CorVad Myocardial Infarction Complicated with Cardiogenic Shock Trial

Официальное название

Effects of CorVad Percutaneous Mechanical Circulatory Support in Patients with ST Segment Elevation Myocardial Infarction Complicated by Cardiogenic Shock.

Обзор

Cardiogenic shock a serious complication of a heart attack (myocardial infarction). Despite evaluation of several new treatments during the last decade, the mortality in patients with cardiogenic shock still exceeds 50%. An alternative to current management is restoration of the volume of blood pumped by the heart (cardiac output) using a ventricular assist device. In the acute setting this is difficult but can be done using the CorVad device which is a catheter-based, axial flow pump that pumps blood directly from the left ventricle into the circulation thereby restoring blood flow to the failing organs. The hypothesis of the current study is to reduce mortality and morbidity of patients with cardiogenic shock using the CorVad device. The study will be carried out as a randomized multicenter study where eligible patients will be randomized to receive conventional circulatory support or support with the CorVad device and inotropic support if needed. A total of 269 patients are planned

Подробное описание

The study is a prospective, multicenter trial in patients with AMICS randomized 1:1 to CorVad or current guideline-driven therapy with planned enrollment of 269 patients. Patients comatose after out of hospital cardiac arrest are excluded. Eligible patients are randomized immediately following shock diagnosis. Among patients randomized to receive CorVad, the device is placed prior to angioplasty. The primary endpoint is all-cause mortality at 180 days.The target population of subjects are patients with acute myocardial infarction with cardiogenic shock who need high-risk PCI treatment, and sign an informed consent form (ICF) approved by the Ethics Committee (EC). Subjects who meet the enrolment criteria as judged by the investigator will apply the trial product according to the requirements and will be followed up to 180 days after the procedure.

Вмешательства

• Устройство Conventional circulatory support
  Control group treated with conventional circulatory support and observed in intensive care unit for a minimum of 48 hrs
• Устройство CorVad
  Control group treated with Impella CP for a minimum of 48 hrs

Первичные конечные точки

• Death [Срок оценки: up to 6 months]

Вторичные конечные точки (3)

• MACCE [Срок оценки: minimum follow-up 6 months]
• Composite saftey [Срок оценки: up to 6 months]
• Days alive out of hospital [Срок оценки: up to 6 months]

Критерии участия

Критерии включения

• ST segment elevation myocardial infarction of less than 36 hours' duration, confirmed by new onset ST-segment elevation, or emergency angiography demonstrating acute occlusion of coronary artery, and
• Cardiogenic shock of less than 24 hours' duration, confirmed by:

peripheral signs of tissue hypoperfusion (arterial blood lactate ≥2.5mmol/l and/or SvO2 <55% with a normal PaO2) and systolic blood pressure less than 100mmHg and/or need for vasopressor therapy (dopamine/ norepinephrine or epinephrine), and

• Left ventricular ejection fraction of less than 45% visually estimated or by wall motion score index >1,6.

Критерии исключения

• Shock duration N24 hours
• Other causes of shock; hypovolemia, sepsis, pulmonary embolism or anaphylaxis
• Shock due to mechanical complication to myocardial infarction; papillary muscle rupture, rupture of the ventricular septum or rupture of ventricular free wall.
• Severe aorta valve regurgitation/stenosis
• Severe peripheral arterial obstructive disease that would preclude Impella device placement
• Mechanical aortic valve prosthesis
• Already established mechanical circulatory support (Impella or VA-ECMO)
• Left ventricular thrombus
• Infective endocarditis
• Shock due to right ventricular failure
• Out of hospital cardiac arrest with persistent Glasgow coma scale b8 after return of spontaneous circulation. Cardiac arrest occurring in ambulance or after arrival to hospital is not an exclusion criterion.
• Subject with documented heparin induced thrombocytopenia.
• Life expectancy of less than 1 year due to comorbidities.
• Mental disorder or language barrier that preclude informed

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The Second Affiliated Hospital of Zhejiang University School of Medicine — Ханчжоу

Идентификаторы

NCT: NCT06886113 · COREMED_Corvad_AMICS

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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