Clinical trial NCT06532838: Optimized Strategies for Malperfusion Syndrome
Official title: Optimized Strategies for Acute Type A Aortic Dissection Complicated With MalPerfusion Syndrome (OPTIMIZE-MPS)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Aortic Dissection
Keywords: Malperfusion syndrome
Aortic dissection
Optimized strategies
Central repair
Endovascular reperfusion
Lead sponsor: Xiamen Cardiovascular Hospital, Xiamen University
Sponsor class: OTHER
First posted: 2024-08-01
Enrollment: 236
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

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).

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.

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 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.

Eligibility criteria: 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 outcomes:
measure: Operative Mortality (OM)
timeFrame: 30-day
Secondary outcomes:
measure: Rate of composite of Major Adverse Events (MAE)
timeFrame: 30-day
measure: Rate of composite of Major Adverse Pulmonary Events (MAPE)
timeFrame: 30-day
measure: Rate of reintervention
timeFrame: 3 year
measure: Mid-term survival
timeFrame: 3 year
Other outcomes:
Locations:
city: Xiamen
country: China
facility: Xiamen Cardiovascular Hospital at Xiamen University
state: Fujian
Study officials:
References: