Rapid Microaxial Flow Pump Support and Escalation in Patients With Myocardial Infarction Associated Cardiogenic Shock and Persistent Need of Hemodynamic Support (RISE)
24 августа 2026 г. обновлено: Stephan Baldus, University Hospital of Cologne
Rapid Impella Support and Escalation Trial
The aim of this trial is to evaluate whether a structured and time-optimized escalation strategy from a transfemoral microaxial flow-pump (Impella CP™) to the Impella 5.5™ microaxial flow-pump is associated with improved clinical outcomes and fewer adverse events in patients with cardiogenic shock due to acute myocardial infarction
Обзор исследования
Статус
Рекрутинг
Вмешательство/лечение
Подробное описание
By examining best-practice MCS management and the role of early escalation to Impella 5.5™ in clinical routine care for high-risk patients with deteriorating shock, the study seeks to investigate current treatment strategies that ensure the most appropriate device selection and support intensity at the earliest clinically meaningful time point.
This observational approach aims to advance the optimal management of ACS-CS while addressing the complications reported in the DanGer Shock trial.
Тип исследования
Наблюдательный
Регистрация (Оцененный)
115
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Контакты исследования
- Имя: Sebastian Heyne, Dr. med.
- Номер телефона: +4915125364083
- Электронная почта: sebastian.heyne@uk-koeln.de
Места учебы
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Cologne, Германия, 50937
- Рекрутинг
- University Hospital Cologne
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Контакт:
- Sebastian Heyne, Dr. med.
- Номер телефона: +49 221 478 84452
- Электронная почта: sebastian.heyne@uk-koeln.de
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North Rhine-Westphalia
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Düsseldorf, North Rhine-Westphalia, Германия, 40225
- Рекрутинг
- University Hospital Düsseldorf
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Контакт:
- Malte Kelm, Prof.
- Номер телефона: +49 211 8118801
- Электронная почта: kardiologie@med.uni-duesseldorf.de
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Schleswig-Holstein
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Kiel, Schleswig-Holstein, Германия, 24105
- Рекрутинг
- University Hospital Schleswig-Holstein, Campus Kiel
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Контакт:
- Bernd Panholzer, Dr.med.
- Номер телефона: +49 431 50028193
- Электронная почта: Bernd.Panholzer@uksh.de
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Нет
Метод выборки
Невероятностная выборка
Исследуемая популяция
Patients with ACS-CS (STEMI or NSTEMI) who undergo Impella CP™-supported revascularisation of the culprit lesion and are considered for escalation to Impella 5.5 at the discretion of the treating investigator will be assessed for eligibility to participate in this observational study.
Описание
Inclusion Criteria:
- Age ≥18 years and ≤77 years
- Patients with ACS-CS (STEMI and NSTEMI with a culprit lesion that received revascularisation) and Impella CP™ support during initial revascularisation
The following additional parameters must be met at the time of initial revascularisation procedure:
- Hypotension or need for inotropes AND
- Lactate > 2.5 mM AND
- Left ventricular ejection fraction (EF) < 45%
Need for escalation to Impella 5.5 at the discretion of the treating physician and the following criteria are fulfilled:
- Decision for Impella 5.5 escalation within 6 ± 1 hours after completion of initial revascularisation procedure
- Escalation to Impella 5.5procedure is initiated within 24 hours after completion of the initial revascularisation procedure
- Need for inotropes and/or vasopressors with VIS > 5 but ≤ 50 at Impella CP™ support at level P7 or above at 6+1 hours after completion of initial revascularisation procedure
- Prospective Informed Consent obtained from the patient or deferred consent according to "Cologne Model" applied.
Exclusion Criteria:
- Implanted VA-ECMOwithin 6 ± 1 hours after initial revascularisation Note: If VA-ECMO support is needed between 6 ± 1 hours after initial revascularisation and escalation to Impella 5.5, patients will be included forlimited data collection per Table 2 only. In this case the same Informed Consent Process as for regular trial participants applies.
