Optimized Strategies for Malperfusion Syndrome

NCT06532838 · tracked via the Priya Life Science China tracker

Sponsor

Xiamen Cardiovascular Hospital, Xiamen University

Phase

Not applicable

Started

2024-08-01

Last updated

2024-08-01

Condition(s) studied

Aortic Dissection

Investigational drug(s) / intervention(s)

Optimized treatment strategiesTraditional treatment strategies

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.

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.

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

Inclusion Criteria: * 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: 1. Radiographic findings reveal occlusion of the corresponding arteries (including either coronary artery, either carotid artery, celiac trunk, superior mesenteric artery or either iliac artery); 2. 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). Exclusion Criteria: * 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;

Primary outcome measure(s)

Operative Mortality (OM) — 30-day
Patients who died within 30 days

Trial sites (1)

Facility	City	Region	Status
Xiamen Cardiovascular Hospital at Xiamen University	Xiamen	Fujian

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06532838 on ClinicalTrials.gov ↗ ← All trials in China