 5020, Austria

RECRUITING

Cardinal Schwarzenberg Hospital Schwarzach

Schwarzach im Pongau, Schwarzach Im Pongau, 5620, Austria

NOT YET RECRUITING

Medical University of Graz

Graz, Styria, 8010, Austria

RECRUITING

Medical University of Innsbruck

Innsbruck, Tyrol, 6020, Austria

RECRUITING

University Teaching Hospital Wels-Grieskirchen

Wels, Upper Austria, 4600, Austria

RECRUITING

Academic Teaching Hospital Feldkirch

Feldkirch, Vorarlberg, 6800, Austria

RECRUITING

Ludwig Maximilian University Munich

Munich, Bavaria, 81377, Germany

NOT YET RECRUITING

MeSH Terms

Conditions

Myocardial Infarction; ST Elevation Myocardial Infarction; Non-ST Elevated Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Martin Reindl, MD, PhD

  Medical University Innsbruck

  PRINCIPAL INVESTIGATOR

• Sebastian J Reinstadler, MD, PhD

  Medical University of Innsbruck

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martin Reindl, MD, PhD

CONTACT

+43 512 504 25665; martin.reindl@tirol-kliniken.at

Ivan Lechner, MD, PhD

CONTACT

ivan.lechner@tirol-kliniken.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2024
• First Posted: December 20, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: March 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1); AU (7)