- Elevated risk of hypoxic brain injury indicated by MIRACLE2 score >3 (Aldous et al., 2023)
- Platelet count <75,000 cells/mm3, bleeding diathesis or active bleeding, coagulopathy or unwillingness to receive blood transfusions
- Active bleeding (e.g. access site bleeding or GI bleeding, etc.) with need for transfusion within 6 ± 1 hours after initial revascularisation
- Any contraindication listed in the Impella 5.5 IFU if known to be present
- Chronic haemodialysis and/or chronic kidney disease stage G5 according to KDIGO
- Pregnancy or lactation, if known
- Participation in the active treatment or follow-up phase of another clinical study of an investigational drug or device that has not reached its primary endpoint, if known
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
Вмешательство/лечение |
|---|---|
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Device Group
Rapid escalation to Impella 5.5
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Rapid escalation from Impella CP to Impella 5.5 within 24 hours post revascularization
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Vasoactive Hemodynamic Score (VHS) < 5
Временное ограничение: 48 hours post revascularization
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Vasoactive Hemodynamic Score = Hemodynamic Score (HS) x Vasoactive-Inotropic Score (VIS) Higher VHS indicates more severe hemodynamic compromise relative to degree of pharmacological circulatory support. Range: Minimum 1, Maximum 110 Hemodynamic Score: HS = Points are allocated for measured heart rate, mean arterial blood pressure and arterial lactate (minimum 1, maximum 11) Vasoactive-Inotropic Score: Points are allocated for every 10 increment according to the following formula: Dopamine dose (μg/kg/min) + Dobutamine dose (μg/kg/min) + 100 x Epinephrine dose (μg/kg/min) + 10 x Milrinone (μg/kg/min) + 100 x Norepinephrine dose (μg/kg/min) + 50 x Levosimendan dose (μg/kg/min) |
48 hours post revascularization
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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All-cause mortality
Временное ограничение: In-hospital or 30 days post revascularization (whatever comes first)
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In-hospital or 30 days post revascularization (whatever comes first)
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All-cause mortality
Временное ограничение: 180 days post revascularization
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180 days post revascularization
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Cardiac output
Временное ограничение: At time of enrolment, 48 hours as well as 72 hours post revascularization.
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measured by pulmonary artery catheter (PAC) [l/min]
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At time of enrolment, 48 hours as well as 72 hours post revascularization.
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Vasoactive-Inotropic Score (VIS)
Временное ограничение: At time of enrolment, 48 hours as well as 72 hours post revascularization.
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Vasoactive-Inotropic Score (VIS): A composite measure of vasoactive and inotropic medication support. Scores range from 0 to no fixed maximum, with higher scores indicating greater vasoactive/inotropic support requirements and therefore a worse clinical status and prognosis. VIS=dopamine + dobutamine + 100×epinephrine + 10×milrinone + 10,000×vasopressin + 100×norepinephrine (all doses in μg/kg/min except vasopressin in U/kg/min) |
At time of enrolment, 48 hours as well as 72 hours post revascularization.
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Lactate
Временное ограничение: At time of enrolment, 48 hours as well as 72 hours post revascularisation
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Arterial lactate measured by blood gas analysis [mmol/l]
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At time of enrolment, 48 hours as well as 72 hours post revascularisation
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Perfusion
Временное ограничение: At time of enrolment and 48 hours post revascularization.
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Enhanced perfusion of the limb used for Impella CP™ access by comparing NIRS measurements [%]
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At time of enrolment and 48 hours post revascularization.
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Major Bleeding
Временное ограничение: During the index hospitalization, specifically from timepoint of initial revascularisation until discharge from the index hospitalization or death of any cause (whichever comes first) until the first documented bleeding event.
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Either according to BARC classification (BARC ≥ IIIa) or GUSTO classification (at least moderate bleeding)
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During the index hospitalization, specifically from timepoint of initial revascularisation until discharge from the index hospitalization or death of any cause (whichever comes first) until the first documented bleeding event.
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Ischemia of the extremities
Временное ограничение: During the index hospitalization, specifically from timepoint of initial revascularisation until discharge from the index hospitalization or death of any cause (whichever comes first) at the timepoint of intervention/surgery assessed up to 30 days.
