NCT06744322RecruitingNot Applicable
Fast Discharge After Acute Myocardial Infarction Discharge MI - A Randomized Multicenter Non Inferiority Trial
Medical University Innsbruck15 sites in 2 countries2,070 target enrollmentStarted: December 1, 2024Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 2,070
- Locations
- 15
- Primary Endpoint
- MACE
Study Overview
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.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Fast discharge strategy (Procedure)
Outcomes
Primary Outcomes
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
- 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).)
- 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(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(From the date of randomization until the first documented event during the follow-up period (up to 12 months).)
- Length of hospital stay(From the date of randomization to the date of hospital discharge, for up to 100 days)
- 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(At 30 days)
Investigators
Study Sites (15)
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