Optimized Strategies for Malperfusion Syndrome

Официальное название

Optimized Strategies for Acute Type A Aortic Dissection Complicated With MalPerfusion Syndrome (OPTIMIZE-MPS)

Обзор

An investigator-initiated, randomized, multicenter, two-arm, open-label study of consecutive patients presenting with acute type A aortic dissection (ATAAD) and malperfusion syndrome (MPS). Objectives: The present study aimed to investigate the difference in all-cause mortality after optimized treatment strategies (OTS) versus traditional treatment strategies (TTS) for ATAAD patients with MPS. Background: The mortality of ATAAD with MPS is high. However, the management strategies of MPS patients still not to be confirmed. Compare with TTS, OTS as a strategy for ATAAD patients with MPS might have be beneficial results.

Подробное описание

A total of 236 subjects with ATAAD complicated with MPS who met inclusion criteria and do not have any exclusion criterion will be randomized to optimized treatment strategies (OTS) group and traditional treatment strategies (TTS) group.

1. Patients randomized to OTS group will be treated with optimized treatment strategies. The optimized strategies based on 6-hour threshold from symptom onset. For malperfused patients with symptom onset within 6 hours, central repair will be performed immediately. Additional stenting will be used in patients with persistent malperfusion. For malperfused patients with symptom onset beyond 6 hours, individualized delayed central repair according to the different types of MPS will be performed after organ function improved and the patient could tolerate central repair. 2. Patients randomized to TTS group will treated with traditional treatment strategies. Immediate central repair will performed for patients with coronary and cerebral malperfusion syndrome. However, for patients with mesenteric and lower extremity malperfusion syndrome, interventional therapy will be administered through fenestration and/or stenting to first alleviate organ ischemia. Once the patients had a resolution of organ failure, corrective open aortic repair will be performed.

Вмешательства

• Процедура Optimized treatment strategies
  The optimized strategies based on 6-hour threshold from symptom onset. For malperfused patients with symptom onset within 6 hours, central repair will be performed immediately. Additional stenting will be used in patients with persistent malperfusion. For malperfused patients with symptom onset beyond 6 hours, individualized delayed central repair according to the different types of MPS will be performed after organ function improved and the patient could tolerate central repair.
• Процедура Traditional treatment strategies
  Immediate central repair will be performed for patients with coronary and cerebral malperfusion syndrome. However, for patients with mesenteric and lower extremity malperfusion syndrome, interventional therapy will be administered through fenestration and/or stenting to first alleviate organ ischemia. Once the patients had a resolution of organ failure, corrective open aortic repair will be performed.

Первичные конечные точки

• Operative Mortality (OM) [Срок оценки: 30-day]

Вторичные конечные точки (4)

• Rate of composite of Major Adverse Events (MAE) [Срок оценки: 30-day]
• Rate of composite of Major Adverse Pulmonary Events (MAPE) [Срок оценки: 30-day]
• Rate of reintervention [Срок оценки: 3 year]
• Mid-term survival [Срок оценки: 3 year]

Критерии участия

Критерии включения

• Provision of informed consent prior to any study specific procedures;
• Acute type A aortic dissection is confirmed by computed tomography angiography;
• The symptoms onset within 2 weeks;
• Patients are diagnosed with ATAAD, with a new diagnosis of malperfusion syndrome ,by meeting both of the following criteria:

• Radiographic findings reveal occlusion of the corresponding arteries (including either coronary artery, either carotid artery, celiac trunk, superior mesenteric artery or either iliac artery);
• Clinical features of end organ ischemia (altered consciousness, paralysis, melena, abdominal pain, tenderness to palpation, loss of sensory or motor function of the lower extremities) OR laboratory findings suggestive of end organ ischemia (elevated cardiac enzymes, lactate, myoglobin, or creatine kinase).

Критерии исключения

• Age <18 yr and >80 yr;
• Unstable condition with cardiac tamponade or aortic rupture on admission;
• Multiple types of malperfusion syndrome on admission;
• Bloody stools or melena on admission;
• Bilaterally fixed dilated pupils, hemorrhagic infarction or herniation of brain on admission;
• Cardiopulmonary arrest and required continuous uninterrupted cardiopulmonary resuscitation on admission;
• Irreversible multiple organ failure on admission;
• Life expectancy < 1 year;
• Patients and (or) their families refused surgery;

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

• Xiamen Cardiovascular Hospital at Xiamen University — Xiamen

Идентификаторы

NCT: NCT06532838 · (2024) YLK-26

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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