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临床试验/NCT05517356
NCT05517356招募中不适用

PRospective Study of tailOred Management Strategies fOr Acute Type A Aortic Dissection complicatEd With Malperfusion Syndrome (PROMOTE)

Xiamen Cardiovascular Hospital, Xiamen University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2021年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
120
试验地点
1
主要终点
Mortality (number of all cause death)

研究概览

简要总结

Management strategy of malperfusion syndrome in acute type A aortic dissection (ATAAD) patients remains controversial, with different views on when the surgery should be offered. At present, the mortality of ATAAD patients complicated with malperfusion is stubbornly high.

The purpose of this study is to improve the outcomes of ATAAD with malperfusion syndrome. The investigators formulated tailored management strategies for malperfused patients based on the duration of symptoms onset.

详细描述

ATAAD complicated with malperfusion syndrome Malperfusion syndrome is the most devastating complication of acute type A aortic dissection (ATAAD), which has a poor clinical outcome and has operative mortality ranging from 29% to 89%. However, different views on management of malperfusion exist, with debating on addressing the dissection or the organ malperfusion in priority.

Current different treatment strategies for ATAAD with malperfusion syndrome Immediate central repair, restoration of true lumen flow and depressurization of the false lumen, is the most widely practiced approaches for treating ATAAD regardless of malperfusion syndrome. Nevertheless, with very high operative mortality by the conventional approach for patients with malperfusion, several studies have suggested that patients undergo endovascular reperfusion first until the malperfusion resolves, followed by delayed central repair. This strategy has produced better outcomes for patients, however, it also carries risks of interim mortality due to aortic rupture or multiple-organ failure before central repair. Moreover, a recent study suggested an alternative strategy, which performed aortic surgery and endovascular reperfusion in a hybrid approach for static malperfusion or dynamic malperfusion symptoms more than 6 hours symptoms onset. This alternative strategy improved outcomes with a mortality rate of 16.7%, which was still a little bit high. Overall, the outcomes of ATAAD patients with malperfusion syndrome still need to be improved.

Tailored management strategies The tailored management strategies were: for malperfused patients with symptom onset within 6 hours, the immediate central repair was performed followed by repeat CTA postoperatively, and endovascular reperfusion was applied if the malperfusion persisted. While for patients with symptom onset beyond 6 hours, delayed central repair were performed after the organ functions improved.

Study Rationale As noted above, malperfusion syndrome is a rapidly lethal condition that every cardiovascular surgeon is faced with at some point. Despite the optimization of approaches for ATAAD presented with malperfusion in recent years, there appears to be some room to improve our outcomes even further. The investigators believe that the tailored management strategies, which aimed at reducing the duration of end-organ ischemia, may provide a promising treatment option for these patients. However, further prospective study and follow-up data are necessary to confirm the efficacy and safety of this new strategy.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Acute type A aortic dissection is confirmed by CTA;
  • The symptoms onset time < 2 weeks;
  • Patients diagnosed with an 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 (abnormal left ventricular wall motion, disorder of consciousness or paralysis, abdominal pain, distended abdomen, pulselessness, loss of sensory or motor function of the lower extremities) OR Laboratory findings suggestive of end organ ischemia (elevated troponin, elevated creatine kinase, lactic acidosis, elevated myoglobin).

排除标准

  • The branch arteries did not involved by ATAAD (non-malperfusion);
  • Patients presented with bloody stools or melena on admission;
  • Patients presented with bilaterally fixed dilated pupils, hemorrhagic infarction or herniation of brain;
  • Patients and (or) their families refused surgery;

结局指标

主要结局

Mortality (number of all cause death)

时间窗: 12 months

All cause death

次要结局

  • Low cardiac output syndrome(30 days)
  • New cerebrovascular events(30 days)
  • Intestinal necrosis(30 days)
  • Lower limb necrosis(30 days)
  • Multiple organ failure(30 days)
  • Extracorporeal membrane oxygenation(30 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Xijie Wu

Director, Head of Cardiosurgery, Clinical Professor

Xiamen Cardiovascular Hospital, Xiamen University

研究点 (1)

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