Status:
NOT_YET_RECRUITING
Optimized Strategies for Malperfusion Syndrome
Lead Sponsor:
Xiamen Cardiovascular Hospital, Xiamen University
Conditions:
Aortic Dissection
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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). Objective...
Detailed Description
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 traditio...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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;
Key Trial Info
Start Date :
August 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 30 2026
Estimated Enrollment :
236 Patients enrolled
Trial Details
Trial ID
NCT06532838
Start Date
August 1 2024
End Date
October 30 2026
Last Update
August 1 2024
Active Locations (1)
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1
Xiamen Cardiovascular Hospital at Xiamen University
Xiamen, Fujian, China, 361008