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Peripheral vascular ischemia (femoral and axillary) with indication to percutaneous intervention or surgical repair
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During the index hospitalization, specifically from timepoint of initial revascularisation until discharge from the index hospitalization or death of any cause (whichever comes first) at the timepoint of intervention/surgery assessed up to 30 days.
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Haemolysis
Временное ограничение: At time of enrolment, 48 hours as well as 72 hours post revascularization.
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Prevalence of clinically relevant haemolysis according to SHARC definitions
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At time of enrolment, 48 hours as well as 72 hours post revascularization.
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Cerebral events
Временное ограничение: During the index hospitalization, specifically from timepoint of initial revascularisation until discharge from the index hospitalization or death of any cause (whichever comes first) assessed up to 30 days.
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Cerebral ischemia or cerebral bleeding assessed via standard-of-care neurological assessment and/or imaging
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During the index hospitalization, specifically from timepoint of initial revascularisation until discharge from the index hospitalization or death of any cause (whichever comes first) assessed up to 30 days.
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Acute kidney injury (AKI)
Временное ограничение: Every event during the index hospitalization, specifically from timepoint of initial revascularisation until discharge from the index hospitalization or death of any cause (whichever comes first), assessed at the timepoint of occurence up to 30 days.
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Acute kidney injury (AKIN level 2 or greater) and/or need for renal replacement therapy (RRT)
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Every event during the index hospitalization, specifically from timepoint of initial revascularisation until discharge from the index hospitalization or death of any cause (whichever comes first), assessed at the timepoint of occurence up to 30 days.
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Sepsis with positive blood culture
Временное ограничение: During the index hospitalization, specifically from timepoint of initial revascularisation until discharge from the index hospitalization or death of any cause (whichever comes first) at the timpoint of first positive blood culture up to 30 days.
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During the index hospitalization, specifically from timepoint of initial revascularisation until discharge from the index hospitalization or death of any cause (whichever comes first) at the timpoint of first positive blood culture up to 30 days.
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Access site infection
Временное ограничение: During the index hospitalization, specifically from timepoint of initial revascularisation until discharge from the index hospitalization or death (whichever comes first), at the timepoint of surgical intervention up to 30 days.
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Access site infection with the need to surgical intervention
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During the index hospitalization, specifically from timepoint of initial revascularisation until discharge from the index hospitalization or death (whichever comes first), at the timepoint of surgical intervention up to 30 days.
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Time to extubation
Временное ограничение: At 30 days post revascularization
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Time to extubation in hours
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At 30 days post revascularization
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Time to ambulation
Временное ограничение: At 30 days post revascularization
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Time to ambulation in hours
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At 30 days post revascularization
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Cumulative incidence of escalation to VA-ECMO, LVAD or heart transplant
Временное ограничение: At 30 days and 180 days post revascularization
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Cumulative incidence of escalation to VA-ECMO, LVAD or heart transplant
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At 30 days and 180 days post revascularization
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Major adverse kidney events (MAKE)
Временное ограничение: At 30 days and 180 days post revascularization
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Death (from any cause) or new requirement for renal replacement therapy (RRT) (e.g., dialysis) or persistent renal dysfunction (PRD) (defined as a worsening of kidney function denoted by ≥ 25% decline in the estimated glomerular filtration rate (eGFR) from baseline)
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At 30 days and 180 days post revascularization
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Соавторы
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Действительный)
23 апреля 2026 г.
Первичное завершение (Оцененный)
1 октября 2028 г.
Завершение исследования (Оцененный)
1 октября 2028 г.
Даты регистрации исследования
Первый отправленный
21 апреля 2026 г.
Впервые представлено, что соответствует критериям контроля качества
15 июня 2026 г.
Первый опубликованный (Действительный)
17 июня 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
27 августа 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
24 августа 2026 г.
Последняя проверка
1 августа 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 25-1387
- HORIZON-JU-IHI-2025-09 (Другой номер гранта/финансирования: IHI Joint Undertaking)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
НЕТ
Описание плана IPD
Due to data protection regulations and study contracts
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Да
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .