Optimized Strategies for Malperfusion Syndrome

Not Applicable

Not yet recruiting

• Conditions: Aortic Dissection
• Interventions: Procedure: Optimized treatment strategies; Procedure: Traditional treatment strategies

• Registration Number: NCT06532838
• Lead Sponsor: Xiamen Cardiovascular Hospital, Xiamen University

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.

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-26
• Study First Submitted QC: 2024-07-31
• Last Update Submitted: 2024-07-31
• Study Start: 2024-08-01
• Study First Posted: 2024-08-01
• Last Update Posted: 2024-08-01
• Primary Completion: 2026-07-30
• Study Completion: 2026-10-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 236

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Optimized treatment strategies (OTS group)	Optimized treatment strategies	Patients randomized to OTS group will be treated with optimized treatment strategies.
Traditional treatment strategies (TTS group)	Traditional treatment strategies	Patients randomized to TTS group will be treated with traditional treatment strategies.

Primary Outcome Measures

Name	Time	Method
Operative Mortality (OM)	30-day	Patients who died within 30 days

Secondary Outcome Measures

Name	Time	Method
Rate of composite of Major Adverse Pulmonary Events (MAPE)	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)
Mid-term survival	3 year	The secondary endpoint of the study is the evaluation of mid-term survival
Rate of composite of Major Adverse Events (MAE)	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)
Rate of reintervention	3 year	The number of participants who will require reoperation for distal aorta

Trial Locations

Locations (1)

Xiamen Cardiovascular Hospital at Xiamen University; 🇨🇳 Xiamen, Fujian, China