Fast Discharge After Acute Myocardial Infarction Discharge MI
ConditionAcute Myocardial Infarction (AMI)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedical University Innsbruck
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Fast discharge strategy
Procedure/SurgeryPatients undergoing invasive management after myocardial infarction will be discharged after 24 (+/- 12) hours.
Treatment groups
2,070 Participants
are divided into 2 treatment groupsGroup A: Standard CareNo intervention 0 interventions
Group B: Fast discharge strategyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
MACE
MACE is defined as a composite of all-cause death, myocardial re-infarction and 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).Secondary outcomes
1
All cause death
Death from any cause.
Time frame
From the date of randomization until the first documented event during the follow-up period (up to 12 months).2
Number of participants with myocardial re-infarction
Number of participants experiencing myocardial re-infarction
Time frame
From the date of randomization until the first documented event during the follow-up period (up to 12 months).3
Number of participants with unscheduled cardiovascular re-hospitalization
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).4
Number of participants with Cardiovascular death
Number of participants experiencing cardiovascular-related death
Time frame
From the date of randomization until the first documented event during the follow-up period (up to 12 months).Sponsors and contacts
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Source ClinicalTrials.gov