Standby Cannulated ECMO for High-Risk Percutaneous Coronary Intervention
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: Standby cannulated ECMO, Prophylactic ECMO.
- Кому может быть актуально
- Состояния в реестре: ECMO, High-risk PCI. 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
- Китай
- 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
Standby Cannulated ECMO Versus Prophylactic ECMO In Patients Undergoing High-Risk Percutaneous Coronary Intervention
Обзор
The goal of this multicenter, randomized trial is to compare standby cannulated ECMO versus prophylactic ECMO in patients undergoing high-risk percutaneous coronary intervention (PCI). The main question it aims to answer is : • If standby cannulated ECMO as compared with prophylactic ECMO will improve the outcomes in patients undergoing high-risk PCI
Подробное описание
Although coronary artery bypass grafting is generally preferred in symptomatic patients with severe, complex multivessel, or left main disease, some patients present with clinical features that make coronary artery bypass grafting clinically unattractive. Percutaneous coronary intervention (PCI) with hemodynamic support may be feasible for these high-risk patients. Veno-arterial extracorporeal membrane oxygenation (VA-ECMO) can be used to provide hemodynamic support during high-risk PCI procedures. However, ECMO might increase the rates of severe complications, such as bleeding and limb ischemia. Additionally, some patients might not need the support of ECMO. In this context, investigators propose a standby cannulated ECMO strategy, in which femoral cannulas are inserted and connected to primed circuit, and ECMO is initiated when needed. Therefore, investigators will conduct a prospective randomized clinical trial to compare outcomes between standby cannulated ECMO versus prophylactic ECMO in patients undergoing high-risk PCI. Investigators will randomly assign 176 symptomatic patients with complex 3-vessel disease or unprotected left main coronary artery disease or severely depressed left ventricular function to standby cannulated ECMO group (n=88) or prophylactic ECMO (n=88). The primary end point was the 30-day incidence of major adverse events, including all-cause death, myocardial infraction, any repeat revascularization procedure, stroke, PCI failure, limb ischemia, major bleeding, vascular injury requiring intervention, and need for renal replacement therapy.
Вмешательства
- Процедура Standby cannulated ECMO
Femoral cannulas are inserted and connected to the primed circuit. Clamps are kept on circuit, and ECMO is on standby during PCI. ECMO is initiated if needed. - Процедура Prophylactic ECMO
Prophylactic ECMO procedures are performed in the catheterization laboratory before PCI.
Первичные конечные точки
- Composite rate of 9 major adverse events [Срок оценки: 30 days]
Вторичные конечные точки (9)
- Post-procedural hemoglobin decline [Срок оценки: 30 days]
- Post-procedural platelet count decline [Срок оценки: 30 days]
- RBC transfusion rate [Срок оценки: 30 days]
- Serum interleukin-6 concentration [Срок оценки: 30 days]
- Duration of ECMO support [Срок оценки: 30 days]
- Length of hospital stay [Срок оценки: 30 days]
- Hospitalization cost [Срок оценки: 30 days]
- Use of intra-aortic balloon pump (IABP) [Срок оценки: 30 days]
- Each component of the composite major adverse events [Срок оценки: 30 days]
Критерии участия
Критерии включения
- Clinicians decide to perform PCI during ECMO support.
- Age of ≥18
- Patient presents with a compromised ejection fraction of less than 35% or at risk of hemodynamic deterioration, or intervention on the last patent coronary conduit or an unprotected left main artery, or complex 3-vessel disease (SYNTAX score of ≥33)
- Informed consent
Критерии исключения
- Subject in cardiogenic shock(need inotrope, pressor or mechanical support to maintain SBP >90mmHg)
- Presence of moderate to severe aortic insufficiency
- Severe peripheral vascular disease
- creatinine≥4mg/dL
- Liver dysfunction with elevation of liver enzymes and bilirubin levels to ≥ 3x ULN
- History of recent (within 1 month) stroke or TIA
- Abnormal coagulation(defined as platelet count ≤50000/mm3 or Fibrinogen ≤1.50g/L)
- Allergy or intolerance to heparin, aspirin, ADP receptor inhibitors, or documented heparin induced thrombocytopenia.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Китай · 1 центр
- Beijing Anzhen Hospital — Пекин
Идентификаторы
NCT: NCT06274411 · KS2024014