Идёт набор NCT06744322

Fast Discharge After Acute Myocardial Infarction Discharge MI

Без фазы С лечением Acute Myocardial Infarction (AMI)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Fast discharge strategy.
Кому может быть актуально: Состояния в реестре: Acute Myocardial Infarction (AMI). Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Австрия, Германия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

MACE [Срок оценки: From the date of randomization until the first documented event during the follow-up period (up to 12 months).]

Вторичные конечные точки (12)

All cause death [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: From the date of randomization until the first documented event during the follow-up period (up to 12 months).]
Length of hospital stay [Срок оценки: From the date of randomization to the date of hospital discharge, for up to 100 days]
Percentage of patients on guideline-directed therapy [Срок оценки: From the date of randomization until the first documented event during the follow-up period (up to 12 months).]
Infection [Срок оценки: At 30 days]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет