Optimized Strategies for Malperfusion Syndrome

NCT ID: NCT06532838

Last Updated: 2024-08-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 236 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-01
• Study Completion Date: 2026-10-30

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.

Conditions

Aortic Dissection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Optimized treatment strategies (OTS group)

Patients randomized to OTS group will be treated with optimized treatment strategies.

Group Type: EXPERIMENTAL

Optimized treatment strategies

Intervention Type: PROCEDURE

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 (TTS group)

Patients randomized to TTS group will be treated with traditional treatment strategies.

Group Type: ACTIVE_COMPARATOR

Traditional treatment strategies

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xiamen Cardiovascular Hospital, Xiamen University

OTHER

Sponsor Role: lead

Responsible Party

Xijie Wu

Director, Head of Cardiovascular Surgery, Principal Investigator, Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Xiamen Cardiovascular Hospital at Xiamen University

Xiamen, Fujian, China

Countries

China

Facility Contacts

Xijie Wu

Role: primary

wxjusa@163.com

+86-13365910050

Shuangkun Chen

Role: backup

shuangkun_chen@foxmail.com

+86-15695904322

Other Identifiers

(2024) YLK-26

Identifier Type: -

Identifier Source: org_study_id