Xiamen Cardiovascular Hospital at Xiamen University
Xiamen, Fujian, 361008, China
Location contact
Shuangkun Chen
CONTACT
Xijie Wu
CONTACT
NCT Number: NCT06532838
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.
Trial opening soon.
Get Notified18 year–80 year
All sexes
Interventional
Not applicable
Xiamen, Fujian, 361008, China
Shuangkun Chen
CONTACT
Xijie Wu
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 30-day
Patients who died within 30 days
Time frame: 30-day
Number of participants with MAE which will include the composite rate of low cardiac output syndrome, new cerebrovascular accident, intestinal ischemia, lower limb necrosis, multiple organ failure according to Common Terminology Criteria for Adverse Events v4.0 (CTCAE)
Time frame: 30-day
Number of participants with MAPE which will include the composite rate of intubation >48 hours, pneumonia, reintubation, tracheostomy according to the Common Terminology Criteria for Adverse Events v4.0 (CTCAE)
Time frame: 3 year
The number of participants who will require reoperation for distal aorta
Time frame: 3 year
The secondary endpoint of the study is the evaluation of mid-term survival
Xiamen Cardiovascular Hospital, Xiamen University
Other
Optimized Strategies for Acute Type A Aortic Dissection Complicated With MalPerfusion Syndrome (OPTIMIZE-MPS)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07379294
AORTIC VALVE DISEASES, Acute Aortic Syndrome
View Trial DetailsNCT07521488
Acute Aortic Syndrome, Aneurysm
Beijing, Beijing Municipality, China
View Trial DetailsNCT07495267
Abnormalities, Multiple, Acute Aortic Syndrome
View Trial DetailsNCT07387250
Acute Aortic Syndrome, Aneurysm
View Trial Details